Publications by authors named "Helen V Worthington"

156 Publications

Direct composite resin fillings versus amalgam fillings for permanent posterior teeth.

Cochrane Database Syst Rev 2021 08 13;8:CD005620. Epub 2021 Aug 13.

Argentine Dental Association (AOA), Buenos Aires, Argentina.

Background: Traditionally, amalgam has been used for filling cavities in posterior teeth, and it continues to be the restorative material of choice in some low- and middle-income countries due to its effectiveness and relatively low cost. However, there are concerns over the use of amalgam restorations (fillings) with regard to mercury release in the body and the environmental impact of mercury disposal. Dental composite resin materials are an aesthetic alternative to amalgam, and their mechanical properties have developed sufficiently to make them suitable for restoring posterior teeth. Nevertheless, composite resin materials may have potential for toxicity to human health and the environment. The United Nations Environment Programme has established the Minamata Convention on Mercury, which is an international treaty that aims "to protect the [sic] human health and the environment from anthropogenic emissions and releases of mercury and mercury compounds". It entered into force in August 2017, and as of February 2021 had been ratified by 127 governments. Ratification involves committing to the adoption of at least two of nine proposed measures to phase down the use of mercury, including amalgam in dentistry. In light of this, we have updated a review originally published in 2014, expanding the scope of the review by undertaking an additional search for harms outcomes. Our review synthesises the results of studies that evaluate the long-term effectiveness and safety of amalgam versus composite resin restorations, and evaluates the level of certainty we can have in that evidence.

Objectives: To examine the effects (i.e. efficacy and safety) of direct composite resin fillings versus amalgam fillings.

Search Methods: An information specialist searched five bibliographic databases up to 16 February 2021 and used additional search methods to identify published, unpublished and ongoing studies SELECTION CRITERIA: To assess efficacy, we included randomised controlled trials (RCTs) comparing dental composite resin with amalgam restorations in permanent posterior teeth that assessed restoration failure or survival at follow-up of at least three years. To assess safety, we sought non-randomised studies in addition to RCTs that directly compared composite resin and amalgam restorative materials and measured toxicity, sensitivity, allergy, or injury.

Data Collection And Analysis: We used standard methodological procedures expected by Cochrane.

Main Results: We included a total of eight studies in this updated review, all of which were RCTs. Two studies used a parallel-group design, and six used a split-mouth design. We judged all of the included studies to be at high risk of bias due to lack of blinding and issues related to unit of analysis. We identified one new trial since the previous version of this review (2014), as well as eight additional papers that assessed safety, all of which related to the two parallel-group studies that were already included in the review. For our primary meta-analyses, we combined data from the two parallel-group trials, which involved 1645 composite restorations and 1365 amalgam restorations in 921 children. We found low-certainty evidence that composite resin restorations had almost double the risk of failure compared to amalgam restorations (risk ratio (RR) 1.89, 95% confidence interval (CI) 1.52 to 2.35; P < 0.001), and were at much higher risk of secondary caries (RR 2.14, 95% CI 1.67 to 2.74; P < 0.001). We found low-certainty evidence that composite resin restorations were not more likely to result in restoration fracture (RR 0.87, 95% CI 0.46 to 1.64; P = 0.66). Six trials used a split-mouth design. We considered these studies separately, as their reliability was compromised due to poor reporting, unit of analysis errors, and variability in methods and findings. Subgroup analysis showed that the findings were consistent with the results of the parallel-group studies. Three trials investigated possible harms of dental restorations. Higher urinary mercury levels were reported amongst children with amalgam restorations in two trials, but the levels were lower than what is known to be toxic. Some differences between amalgam and composite resin groups were observed on certain measures of renal, neuropsychological, and psychosocial function, physical development, and postoperative sensitivity; however, no consistent or clinically important harms were found. We considered that the vast number of comparisons made false-positive results likely. There was no evidence of differences between the amalgam and composite resin groups in neurological symptoms, immune function, and urinary porphyrin excretion. The evidence is of very low certainty, with most harms outcomes reported in only one trial.

Authors' Conclusions: Low-certainty evidence suggests that composite resin restorations may have almost double the failure rate of amalgam restorations. The risk of restoration fracture does not seem to be higher with composite resin restorations, but there is a much higher risk of developing secondary caries. Very low-certainty evidence suggests that there may be no clinically important differences in the safety profile of amalgam compared with composite resin dental restorations. This review supports the utility of amalgam restorations, and the results may be particularly useful in parts of the world where amalgam is still the material of choice to restore posterior teeth with proximal caries. Of note, however, is that composite resin materials have undergone important improvements in the years since the trials informing the primary analyses for this review were conducted. The global phase-down of dental amalgam via the Minamata Convention on Mercury is an important consideration when deciding between amalgam and composite resin dental materials. The choice of which dental material to use will depend on shared decision-making between dental providers and patients in the clinic setting, and local directives and protocols.
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http://dx.doi.org/10.1002/14651858.CD005620.pub3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8407050PMC
August 2021

Visual or visual-tactile examination to detect and inform the diagnosis of enamel caries.

Cochrane Database Syst Rev 2021 06 14;6:CD014546. Epub 2021 Jun 14.

Dundee Dental School, University of Dundee, Dundee, UK.

Background: The detection and diagnosis of caries at the initial (non-cavitated) and moderate (enamel) levels of severity is fundamental to achieving and maintaining good oral health and prevention of oral diseases. An increasing array of methods of early caries detection have been proposed that could potentially support traditional methods of detection and diagnosis. Earlier identification of disease could afford patients the opportunity of less invasive treatment with less destruction of tooth tissue, reduce the need for treatment with aerosol-generating procedures, and potentially result in a reduced cost of care to the patient and to healthcare services.

Objectives: To determine the diagnostic accuracy of different visual classification systems for the detection and diagnosis of non-cavitated coronal dental caries for different purposes (detection and diagnosis) and in different populations (children or adults).

Search Methods: Cochrane Oral Health's Information Specialist undertook a search of the following databases: MEDLINE Ovid (1946 to 30 April 2020); Embase Ovid (1980 to 30 April 2020); US National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov, to 30 April 2020); and the World Health Organization International Clinical Trials Registry Platform (to 30 April 2020). We studied reference lists as well as published systematic review articles.

Selection Criteria: We included diagnostic accuracy study designs that compared a visual classification system (index test) with a reference standard (histology, excavation, radiographs). This included cross-sectional studies that evaluated the diagnostic accuracy of single index tests and studies that directly compared two or more index tests. Studies reporting at both the patient or tooth surface level were included. In vitro and in vivo studies were considered. Studies that explicitly recruited participants with caries into dentine or frank cavitation were excluded. We also excluded studies that artificially created carious lesions and those that used an index test during the excavation of dental caries to ascertain the optimum depth of excavation.

Data Collection And Analysis: We extracted data independently and in duplicate using a standardised data extraction and quality assessment form based on QUADAS-2 specific to the review context. Estimates of diagnostic accuracy were determined using the bivariate hierarchical method to produce summary points of sensitivity and specificity with 95% confidence intervals (CIs) and regions, and 95% prediction regions. The comparative accuracy of different classification systems was conducted based on indirect comparisons. Potential sources of heterogeneity were pre-specified and explored visually and more formally through meta-regression.

Main Results: We included 71 datasets from 67 studies (48 completed in vitro) reporting a total of 19,590 tooth sites/surfaces. The most frequently reported classification systems were the International Caries Detection and Assessment System (ICDAS) (36 studies) and Ekstrand-Ricketts-Kidd (ERK) (15 studies). In reporting the results, no distinction was made between detection and diagnosis. Only two studies were at low risk of bias across all four domains, and 15 studies were at low concern for applicability across all three domains. The patient selection domain had the highest proportion of high risk of bias studies (49 studies). Four studies were assessed at high risk of bias for the index test domain, nine for the reference standard domain, and seven for the flow and timing domain. Due to the high number of studies on extracted teeth concerns regarding applicability were high for the patient selection and index test domains (49 and 46 studies respectively). Studies were synthesised using a hierarchical bivariate method for meta-analysis. There was substantial variability in the results of the individual studies: sensitivities ranged from 0.16 to 1.00 and specificities from 0 to 1.00. For all visual classification systems the estimated summary sensitivity and specificity point was 0.86 (95% CI 0.80 to 0.90) and 0.77 (95% CI 0.72 to 0.82) respectively, diagnostic odds ratio (DOR) 20.38 (95% CI 14.33 to 28.98). In a cohort of 1000 tooth surfaces with 28% prevalence of enamel caries, this would result in 40 being classified as disease free when enamel caries was truly present (false negatives), and 163 being classified as diseased in the absence of enamel caries (false positives). The addition of test type to the model did not result in any meaningful difference to the sensitivity or specificity estimates (Chi(4) = 3.78, P = 0.44), nor did the addition of primary or permanent dentition (Chi(2) = 0.90, P = 0.64). The variability of results could not be explained by tooth surface (occlusal or approximal), prevalence of dentinal caries in the sample, nor reference standard. Only one study intentionally included restored teeth in its sample and no studies reported the inclusion of sealants. We rated the certainty of the evidence as low, and downgraded two levels in total for risk of bias due to limitations in the design and conduct of the included studies, indirectness arising from the in vitro studies, and inconsistency of results.

Authors' Conclusions: Whilst the confidence intervals for the summary points of the different visual classification systems indicated reasonable performance, they do not reflect the confidence that one can have in the accuracy of assessment using these systems due to the considerable unexplained heterogeneity evident across the studies. The prediction regions in which the sensitivity and specificity of a future study should lie are very broad, an important consideration when interpreting the results of this review. Should treatment be provided as a consequence of a false-positive result then this would be non-invasive, typically the application of fluoride varnish where it was not required, with low potential for an adverse event but healthcare resource and finance costs. Despite the robust methodology applied in this comprehensive review, the results should be interpreted with some caution due to shortcomings in the design and execution of many of the included studies. Studies to determine the diagnostic accuracy of methods to detect and diagnose caries in situ are particularly challenging. Wherever possible future studies should be carried out in a clinical setting, to provide a realistic assessment of performance within the oral cavity with the challenges of plaque, tooth staining, and restorations, and consider methods to minimise bias arising from the use of imperfect reference standards in clinical studies.
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http://dx.doi.org/10.1002/14651858.CD014546DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8428329PMC
June 2021

Electrical conductance for the detection of dental caries.

Cochrane Database Syst Rev 2021 03 16;3:CD014547. Epub 2021 Mar 16.

Dundee Dental School, University of Dundee, Dundee, UK.

Background: Caries is one of the most prevalent, preventable conditions worldwide. A wide variety of management options are available at different thresholds of disease, ranging from non-operative preventive strategies such as improved oral hygiene, reduced sugar diet, and application of topical fluoride, to minimally invasive treatments for early lesions which are limited to enamel, through to selective removal and restoration for extensive lesions. The cornerstone of caries detection is a visual and tactile dental examination, however, an increasing array of methods of caries lesion detection have been proposed that could potentially support traditional methods of detection and diagnosis. Earlier identification of disease could afford patients the opportunity of less invasive treatment with less destruction of tooth tissue, reduce the need for treatment with aerosol-generating procedures, and potentially result in a reduced cost of care to the patient and to healthcare services.

Objectives: Our primary objective was to determine the diagnostic accuracy of different electrical conductance devices for the detection and diagnosis of non-cavitated coronal dental caries in different populations (children, adolescents, and adults) and when tested against different reference standards.

Search Methods: Cochrane Oral Health's Information Specialist undertook a search of the following databases: MEDLINE Ovid (1946 to 26 April 2019); Embase Ovid (1980 to 26 April 2019); US National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov, to 26 April 2019); and the World Health Organization International Clinical Trials Registry Platform (to 26 April 2019). We studied reference lists as well as published systematic review articles.

Selection Criteria: We included diagnostic accuracy studies that compared electrical conductance devices with a reference standard of histology or an enhanced visual examination. This included prospective studies that evaluated the diagnostic accuracy of single index tests and studies that directly compared two or more index tests. We included studies using previously extracted teeth or those that recruited participants with teeth believed to be sound or with early lesions limited to enamel. Studies that explicitly recruited participants with more advanced lesions that were obviously into dentine or frankly cavitated were excluded.

Data Collection And Analysis: Two review authors extracted data independently using a piloted study data extraction form based on the Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2). Sensitivity and specificity with 95% confidence intervals (CIs) were reported for each study. This information was displayed as coupled forest plots, and plotted as summary receiver operating characteristic (SROC) plots, displaying the sensitivity-specificity points for each study. Due to variability in thresholds we estimated diagnostic accuracy using hierarchical summary receiver operating characteristic (HSROC) methods.

Main Results: We included seven studies reporting a total of 719 tooth sites or surfaces, with an overall prevalence of the target condition of 73% (528 tooth sites or surfaces). The included studies evaluated two index tests: the electronic caries monitor (ECM) (four studies, 475 tooth surfaces) and CarieScan Pro (three studies, 244 tooth surfaces). Six studies used histology as the reference standard, one used an enhanced visual examination. No study was considered to be at low risk of bias across all four domains or low concern for applicability or both. All studies were at high (five studies) or unclear (two studies) risk of bias for the patient selection domain. We judged two studies to be at unclear risk of bias for the index test domain, and one study to be at high risk of bias for the reference standard and flow and timing domains. We judged three studies to be at low concern for applicability for patient selection, and all seven studies to be of low concern for reference standard and flow and timing domains. Studies were synthesised using a hierarchical method for meta-analysis. There was variability in the results of the individual studies, with sensitivities which ranged from 0.55 to 0.98 and specificities from 0 to 1.00. These extreme values of specificity may be explained by a low number of healthy tooth surfaces in the included samples. The diagnostic odds ratio (DOR) was 15.65 (95% CI 1.43 to 171.15), and indicative of the variability in the included studies. Through meta-regression we observed no meaningful difference in accuracy according to device type or dentition. Due to the small number of studies we were unable to formally investigate other potential sources of heterogeneity. We judged the certainty of the evidence as very low, and downgraded for risk of bias due to limitations in the design and conduct of the included studies, imprecision arising from the relatively small number of surfaces studied, and inconsistency due to the variability of results.

Authors' Conclusions: The design and conduct of studies to determine the diagnostic accuracy of methods to detect and diagnose caries in situ is particularly challenging. The evidence base to support the detection and diagnosis of caries with electrical conductance devices is sparse. Newer electrical conductance devices show promise and further research at the enamel caries threshold using a robust study design to minimise bias is warranted. In terms of applicability, any future studies should be carried out in a clinical setting to provide a realistic assessment within the oral cavity where plaque, staining, and restorations can be problematic.
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http://dx.doi.org/10.1002/14651858.CD014547DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8406820PMC
March 2021

Imaging modalities to inform the detection and diagnosis of early caries.

Cochrane Database Syst Rev 2021 03 15;3:CD014545. Epub 2021 Mar 15.

Division of Dentistry, School of Medical Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK.

Background: The detection and diagnosis of caries at the earliest opportunity is fundamental to the preservation of tooth tissue and maintenance of oral health. Radiographs have traditionally been used to supplement the conventional visual-tactile clinical examination. Accurate, timely detection and diagnosis of early signs of disease could afford patients the opportunity of less invasive treatment with less destruction of tooth tissue, reduce the need for treatment with aerosol-generating procedures, and potentially result in a reduced cost of care to the patient and to healthcare services.

Objectives: To determine the diagnostic accuracy of different dental imaging methods to inform the detection and diagnosis of non-cavitated enamel only coronal dental caries.

Search Methods: Cochrane Oral Health's Information Specialist undertook a search of the following databases: MEDLINE Ovid (1946 to 31 December 2018); Embase Ovid (1980 to 31 December 2018); US National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov, to 31 December 2018); and the World Health Organization International Clinical Trials Registry Platform (to 31 December 2018). We studied reference lists as well as published systematic review articles.

Selection Criteria: We included diagnostic accuracy study designs that compared a dental imaging method with a reference standard (histology, excavation, enhanced visual examination), studies that evaluated the diagnostic accuracy of single index tests, and studies that directly compared two or more index tests. Studies reporting at both the patient or tooth surface level were included. In vitro and in vivo studies were eligible for inclusion. Studies that explicitly recruited participants with more advanced lesions that were obviously into dentine or frankly cavitated were excluded. We also excluded studies that artificially created carious lesions and those that used an index test during the excavation of dental caries to ascertain the optimum depth of excavation.

Data Collection And Analysis: Two review authors extracted data independently and in duplicate using a standardised data extraction form and quality assessment based on QUADAS-2 specific to the clinical context. Estimates of diagnostic accuracy were determined using the bivariate hierarchical method to produce summary points of sensitivity and specificity with 95% confidence regions. Comparative accuracy of different radiograph methods was conducted based on indirect and direct comparisons between methods. Potential sources of heterogeneity were pre-specified and explored visually and more formally through meta-regression.

Main Results: We included 104 datasets from 77 studies reporting a total of 15,518 tooth sites or surfaces. The most frequently reported imaging methods were analogue radiographs (55 datasets from 51 studies) and digital radiographs (42 datasets from 40 studies) followed by cone beam computed tomography (CBCT) (7 datasets from 7 studies). Only 17 studies were of an in vivo study design, carried out in a clinical setting. No studies were considered to be at low risk of bias across all four domains but 16 studies were judged to have low concern for applicability across all domains. The patient selection domain had the largest number of studies judged to be at high risk of bias (43 studies); the index test, reference standard, and flow and timing domains were judged to be at high risk of bias in 30, 12, and 7 studies respectively. Studies were synthesised using a hierarchical bivariate method for meta-analysis. There was substantial variability in the results of the individual studies, with sensitivities that ranged from 0 to 0.96 and specificities from 0 to 1.00. For all imaging methods the estimated summary sensitivity and specificity point was 0.47 (95% confidence interval (CI) 0.40 to 0.53) and 0.88 (95% CI 0.84 to 0.92), respectively. In a cohort of 1000 tooth surfaces with a prevalence of enamel caries of 63%, this would result in 337 tooth surfaces being classified as disease free when enamel caries was truly present (false negatives), and 43 tooth surfaces being classified as diseased in the absence of enamel caries (false positives). Meta-regression indicated that measures of accuracy differed according to the imaging method (Chi(4) = 32.44, P < 0.001), with the highest sensitivity observed for CBCT, and the highest specificity observed for analogue radiographs. None of the specified potential sources of heterogeneity were able to explain the variability in results. No studies included restored teeth in their sample or reported the inclusion of sealants. We rated the certainty of the evidence as low for sensitivity and specificity and downgraded two levels in total for risk of bias due to limitations in the design and conduct of the included studies, indirectness arising from the in vitro studies, and the observed inconsistency of the results.

Authors' Conclusions: The design and conduct of studies to determine the diagnostic accuracy of methods to detect and diagnose caries in situ are particularly challenging. Low-certainty evidence suggests that imaging for the detection or diagnosis of early caries may have poor sensitivity but acceptable specificity, resulting in a relatively high number of false-negative results with the potential for early disease to progress. If left untreated, the opportunity to provide professional or self-care practices to arrest or reverse early caries lesions will be missed. The specificity of lesion detection is however relatively high, and one could argue that initiation of non-invasive management (such as the use of topical fluoride), is probably of low risk. CBCT showed superior sensitivity to analogue or digital radiographs but has very limited applicability to the general dental practitioner. However, given the high-radiation dose, and potential for caries-like artefacts from existing restorations, its use cannot be justified in routine caries detection. Nonetheless, if early incidental carious lesions are detected in CBCT scans taken for other purposes, these should be reported. CBCT has the potential to be used as a reference standard in diagnostic studies of this type. Despite the robust methodology applied in this comprehensive review, the results should be interpreted with some caution due to shortcomings in the design and execution of many of the included studies. Future research should evaluate the comparative accuracy of different methods, be undertaken in a clinical setting, and focus on minimising bias arising from the use of imperfect reference standards in clinical studies.
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http://dx.doi.org/10.1002/14651858.CD014545DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8441255PMC
March 2021

Examining the effectiveness of different dental recall strategies on maintenance of optimum oral health: the INTERVAL dental recalls randomised controlled trial.

Br Dent J 2021 Feb 26;230(4):236-243. Epub 2021 Feb 26.

Professor, Dundee Dental Hospital & School, University of Dundee, Dundee, UK.

Objective To compare the clinical effectiveness of different frequencies of dental recall over a four-year period.Design A multi-centre, parallel-group, randomised controlled trial with blinded clinical outcome assessment. Participants were randomised to receive a dental check-up at six-monthly, 24-monthly or risk-based recall intervals. A two-strata trial design was used, with participants randomised within the 24-month stratum if the recruiting dentist considered them clinically suitable. Participants ineligible for 24-month recall were randomised to a risk-based or six-month recall interval.Setting UK primary dental care.Participants Practices providing NHS care and adults who had received regular dental check-ups.Main outcome measures The percentage of sites with gingival bleeding on probing, oral health-related quality of life (OHRQoL), cost-effectiveness.Results In total, 2,372 participants were recruited from 51 dental practices. Of those, 648 were eligible for the 24-month recall stratum and 1,724 participants were ineligible. There was no evidence of a significant difference in the mean percentage of sites with gingival bleeding on probing between intervention arms in any comparison. For those eligible for 24-month recall stratum: the 24-month versus six-month group had an adjusted mean difference of -0.91%, 95% CI (-5.02%, 3.20%); the 24-month group versus risk-based group had an adjusted mean difference of 0.07%, 95% CI (-3.99%, 4.12%). For the overall sample, the risk-based versus six-month adjusted mean difference was 0.78%, 95% CI (-1.17%, 2.72%). There was no evidence of a difference in OHRQoL (0-56 scale, higher score for poorer OHRQoL) between intervention arms in any comparison. For the overall sample, the risk-based versus six-month effect size was -0.35, 95% CI (-1.02, 0.32). There was no evidence of a clinically meaningful difference between the groups in any comparison in either eligibility stratum for any of the secondary clinical or patient-reported outcomes.Conclusion Over a four-year period, we found no evidence of a difference in oral health for participants allocated to a six-month or a risk-based recall interval, nor between a 24-month, six-month or risk-based recall interval for participants eligible for a 24-month recall. However, patients greatly value and are willing to pay for frequent dental check-ups.
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http://dx.doi.org/10.1038/s41415-021-2612-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7908962PMC
February 2021

Transillumination and optical coherence tomography for the detection and diagnosis of enamel caries.

Cochrane Database Syst Rev 2021 01 27;1:CD013855. Epub 2021 Jan 27.

Dundee Dental School, University of Dundee, Dundee, UK.

Background: Caries is one of the most prevalent and preventable conditions worldwide. If identified early enough then non-invasive techniques can be applied, and therefore this review focusses on early caries involving the enamel surface of the tooth. The cornerstone of caries detection and diagnosis is a visual and tactile dental examination, although alternative approaches are available. These include illumination-based devices that could potentially support the dental examination. There are three categories of illumination devices that exploit various methods of application and interpretation, each primarily defined by different wavelengths, optical coherence tomography (OCT), near-infrared (NIR), and fibre-optic technology, which incorporates more recently developed digital fibre optics (FOTI/DIFOTI).

Objectives: To estimate the diagnostic test accuracy of different illumination tests for the detection and diagnosis of enamel caries in children or adults. We also planned to explore the following potential sources of heterogeneity: in vitro or in vivo studies with different reference standards; tooth surface (occlusal, proximal, smooth surface, or adjacent to a restoration); single or multiple sites of assessment on a tooth surface; and the prevalence of caries into dentine.

Search Methods: Cochrane Oral Health's Information Specialist undertook a search of the following databases: MEDLINE Ovid (1946 to 15 February 2019); Embase Ovid (1980 to 15 February 2019); US National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov, to 15 February 2019); and the World Health Organization International Clinical Trials Registry Platform (to 15 February 2019). We studied reference lists as well as published systematic review articles.

Selection Criteria: We included diagnostic accuracy study designs that compared the use of illumination-based devices with a reference standard (histology, enhanced visual examination with or without radiographs, or operative excavation). These included prospective studies that evaluated the diagnostic accuracy of a single index test and studies that directly compared two or more index tests. Both in vitro and in vivo studies of primary and permanent teeth were eligible for inclusion. We excluded studies that explicitly recruited participants with caries into dentine or frank cavitation. We also excluded studies that artificially created carious lesions and those that used an index test during the excavation of dental caries to ascertain the optimum depth of excavation.

Data Collection And Analysis: Two review authors extracted data independently and in duplicate using a standardised data extraction form and quality assessment based on QUADAS-2 specific to the clinical context. Estimates of diagnostic accuracy were determined using the bivariate hierarchical method to produce summary points of sensitivity and specificity with 95% confidence regions. The comparative accuracy of different illumination devices was conducted based on indirect and direct comparisons between methods. Potential sources of heterogeneity were pre-specified and explored visually and more formally through meta-regression.

Main Results: We included 24 datasets from 23 studies that evaluated 16,702 tooth surfaces. NIR was evaluated in 6 datasets (673 tooth surfaces), OCT in 10 datasets (1171 tooth surfaces), and FOTI/DIFOTI in 8 datasets (14,858 tooth surfaces). The participant selection domain had the largest number of studies judged at high risk of bias (16 studies). Conversely, for the index test, reference standard, and flow and timing domains the majority of studies were judged to be at low risk of bias (16, 12, and 16 studies respectively). Concerns regarding the applicability of the evidence were judged as high or unclear for all domains. Notably, 14 studies were judged to be of high concern for participant selection, due to selective participant recruitment, a lack of independent examiners, and the use of an in vitro study design. The summary estimate across all the included illumination devices was sensitivity 0.75 (95% confidence interval (CI) 0.62 to 0.85) and specificity 0.87 (95% CI 0.82 to 0.92), with a diagnostic odds ratio of 21.52 (95% CI 10.89 to 42.48). In a cohort of 1000 tooth surfaces with a prevalence of enamel caries of 57%, this would result in 142 tooth surfaces being classified as disease free when enamel caries was truly present (false negatives), and 56 tooth surfaces being classified as diseased in the absence of enamel caries (false positives). A formal comparison of the accuracy according to device type indicated a difference in sensitivity and/or specificity (Chi(4) = 34.17, P < 0.01). Further analysis indicated a difference in the sensitivity of the different devices (Chi(2) = 31.24, P < 0.01) with a higher sensitivity of 0.94 (95% CI 0.88 to 0.97) for OCT compared to NIR 0.58 (95% CI 0.46 to 0.68) and FOTI/DIFOTI 0.47 (95% CI 0.35 to 0.59), but no meaningful difference in specificity (Chi(2) = 3.47, P = 0.18). In light of these results, we planned to formally assess potential sources of heterogeneity according to device type, but due to the limited number of studies for each device type we were unable to do so. For interpretation, we presented the coupled forest plots for each device type according to the potential source of heterogeneity. We rated the certainty of the evidence as low and downgraded two levels in total due to avoidable and unavoidable study limitations in the design and conduct of studies, indirectness arising from the in vitro studies, and imprecision of the estimates.

Authors' Conclusions: Of the devices evaluated, OCT appears to show the most potential, with superior sensitivity to NIR and fibre-optic devices. Its benefit lies as an add-on tool to support the conventional oral examination to confirm borderline cases in cases of clinical uncertainty. OCT is not currently available to the general dental practitioner, and so further research and development are necessary. FOTI and NIR are more readily available and easy to use; however, they show limitations in their ability to detect enamel caries but may be considered successful in the identification of sound teeth. Future studies should strive to avoid research waste by ensuring that recruitment is conducted in such a way as to minimise selection bias and that studies are clearly and comprehensively reported. In terms of applicability, any future studies should be undertaken in a clinical setting that is reflective of the complexities encountered in caries assessment within the oral cavity.
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http://dx.doi.org/10.1002/14651858.CD013855DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8487162PMC
January 2021

Oral hygiene care for critically ill patients to prevent ventilator-associated pneumonia.

Cochrane Database Syst Rev 2020 12 24;12:CD008367. Epub 2020 Dec 24.

Hubei-MOST KLOS & KLOBM, School and Hospital of Stomatology, Wuhan University, Wuhan, China.

Background: Ventilator-associated pneumonia (VAP) is defined as pneumonia developing in people who have received mechanical ventilation for at least 48 hours. VAP is a potentially serious complication in these patients who are already critically ill. Oral hygiene care (OHC), using either a mouthrinse, gel, swab, toothbrush, or combination, together with suction of secretions, may reduce the risk of VAP in these patients.

Objectives: To assess the effects of oral hygiene care (OHC) on incidence of ventilator-associated pneumonia in critically ill patients receiving mechanical ventilation in hospital intensive care units (ICUs).

Search Methods: Cochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 25 February 2020), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2020, Issue 1), MEDLINE Ovid (1946 to 25 February 2020), Embase Ovid (1980 to 25 February 2020), LILACS BIREME Virtual Health Library (1982 to 25 February 2020) and CINAHL EBSCO (1937 to 25 February 2020). We also searched the VIP Database (January 2012 to 8 March 2020). The US National Institutes of Health Trials Registry (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials. No restrictions were placed on the language or date of publication when searching the electronic databases.

Selection Criteria: We included randomised controlled trials (RCTs) evaluating the effects of OHC (mouthrinse, gel, swab, toothbrush or combination) in critically ill patients receiving mechanical ventilation for at least 48 hours.

Data Collection And Analysis: At least two review authors independently assessed search results, extracted data and assessed risk of bias in included studies. We contacted study authors for additional information. We reported risk ratio (RR) for dichotomous outcomes and mean difference (MD) for continuous outcomes, using the random-effects model of meta-analysis when data from four or more trials were combined.

Main Results: We included 40 RCTs (5675 participants), which were conducted in various countries including China, USA, Brazil and Iran. We categorised these RCTs into five main comparisons: chlorhexidine (CHX) mouthrinse or gel versus placebo/usual care; CHX mouthrinse versus other oral care agents; toothbrushing (± antiseptics) versus no toothbrushing (± antiseptics); powered versus manual toothbrushing; and comparisons of other oral care agents used in OHC (other oral care agents versus placebo/usual care, or head-to-head comparisons between other oral care agents). We assessed the overall risk of bias as high in 31 trials and low in two, with the rest being unclear. Moderate-certainty evidence from 13 RCTs (1206 participants, 92% adults) shows that CHX mouthrinse or gel, as part of OHC, probably reduces the incidence of VAP compared to placebo or usual care from 26% to about 18% (RR 0.67, 95% confidence intervals (CI) 0.47 to 0.97; P = 0.03; I = 66%). This is equivalent to a number needed to treat for an additional beneficial outcome (NNTB) of 12 (95% CI 7 to 128), i.e. providing OHC including CHX for 12 ventilated patients in intensive care would prevent one patient developing VAP. There was no evidence of a difference between interventions for the outcomes of mortality (RR 1.03, 95% CI 0.80 to 1.33; P = 0.86, I = 0%; 9 RCTs, 944 participants; moderate-certainty evidence), duration of mechanical ventilation (MD -1.10 days, 95% CI -3.20 to 1.00 days; P = 0.30, I = 74%; 4 RCTs, 594 participants; very low-certainty evidence) or duration of intensive care unit (ICU) stay (MD -0.89 days, 95% CI -3.59 to 1.82 days; P = 0.52, I = 69%; 5 RCTs, 627 participants; low-certainty evidence). Most studies did not mention adverse effects. One study reported adverse effects, which were mild, with similar frequency in CHX and control groups and one study reported there were no adverse effects. Toothbrushing (± antiseptics) may reduce the incidence of VAP (RR 0.61, 95% CI 0.41 to 0.91; P = 0.01, I = 40%; 5 RCTs, 910 participants; low-certainty evidence) compared to OHC without toothbrushing (± antiseptics). There is also some evidence that toothbrushing may reduce the duration of ICU stay (MD -1.89 days, 95% CI -3.52 to -0.27 days; P = 0.02, I = 0%; 3 RCTs, 749 participants), but this is very low certainty. Low-certainty evidence did not show a reduction in mortality (RR 0.84, 95% CI 0.67 to 1.05; P = 0.12, I = 0%; 5 RCTs, 910 participants) or duration of mechanical ventilation (MD -0.43, 95% CI -1.17 to 0.30; P = 0.25, I = 46%; 4 RCTs, 810 participants).

Authors' Conclusions: Chlorhexidine mouthwash or gel, as part of OHC, probably reduces the incidence of developing ventilator-associated pneumonia (VAP) in critically ill patients from 26% to about 18%, when compared to placebo or usual care. We did not find a difference in mortality, duration of mechanical ventilation or duration of stay in the intensive care unit, although the evidence was low certainty. OHC including both antiseptics and toothbrushing may be more effective than OHC with antiseptics alone to reduce the incidence of VAP and the length of ICU stay, but, again, the evidence is low certainty. There is insufficient evidence to determine whether any of the interventions evaluated in the studies are associated with adverse effects.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8111488PMC
December 2020

Fluorescence devices for the detection of dental caries.

Cochrane Database Syst Rev 2020 12 8;12:CD013811. Epub 2020 Dec 8.

Dundee Dental School, University of Dundee, Dundee, UK.

Background: Caries is one of the most prevalent and preventable conditions worldwide. If identified early enough then non-invasive techniques can be applied, and therefore this review focusses on early caries involving the enamel surface of the tooth. The cornerstone of caries detection is a visual and tactile dental examination, however alternative methods of detection are available, and these include fluorescence-based devices. There are three categories of fluorescence-based device each primarily defined by the different wavelengths they exploit; we have labelled these groups as red, blue, and green fluorescence. These devices could support the visual examination for the detection and diagnosis of caries at an early stage of decay.

Objectives: Our primary objectives were to estimate the diagnostic test accuracy of fluorescence-based devices for the detection and diagnosis of enamel caries in children or adults. We planned to investigate the following potential sources of heterogeneity: tooth surface (occlusal, proximal, smooth surface or adjacent to a restoration); single point measurement devices versus imaging or surface assessment devices; and the prevalence of more severe disease in each study sample, at the level of caries into dentine.

Search Methods: Cochrane Oral Health's Information Specialist undertook a search of the following databases: MEDLINE Ovid (1946 to 30 May 2019); Embase Ovid (1980 to 30 May 2019); US National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov, to 30 May 2019); and the World Health Organization International Clinical Trials Registry Platform (to 30 May 2019). We studied reference lists as well as published systematic review articles.

Selection Criteria: We included diagnostic accuracy study designs that compared a fluorescence-based device with a reference standard. This included prospective studies that evaluated the diagnostic accuracy of single index tests and studies that directly compared two or more index tests. Studies that explicitly recruited participants with caries into dentine or frank cavitation were excluded.

Data Collection And Analysis: Two review authors extracted data independently using a piloted study data extraction form based on the Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2). Sensitivity and specificity with 95% confidence intervals (CIs) were reported for each study. This information has been displayed as coupled forest plots and summary receiver operating characteristic (SROC) plots, displaying the sensitivity-specificity points for each study. We estimated diagnostic accuracy using hierarchical summary receiver operating characteristic (HSROC) methods. We reported sensitivities at fixed values of specificity (median 0.78, upper quartile 0.90).

Main Results: We included a total of 133 studies, 55 did not report data in the 2 x 2 format and could not be included in the meta-analysis. 79 studies which provided 114 datasets and evaluated 21,283 tooth surfaces were included in the meta-analysis. There was a high risk of bias for the participant selection domain. The index test, reference standard, and flow and timing domains all showed a high proportion of studies to be at low risk of bias. Concerns regarding the applicability of the evidence were high or unclear for all domains, the highest proportion being seen in participant selection. Selective participant recruitment, poorly defined diagnostic thresholds, and in vitro studies being non-generalisable to the clinical scenario of a routine dental examination were the main reasons for these findings. The dominance of in vitro studies also means that the information on how the results of these devices are used to support diagnosis, as opposed to pure detection, was extremely limited. There was substantial variability in the results which could not be explained by the different devices or dentition or other sources of heterogeneity that we investigated. The diagnostic odds ratio (DOR) was 14.12 (95% CI 11.17 to 17.84). The estimated sensitivity, at a fixed median specificity of 0.78, was 0.70 (95% CI 0.64 to 0.75). In a hypothetical cohort of 1000 tooth sites or surfaces, with a prevalence of enamel caries of 57%, obtained from the included studies, the estimated sensitivity of 0.70 and specificity of 0.78 would result in 171 missed tooth sites or surfaces with enamel caries (false negatives) and 95 incorrectly classed as having early caries (false positives). We used meta-regression to compare the accuracy of the different devices for red fluorescence (84 datasets, 14,514 tooth sites), blue fluorescence (21 datasets, 3429 tooth sites), and green fluorescence (9 datasets, 3340 tooth sites) devices. Initially, we allowed threshold, shape, and accuracy to vary according to device type by including covariates in the model. Allowing consistency of shape, removal of the covariates for accuracy had only a negligible effect (Chi = 3.91, degrees of freedom (df) = 2, P = 0.14). Despite the relatively large volume of evidence we rated the certainty of the evidence as low, downgraded two levels in total, for risk of bias due to limitations in the design and conduct of the included studies, indirectness arising from the high number of in vitro studies, and inconsistency due to the substantial variability of results.

Authors' Conclusions: There is considerable variation in the performance of these fluorescence-based devices that could not be explained by the different wavelengths of the devices assessed, participant, or study characteristics. Blue and green fluorescence-based devices appeared to outperform red fluorescence-based devices but this difference was not supported by the results of a formal statistical comparison. The evidence base was considerable, but we were only able to include 79 studies out of 133 in the meta-analysis as estimates of sensitivity or specificity values or both could not be extracted or derived. In terms of applicability, any future studies should be carried out in a clinical setting, where difficulties of caries assessment within the oral cavity include plaque, staining, and restorations. Other considerations include the potential of fluorescence devices to be used in combination with other technologies and comparative diagnostic accuracy studies.
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December 2020

Risk-based, 6-monthly and 24-monthly dental check-ups for adults: the INTERVAL three-arm RCT.

Health Technol Assess 2020 11;24(60):1-138

Dental Health Services Research Unit, University of Dundee, Dundee, UK.

Background: Traditionally, patients are encouraged to attend dental recall appointments at regular 6-month intervals, irrespective of their risk of developing dental disease. Stakeholders lack evidence of the relative effectiveness and cost-effectiveness of different recall strategies and the optimal recall interval for maintenance of oral health.

Objectives: To test effectiveness and assess the cost-benefit of different dental recall intervals over a 4-year period.

Design: Multicentre, parallel-group, randomised controlled trial with blinded clinical outcome assessment at 4 years and a within-trial cost-benefit analysis. NHS and participant perspective costs were combined with benefits estimated from a general population discrete choice experiment. A two-stratum trial design was used, with participants randomised to the 24-month interval if the recruiting dentist considered them clinically suitable. Participants ineligible for 24-month recall were randomised to a risk-based or 6-month recall interval.

Setting: UK primary care dental practices.

Participants: Adult, dentate, NHS patients who had visited their dentist in the previous 2 years.

Interventions: Participants were randomised to attend for a dental check-up at one of three dental recall intervals: 6-month, risk-based or 24-month recall.

Main Outcomes: Clinical - gingival bleeding on probing; patient - oral health-related quality of life; economic - three analysis frameworks: (1) incremental cost per quality-adjusted life-year gained, (2) incremental net (societal) benefit and (3) incremental net (dental health) benefit.

Results: A total of 2372 participants were recruited from 51 dental practices; 648 participants were eligible for the 24-month recall stratum and 1724 participants were ineligible. There was no evidence of a significant difference in the mean percentage of sites with gingival bleeding between intervention arms in any comparison. For the eligible for 24-month recall stratum: the 24-month ( = 138) versus 6-month group ( = 135) had an adjusted mean difference of -0.91 (95% confidence interval -5.02 to 3.20); the risk-based ( = 143) versus 6-month group had an adjusted mean difference of -0.98 (95% confidence interval -5.05 to 3.09); the 24-month versus risk-based group had an adjusted mean difference of 0.07 (95% confidence interval -3.99 to 4.12). For the overall sample, the risk-based ( = 749) versus 6-month ( = 737) adjusted mean difference was 0.78 (95% confidence interval -1.17 to 2.72). There was no evidence of a difference in oral health-related quality of life between intervention arms in any comparison. For the economic evaluation, under framework 1 (cost per quality-adjusted life-year) the results were highly uncertain, and it was not possible to identify the optimal recall strategy. Under framework 2 (net societal benefit), 6-month recalls were the most efficient strategy with a probability of positive net benefit ranging from 78% to 100% across the eligible and combined strata, with findings driven by the high value placed on more frequent recall services in the discrete choice experiment. Under framework 3 (net dental health benefit), 24-month recalls were the most likely strategy to deliver positive net (dental health) benefit among those eligible for 24-month recall, with a probability of positive net benefit ranging from 65% to 99%. For the combined group, the optimal strategy was less clear. Risk-based recalls were more likely to be the most efficient recall strategy in scenarios where the costing perspective was widened to include participant-incurred costs, and in the Scottish subgroup.

Limitations: Information regarding factors considered by dentists to inform the risk-based interval and the interaction with patients to determine risk and agree the interval were not collected.

Conclusions: Over a 4-year period, we found no evidence of a difference in oral health for participants allocated to a 6-month or a risk-based recall interval, nor between a 24-month, 6-month or risk-based recall interval for participants eligible for a 24-month recall. However, people greatly value and are willing to pay for frequent dental check-ups; therefore, the most efficient recall strategy depends on the scope of the cost and benefit valuation that decision-makers wish to consider.

Future Work: Assessment of the impact of risk assessment tools in informing risk-based interval decision-making and techniques for communicating a variable recall interval to patients.

Trial Registration: Current Controlled Trials ISRCTN95933794.

Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme [project numbers 06/35/05 (Phase I) and 06/35/99 (Phase II)] and will be published in full in ; Vol. 24, No. 60. See the NIHR Journals Library website for further project information.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7701991PMC
November 2020

Pit and fissure sealants versus fluoride varnishes for preventing dental decay in the permanent teeth of children and adolescents.

Cochrane Database Syst Rev 2020 11 4;11:CD003067. Epub 2020 Nov 4.

Health Economics Research Unit, University of Aberdeen, Aberdeen, UK.

Background: Most of the detected increment in dental caries among children above the age of six years and adolescents is confined to occlusal surfaces of posterior permanent molars. Dental sealants and fluoride varnishes are much used to prevent caries. As the effectiveness of both interventions in controlling caries as compared with no intervention has been demonstrated previously, this review aimed to evaluate their relative effectiveness. It updates a review published originally in 2006 and updated in 2010 and in 2016.

Objectives: Our primary objective was to evaluate the relative effectiveness of dental sealants (i.e. fissure sealant) compared with fluoride varnishes, or fissure sealants plus fluoride varnishes compared with fluoride varnishes alone, for preventing dental caries in the occlusal surfaces of permanent teeth of children and adolescents. Our secondary objectives were to evaluate whether effectiveness is influenced by sealant material type and length of follow-up, document and report on data concerning adverse events associated with sealants and fluoride varnishes, and report the cost effectiveness of dental sealants versus fluoride varnish in caries prevention.

Search Methods: Cochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 19 March 2020), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2020, Issue 2), MEDLINE Ovid (1946 to 19 March 2020) and Embase Ovid (1980 to 19 March 2020). We searched the US National Institutes of Health Trials Registry (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform for ongoing trials. There were no restrictions on the language or date of publication.

Selection Criteria: We included randomised controlled trials with at least 12 months of follow-up comparing fissure sealants, or fissure sealants plus fluoride varnishes, versus fluoride varnishes, for preventing caries in the occlusal surfaces of permanent posterior teeth (i.e. premolar or molar teeth), in participants younger than 20 years of age at the start of the study.

Data Collection And Analysis: At least two review authors independently screened search results, extracted data from included studies and assessed their risk of bias. We attempted to contact study authors to obtain missing or unclear information. We grouped and analysed studies on the basis of sealant material type: resin-based sealant or glass ionomer-based sealant (glass ionomer and resin-modified glass ionomer sealant), and different follow-up periods. We calculated the odds ratio (OR) for risk of caries on occlusal surfaces of permanent molar teeth. For trials with a split-mouth design, we used the Becker-Balagtas OR. One cluster-randomised trial provided precise estimates in terms of risk ratio (RR), which we used. For continuous outcomes and data, we used means and standard deviations to obtain mean differences (MD). For meta-analysis, we used the random-effects model when we combined data from four or more studies. We presented all measures with 95% confidence intervals (CIs). We assessed the certainty of the evidence using GRADE criteria.

Main Results: We included 11 trials with 3374 participants aged five to 10 years when trials started. Three trials are new since the 2016 update. Two trials did not contribute data to our analysis. Sealant versus fluoride varnish Resin-based fissure sealants versus fluoride varnishes Seven trials evaluated this comparison (five contributing data). We are uncertain if resin-based sealants may be better than fluoride varnish, or vice versa, for preventing caries in first permanent molars at two to three years' follow-up (OR 0.67, 95% CI 0.37 to 1.19; I = 84%; 4 studies, 1683 children evaluated). One study measuring decayed, missing and filled permanent surfaces (DMFS) and decayed, missing and filled permanent teeth (DMFT) increment at two years suggested a small benefit for fissure sealant (DMFS MD -0.09, 95% CI -0.15 to -0.03; DMFT MD -0.08, 95% CI -0.14 to -0.02; 542 participants), though this may not be clinically significant. One small study, at high risk of bias, reported a benefit for sealant after four years in preventing caries (RR 0.42, 95% CI 0.21 to 0.84; 75 children) and at nine years (RR 0.48, 95% CI 0.29 to 0.79; 75 children). We assessed each of these results as having very low certainty. Glass ionomer-based sealants versus fluoride varnishes Three trials evaluated this comparison: one trial with chemically cured glass ionomer and two with resin-modified glass ionomer. Studies were clinically diverse, so we did not conduct a meta-analysis. In general, the studies found no benefit of one intervention over another at one, two and three years, although one study, which also included oral health education, suggested a benefit from sealants over varnish for children at high risk of caries. We assessed this evidence as very low certainty. Sealant plus fluoride varnish versus fluoride varnish alone One split-mouth trial analysing 92 children at two-year follow-up found in favour of resin-based fissure sealant plus fluoride varnish over fluoride varnish only (OR 0.30, 95% CI 0.17 to 0.55), which represented a clinically meaningful effect of a 77% reduction in caries after two years; however, we assessed this evidence as very low certainty. Adverse events Five trials (1801 participants) (four using resin-based sealant material and one using resin-modified glass ionomer) reported that no adverse events resulted from use of sealants or fluoride varnishes over one to nine years. The other studies did not mention adverse events.

Authors' Conclusions: Applying fluoride varnish or resin-based fissure sealants to first permanent molars helps prevent occlusal caries, but it has not been possible in this review to reach reliable conclusions about which one is better to apply. The available studies do not suggest either intervention is superior, but we assessed this evidence as having very low certainty. We found very low-certainty evidence that placing resin-based sealant as well as applying fluoride varnish works better than applying fluoride varnish alone. Fourteen studies are currently ongoing and their findings may allow us to draw firmer conclusions about whether sealants and varnish work equally well or whether one is better than the other.
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November 2020

Recall intervals for oral health in primary care patients.

Cochrane Database Syst Rev 2020 10 14;10:CD004346. Epub 2020 Oct 14.

Department of Epidemiology and Public Health, University College Cork, Cork, Ireland.

Background: There is ongoing debate about the frequency with which patients should attend for a dental check-up and the effects on oral health of the interval between check-ups. Recommendations regarding optimal recall intervals vary between countries and dental healthcare systems, but 6-month dental check-ups have traditionally been advocated by general dental practitioners in many high-income countries. This review updates a version first published in 2005, and updated in 2007 and 2013.

Objectives: To determine the optimal recall interval of dental check-up for oral health in a primary care setting.

Search Methods: Cochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 17 January 2020), the Cochrane Central Register of Controlled Trials (CENTRAL; in the Cochrane Library, 2019, Issue 12), MEDLINE Ovid (1946 to 17 January 2020), and Embase Ovid (1980 to 17 January 2020). We also searched the US National Institutes of Health Trials Registry (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform for ongoing trials. We placed no restrictions on the language or date of publication when searching.

Selection Criteria: We included randomised controlled trials (RCTs) assessing the effects of different dental recall intervals in a primary care setting.

Data Collection And Analysis: Two review authors screened search results against inclusion criteria, extracted data and assessed risk of bias, independently and in duplicate. We contacted study authors for clarification or further information where necessary and feasible. We expressed the estimate of effect as mean difference (MD) with 95% confidence intervals (CIs) for continuous outcomes and risk ratios (RR) with 95% CIs for dichotomous outcomes. We assessed the certainty of the evidence using GRADE.

Main Results: We included two studies with data from 1736 participants. One study was conducted in a public dental service clinic in Norway and involved participants under 20 years of age who were regular attenders at dental appointments. It compared 12-month with 24-month recall intervals and measured outcomes at two years. The other study was conducted in UK general dental practices and involved adults who were regular attenders, which was defined as having attended the dentist at least once in the previous two years. It compared the effects of 6-month, 24-month and risk-based recall intervals, and measured outcomes at four years. The main outcomes we considered were dental caries, gingival bleeding and oral-health-related quality of life. Neither study measured other potential adverse effects. 24-month versus 12-month recall at 2 years' follow-up Due to the very low certainty of evidence from one trial, it is unclear if there is an important difference in caries experience between assignment to a 24-month or a 12-month recall. For 3- to 5-year-olds with primary teeth, the mean difference (MD) in dmfs (decayed, missing, and filled tooth surfaces) increment was 0.90 (95% CI -0.16 to 1.96; 58 participants). For 16- to 20-year-olds with permanent teeth, the MD in DMFS increment was 0.86 (95% CI -0.03 to 1.75; 127 participants). The trial did not assess other clinical outcomes of relevance to this review. Risk-based recall versus 6-month recall at 4 years' follow-up We found high-certainty evidence from one trial of adults that there is little to no difference between risk-based and 6-month recall intervals for the outcomes: number of tooth surfaces with any caries (ICDAS 1 to 6; MD 0.15, 95% CI -0.77 to 1.08; 1478 participants); proportion of sites with gingival bleeding (MD 0.78%, 95% CI -1.17% to 2.73%; 1472 participants); oral-health-related quality of life (MD in OHIP-14 scores -0.35, 95% CI -1.02 to 0.32; 1551 participants). There is probably little to no difference in the prevalence of moderate to extensive caries (ICDAS 3 to 6) between the groups (RR 1.04, 95% CI 0.99 to 1.09; 1478 participants; moderate-certainty evidence). 24-month recall versus 6-month recall at 4 years' follow-up We found moderate-certainty evidence from one trial of adults that there is probably little to no difference between 24-month and 6-month recall intervals for the outcomes: number of tooth surfaces with any caries (MD -0.60, 95% CI -2.54 to 1.34; 271 participants); percentage of sites with gingival bleeding (MD -0.91%, 95% CI -5.02% to 3.20%; 271 participants). There may be little to no difference between the groups in the prevalence of moderate to extensive caries (RR 1.05, 95% CI 0.92 to 1.20; 271 participants; low-certainty evidence). We found high-certainty evidence that there is little to no difference in oral-health-related quality of life between the groups (MD in OHIP-14 scores -0.24, 95% CI -1.55 to 1.07; 305 participants). Risk-based recall versus 24-month recall at 4 years' follow-up We found moderate-certainty evidence from one trial of adults that there is probably little to no difference between risk-based and 24-month recall intervals for the outcomes: prevalence of moderate to extensive caries (RR 1.06, 95% CI 0.95 to 1.19; 279 participants); number of tooth surfaces with any caries (MD 1.40, 95% CI -0.69 to 3.49; 279 participants). We found high-certainty evidence that there is no important difference between the groups in the percentage of sites with gingival bleeding (MD -0.07%, 95% CI -4.10% to 3.96%; 279 participants); or in oral-health-related quality of life (MD in OHIP-14 scores -0.37, 95% CI -1.69 to 0.95; 298 participants).

Authors' Conclusions: For adults attending dental check-ups in primary care settings, there is little to no difference between risk-based and 6-month recall intervals in the number of tooth surfaces with any caries, gingival bleeding and oral-health-related quality of life over a 4-year period (high-certainty evidence). There is probably little to no difference between the recall strategies in the prevalence of moderate to extensive caries (moderate-certainty evidence). When comparing 24-month with either 6-month or risk-based recall intervals for adults, there is moderate- to high-certainty evidence that there is little to no difference in the number of tooth surfaces with any caries, gingival bleeding and oral-health-related quality of life over a 4-year period. The available evidence on recall intervals between dental check-ups for children and adolescents is uncertain. The two trials we included in the review did not assess adverse effects of different recall strategies.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8256238PMC
October 2020

Use of antimicrobial mouthwashes (gargling) and nasal sprays by healthcare workers to protect them when treating patients with suspected or confirmed COVID-19 infection.

Cochrane Database Syst Rev 2020 09 16;9:CD013626. Epub 2020 Sep 16.

Cochrane Oral Health, Division of Dentistry, School of Medical Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK.

Background: COVID-19 infection poses a serious risk to patients and - due to its contagious nature - to those healthcare workers (HCWs) treating them. If the mouth and nose of HCWs are irrigated with antimicrobial solutions, this may help reduce the risk of active infection being passed from infected patients to HCWs through droplet transmission or direct contact. However, the use of such antimicrobial solutions may be associated with harms related to the toxicity of the solutions themselves, or alterations in the natural microbial flora of the mouth or nose. Understanding these possible side effects is particularly important when the HCWs are otherwise fit and well.

Objectives: To assess the benefits and harms of antimicrobial mouthwashes and nasal sprays used by healthcare workers (HCWs) to protect themselves when treating patients with suspected or confirmed COVID-19 infection.

Search Methods: Information Specialists from Cochrane ENT and Cochrane Oral Health searched the Central Register of Controlled Trials (CENTRAL 2020, Issue 6); Ovid MEDLINE; Ovid Embase and additional sources for published and unpublished trials. The date of the search was 1 June 2020.  SELECTION CRITERIA: This is a question that urgently requires evidence, however at the present time we did not anticipate finding many completed randomised controlled trials (RCTs). We therefore planned to include the following types of studies: RCTs; quasi-RCTs; non-randomised controlled trials; prospective cohort studies; retrospective cohort studies; cross-sectional studies; controlled before-and-after studies. We set no minimum duration for the studies.   We sought studies comparing any antimicrobial mouthwash and/or nasal spray (alone or in combination) at any concentration, delivered to HCWs, with or without the same intervention being given to the patients with COVID-19.

Data Collection And Analysis: We used standard Cochrane methodological procedures. Our primary outcomes were: 1) incidence of symptomatic or test-positive COVID-19 infection in HCWs; 2) significant adverse event: anosmia (or disturbance in sense of smell). Our secondary outcomes were: 3) viral content of aerosol, when present (if intervention administered to patients); 4) other adverse events: changes in microbiome in oral cavity, nasal cavity, oro- or nasopharynx; 5) other adverse events: allergy, irritation/burning of nasal, oral or oropharyngeal mucosa (e.g. erosions, ulcers, bleeding), long-term staining of mucous membranes or teeth, accidental ingestion. We planned to use GRADE to assess the certainty of the evidence for each outcome.

Main Results: We found no completed studies to include in this review. We identified three ongoing studies (including two RCTs), which aim to enrol nearly 700 participants. The interventions included in these trials are povidone iodine, nitric oxide and GLS-1200 oral spray (the constituent of this spray is unclear and may not be antimicrobial in nature).   AUTHORS' CONCLUSIONS: We identified no studies for inclusion in this review. This is not surprising given the relatively recent emergence of COVID-19 infection. It is promising that the question posed in this review is being addressed by two RCTs and a non-randomised study. We are concerned that only one of the ongoing studies specifically states that it will evaluate adverse events and it is not clear if this will include changes in the sense of smell or to the oral and nasal microbiota, and any consequences thereof. Very few interventions have large and dramatic effect sizes. If a positive treatment effect is demonstrated when studies are available for inclusion in this review, it may not be large. In these circumstances in particular, where those receiving the intervention are otherwise fit and well, it may be a challenge to weigh up the benefits against the harms if the latter are of uncertain frequency and severity.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8202127PMC
September 2020

Antimicrobial mouthwashes (gargling) and nasal sprays administered to patients with suspected or confirmed COVID-19 infection to improve patient outcomes and to protect healthcare workers treating them.

Cochrane Database Syst Rev 2020 09 16;9:CD013627. Epub 2020 Sep 16.

Cochrane Oral Health, Division of Dentistry, School of Medical Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK.

Background: COVID-19 infection poses a serious risk to patients and - due to its contagious nature - to those healthcare workers (HCWs) treating them. If the mouth and nose of patients with infection are irrigated with antimicrobial solutions, this may help the patients by killing any coronavirus present at those sites. It may also reduce the risk of the active infection being passed to HCWs through droplet transmission or direct contact. However, the use of such antimicrobial solutions may be associated with harms related to the toxicity of the solutions themselves or alterations in the natural microbial flora of the mouth or nose.

Objectives: To assess the benefits and harms of antimicrobial mouthwashes and nasal sprays administered to patients with suspected or confirmed COVID-19 infection to both the patients and the HCWs caring for them.

Search Methods: Information Specialists from Cochrane ENT and Cochrane Oral Health searched the Central Register of Controlled Trials (CENTRAL 2020, Issue 6); Ovid MEDLINE; Ovid Embase and additional sources for published and unpublished trials. The date of the search was 1 June 2020.  SELECTION CRITERIA: This is a question that urgently requires evidence, however at the present time we did not anticipate finding many completed RCTs. We therefore planned to include the following types of studies: randomised controlled trials (RCTs); quasi-RCTs; non-randomised controlled trials; prospective cohort studies; retrospective cohort studies; cross-sectional studies; controlled before-and-after studies. We set no minimum duration for the studies.   We sought studies comparing antimicrobial mouthwash and/or nasal spray (alone or in combination) at any concentration, delivered with any frequency or dosage to suspected/confirmed COVID-19 patients.

Data Collection And Analysis: We used standard Cochrane methodological procedures. Our primary outcomes were: 1) RECOVERY* (www.recoverytrial.net) outcomes in patients (mortality; hospitalisation status; use of ventilation; use of renal dialysis or haemofiltration); 2) incidence of symptomatic or test-positive COVID-19 infection in HCWs; 3) significant adverse event: anosmia (or disturbance in sense of smell). Our secondary outcomes were: 4) change in COVID-19 viral load in patients; 5) COVID-19 viral content of aerosol (when present); 6) other adverse events: changes in microbiome in oral cavity, nasal cavity, oro- or nasopharynx; 7) other adverse events: allergy, irritation/burning of nasal, oral or oropharyngeal mucosa (e.g. erosions, ulcers, bleeding), long-term staining of mucous membranes or teeth, accidental ingestion. We planned to use GRADE to assess the certainty of the evidence for each outcome.

Main Results: We found no completed studies to include in this review. We identified 16 ongoing studies (including 14 RCTs), which aim to enrol nearly 1250 participants. The interventions included in these trials are ArtemiC (artemisinin, curcumin, frankincense and vitamin C), Citrox (a bioflavonoid), cetylpyridinium chloride, chlorhexidine, chlorine dioxide, essential oils, hydrogen peroxide, hypertonic saline, Kerecis spray (omega 3 viruxide - containing neem oil and St John's wort), neem extract, nitric oxide releasing solution, povidone iodine and saline with baby shampoo.  AUTHORS' CONCLUSIONS: We identified no studies for inclusion in this review. This is not surprising given the relatively recent emergence of COVID-19 infection. It is promising that the question posed in this review is being addressed by a number of RCTs and other studies. We are concerned that few of the ongoing studies specifically state that they will evaluate adverse events such as changes in the sense of smell or to the oral and nasal microbiota, and any consequences thereof. Very few interventions have large and dramatic effect sizes. If a positive treatment effect is demonstrated when studies are available for inclusion in this review, it may not be large. In these circumstances in particular it may be a challenge to weigh up the benefits against the harms if the latter are of uncertain frequency and severity.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8187985PMC
September 2020

Antimicrobial mouthwashes (gargling) and nasal sprays to protect healthcare workers when undertaking aerosol-generating procedures (AGPs) on patients without suspected or confirmed COVID-19 infection.

Cochrane Database Syst Rev 2020 09 16;9:CD013628. Epub 2020 Sep 16.

Cochrane Oral Health, Division of Dentistry, School of Medical Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK.

Background: COVID-19 infection poses a serious risk to patients and - due to its contagious nature - to those healthcare workers (HCWs) treating them. The risks of transmission of infection are greater when a patient is undergoing an aerosol-generating procedure (AGP). Not all those with COVID-19 infection are symptomatic, or suspected of harbouring the infection. If a patient who is not known to have or suspected of having COVID-19 infection is to undergo an AGP, it would nonetheless be sensible to minimise the risk to those HCWs treating them. If the mouth and nose of an individual undergoing an AGP are irrigated with antimicrobial solutions, this may be a simple and safe method of reducing the risk of any covert infection being passed to HCWs through droplet transmission or direct contact. Alternatively, the use of antimicrobial solutions by the HCW may decrease the chance of them acquiring COVID-19 infection. However, the use of such antimicrobial solutions may be associated with harms related to the toxicity of the solutions themselves or alterations in the natural microbial flora of the mouth or nose.

Objectives: To assess the benefits and harms of antimicrobial mouthwashes and nasal sprays administered to HCWs and/or patients when undertaking AGPs on patients without suspected or confirmed COVID-19 infection.

Search Methods: Information Specialists from Cochrane ENT and Cochrane Oral Health searched the Central Register of Controlled Trials (CENTRAL 2020, Issue 6); Ovid MEDLINE; Ovid Embase and additional sources for published and unpublished trials. The date of the search was 1 June 2020.  SELECTION CRITERIA: This is a question that urgently requires evidence, however at the present time we did not anticipate finding many completed RCTs. We therefore planned to include the following types of studies: randomised controlled trials (RCTs); quasi-RCTs; non-randomised controlled trials; prospective cohort studies; retrospective cohort studies; cross-sectional studies; controlled before-and-after studies. We set no minimum duration for the studies.   We sought studies comparing any antimicrobial mouthwash and/or nasal spray (alone or in combination) at any concentration, delivered to the patient or HCW before and/or after an AGP.

Data Collection And Analysis: We used standard Cochrane methodological procedures. Our primary outcomes were: 1) incidence of symptomatic or test-positive COVID-19 infection in HCWs or patients; 2) significant adverse event: anosmia (or disturbance in sense of smell). Our secondary outcomes were: 3) COVID-19 viral content of aerosol (when present); 4) change in COVID-19 viral load at site(s) of irrigation; 5) other adverse events: changes in microbiome in oral cavity, nasal cavity, oro- or nasopharynx; 6) other adverse events: allergy, irritation/burning of nasal, oral or oropharyngeal mucosa (e.g. erosions, ulcers, bleeding), long-term staining of mucous membranes or teeth, accidental ingestion. We planned to use GRADE to assess the certainty of the evidence for each outcome.

Main Results: We found no completed studies to include in this review.   AUTHORS' CONCLUSIONS: We identified no studies for inclusion in this review, nor any ongoing studies. The absence of completed studies is not surprising given the relatively recent emergence of COVID-19 infection. However, we are disappointed that this important clinical question is not being addressed by ongoing studies.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8188293PMC
September 2020

Surgical techniques for the removal of mandibular wisdom teeth.

Cochrane Database Syst Rev 2020 07 26;7:CD004345. Epub 2020 Jul 26.

Institute of Dentistry, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.

Background: Pathology relating to mandibular wisdom teeth is a frequent presentation to oral and maxillofacial surgeons, and surgical removal of mandibular wisdom teeth is a common operation. The indications for surgical removal of these teeth are alleviation of local pain, swelling and trismus, and also the prevention of spread of infection that may occasionally threaten life. Surgery is commonly associated with short-term postoperative pain, swelling and trismus. Less frequently, infection, dry socket (alveolar osteitis) and trigeminal nerve injuries may occur. This review focuses on the optimal methods in order to improve patient experience and minimise postoperative morbidity.

Objectives: To compare the relative benefits and risks of different techniques for surgical removal of mandibular wisdom teeth.

Search Methods: Cochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health Trials Register (to 8 July 2019), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library; 2019, Issue 6), MEDLINE Ovid (1946 to 8 July 2019), and Embase Ovid (1980 to 8 July 2019). We searched ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform for ongoing trials. We placed no restrictions on the language or date of publication.

Selection Criteria: Randomised controlled trials comparing different surgical techniques for the removal of mandibular wisdom teeth.

Data Collection And Analysis: Three review authors were involved in assessing the relevance of identified studies, evaluated the risk of bias in included studies and extracted data. We used risk ratios (RRs) for dichotomous data in parallel-group trials (or Peto odds ratios if the event rate was low), odds ratios (ORs) for dichotomous data in cross-over or split-mouth studies, and mean differences (MDs) for continuous data. We took into account the pairing of the split-mouth studies in our analyses, and combined parallel-group and split-mouth studies using the generic inverse-variance method. We used the fixed-effect model for three studies or fewer, and random-effects model for more than three studies.

Main Results: We included 62 trials with 4643 participants. Several of the trials excluded individuals who were not in excellent health. We assessed 33 of the studies (53%) as being at high risk of bias and 29 as unclear. We report results for our primary outcomes below. Comparisons of different suturing techniques and of drain versus no drain did not report any of our primary outcomes. No studies provided useable data for any of our primary outcomes in relation to coronectomy. There is insufficient evidence to determine whether envelope or triangular flap designs led to more alveolar osteitis (OR 0.33, 95% confidence interval (CI) 0.09 to 1.23; 5 studies; low-certainty evidence), wound infection (OR 0.29, 95% CI 0.04 to 2.06; 2 studies; low-certainty evidence), or permanent altered tongue sensation (Peto OR 4.48, 95% CI 0.07 to 286.49; 1 study; very low-certainty evidence). In terms of other adverse effects, two studies reported wound dehiscence at up to 30 days after surgery, but found no difference in risk between interventions. There is insufficient evidence to determine whether the use of a lingual retractor affected the risk of permanent altered sensation compared to not using one (Peto OR 0.14, 95% CI 0.00 to 6.82; 1 study; very low-certainty evidence). None of our other primary outcomes were reported by studies included in this comparison. There is insufficient evidence to determine whether lingual split with chisel is better than a surgical hand-piece for bone removal in terms of wound infection (OR 1.00, 95% CI 0.31 to 3.21; 1 study; very low-certainty evidence). Alveolar osteitis, permanent altered sensation, and other adverse effects were not reported. There is insufficient evidence to determine whether there is any difference in alveolar osteitis according to irrigation method (mechanical versus manual: RR 0.33, 95% CI 0.01 to 8.09; 1 study) or irrigation volume (high versus low; RR 0.52, 95% CI 0.27 to 1.02; 1 study), or whether there is any difference in postoperative infection according to irrigation method (mechanical versus manual: RR 0.50, 95% CI 0.05 to 5.43; 1 study) or irrigation volume (low versus high; RR 0.17, 95% CI 0.02 to 1.37; 1 study) (all very low-certainty evidence). These studies did not report permanent altered sensation and adverse effects. There is insufficient evidence to determine whether primary or secondary wound closure led to more alveolar osteitis (RR 0.99, 95% CI 0.41 to 2.40; 3 studies; low-certainty evidence), wound infection (RR 4.77, 95% CI 0.24 to 96.34; 1 study; very low-certainty evidence), or adverse effects (bleeding) (RR 0.41, 95% CI 0.11 to 1.47; 1 study; very low-certainty evidence). These studies did not report permanent sensation changes. Placing platelet rich plasma (PRP) or platelet rich fibrin (PRF) in sockets may reduce the incidence of alveolar osteitis (OR 0.39, 95% CI 0.22 to 0.67; 2 studies), but the evidence is of low certainty. Our other primary outcomes were not reported.

Authors' Conclusions: In this 2020 update, we added 27 new studies to the original 35 in the 2014 review. Unfortunately, even with the addition of these studies, we have been unable to draw many meaningful conclusions. The small number of trials evaluating each comparison and reporting our primary outcomes, along with methodological biases in the included trials, means that the body of evidence for each of the nine comparisons evaluated is of low or very low certainty. Participant populations in the trials may not be representative of the general population, or even the population undergoing third molar surgery. Many trials excluded individuals who were not in good health, and several excluded those with active infection or who had deep impactions of their third molars. Consequently, we are unable to make firm recommendations to surgeons to inform their techniques for removal of mandibular third molars. The evidence is uncertain, though we note that there is some limited evidence that placing PRP or PRF in sockets may reduce the incidence of dry socket. The evidence provided in this review may be used as a guide for surgeons when selecting and refining their surgical techniques. Ongoing studies may allow us to provide more definitive conclusions in the future.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7389870PMC
July 2020

Agreement was moderate between data-based and opinion-based assessments of biases affecting randomized trials within meta-analyses.

J Clin Epidemiol 2020 09 13;125:16-25. Epub 2020 May 13.

Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK; NIHR Applied Research Collaboration (ARC) West, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.

Background And Objective: Randomized trials included in meta-analyses are often affected by bias caused by methodological flaws or limitations, but the degree of bias is unknown. Two proposed methods adjust the trial results for bias using empirical evidence from published meta-epidemiological studies or expert opinion.

Methods: We investigated agreement between data-based and opinion-based approaches to assessing bias in each of four domains: sequence generation, allocation concealment, blinding, and incomplete outcome data. From each sampled meta-analysis, a pair of trials with the highest and lowest empirical model-based bias estimates was selected. Independent assessors were asked which trial within each pair was judged more biased on the basis of detailed trial design summaries.

Results: Assessors judged trials to be equally biased in 68% of pairs evaluated. When assessors judged one trial as more biased, the proportion of judgments agreeing with the model-based ranking was highest for allocation concealment (79%) and blinding (79%) and lower for sequence generation (59%) and incomplete outcome data (56%).

Conclusion: Most trial pairs found to be discrepant empirically were judged to be equally biased by assessors. We found moderate agreement between opinion and data-based evidence in pairs where assessors ranked one trial as more biased.
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http://dx.doi.org/10.1016/j.jclinepi.2020.05.009DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7482431PMC
September 2020

Omega-3 fatty acids for the primary and secondary prevention of cardiovascular disease.

Cochrane Database Syst Rev 2020 02 29;3:CD003177. Epub 2020 Feb 29.

University of East Anglia, Norwich Medical School, Norwich Research Park, Norwich, Norfolk, UK, NR4 7TJ.

Background: Omega-3 polyunsaturated fatty acids from oily fish (long-chain omega-3 (LCn3)), including eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)), as well as from plants (alpha-linolenic acid (ALA)) may benefit cardiovascular health. Guidelines recommend increasing omega-3-rich foods, and sometimes supplementation, but recent trials have not confirmed this.

Objectives: To assess the effects of increased intake of fish- and plant-based omega-3 fats for all-cause mortality, cardiovascular events, adiposity and lipids.

Search Methods: We searched CENTRAL, MEDLINE and Embase to February 2019, plus ClinicalTrials.gov and World Health Organization International Clinical Trials Registry to August 2019, with no language restrictions. We handsearched systematic review references and bibliographies and contacted trial authors.

Selection Criteria: We included randomised controlled trials (RCTs) that lasted at least 12 months and compared supplementation or advice to increase LCn3 or ALA intake, or both, versus usual or lower intake.

Data Collection And Analysis: Two review authors independently assessed trials for inclusion, extracted data and assessed validity. We performed separate random-effects meta-analysis for ALA and LCn3 interventions, and assessed dose-response relationships through meta-regression.

Main Results: We included 86 RCTs (162,796 participants) in this review update and found that 28 were at low summary risk of bias. Trials were of 12 to 88 months' duration and included adults at varying cardiovascular risk, mainly in high-income countries. Most trials assessed LCn3 supplementation with capsules, but some used LCn3- or ALA-rich or enriched foods or dietary advice compared to placebo or usual diet. LCn3 doses ranged from 0.5 g a day to more than 5 g a day (19 RCTs gave at least 3 g LCn3 daily). Meta-analysis and sensitivity analyses suggested little or no effect of increasing LCn3 on all-cause mortality (risk ratio (RR) 0.97, 95% confidence interval (CI) 0.93 to 1.01; 143,693 participants; 11,297 deaths in 45 RCTs; high-certainty evidence), cardiovascular mortality (RR 0.92, 95% CI 0.86 to 0.99; 117,837 participants; 5658 deaths in 29 RCTs; moderate-certainty evidence), cardiovascular events (RR 0.96, 95% CI 0.92 to 1.01; 140,482 participants; 17,619 people experienced events in 43 RCTs; high-certainty evidence), stroke (RR 1.02, 95% CI 0.94 to 1.12; 138,888 participants; 2850 strokes in 31 RCTs; moderate-certainty evidence) or arrhythmia (RR 0.99, 95% CI 0.92 to 1.06; 77,990 participants; 4586 people experienced arrhythmia in 30 RCTs; low-certainty evidence). Increasing LCn3 may slightly reduce coronary heart disease mortality (number needed to treat for an additional beneficial outcome (NNTB) 334, RR 0.90, 95% CI 0.81 to 1.00; 127,378 participants; 3598 coronary heart disease deaths in 24 RCTs, low-certainty evidence) and coronary heart disease events (NNTB 167, RR 0.91, 95% CI 0.85 to 0.97; 134,116 participants; 8791 people experienced coronary heart disease events in 32 RCTs, low-certainty evidence). Overall, effects did not differ by trial duration or LCn3 dose in pre-planned subgrouping or meta-regression. There is little evidence of effects of eating fish. Increasing ALA intake probably makes little or no difference to all-cause mortality (RR 1.01, 95% CI 0.84 to 1.20; 19,327 participants; 459 deaths in 5 RCTs, moderate-certainty evidence),cardiovascular mortality (RR 0.96, 95% CI 0.74 to 1.25; 18,619 participants; 219 cardiovascular deaths in 4 RCTs; moderate-certainty evidence), coronary heart disease mortality (RR 0.95, 95% CI 0.72 to 1.26; 18,353 participants; 193 coronary heart disease deaths in 3 RCTs; moderate-certainty evidence) and coronary heart disease events (RR 1.00, 95% CI 0.82 to 1.22; 19,061 participants; 397 coronary heart disease events in 4 RCTs; low-certainty evidence). However, increased ALA may slightly reduce risk of cardiovascular disease events (NNTB 500, RR 0.95, 95% CI 0.83 to 1.07; but RR 0.91, 95% CI 0.79 to 1.04 in RCTs at low summary risk of bias; 19,327 participants; 884 cardiovascular disease events in 5 RCTs; low-certainty evidence), and probably slightly reduces risk of arrhythmia (NNTB 91, RR 0.73, 95% CI 0.55 to 0.97; 4912 participants; 173 events in 2 RCTs; moderate-certainty evidence). Effects on stroke are unclear. Increasing LCn3 and ALA had little or no effect on serious adverse events, adiposity, lipids and blood pressure, except increasing LCn3 reduced triglycerides by ˜15% in a dose-dependent way (high-certainty evidence).

Authors' Conclusions: This is the most extensive systematic assessment of effects of omega-3 fats on cardiovascular health to date. Moderate- and low-certainty evidence suggests that increasing LCn3 slightly reduces risk of coronary heart disease mortality and events, and reduces serum triglycerides (evidence mainly from supplement trials). Increasing ALA slightly reduces risk of cardiovascular events and arrhythmia.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7049091PMC
February 2020

Oral splints for patients with temporomandibular disorders or bruxism: a systematic review and economic evaluation.

Health Technol Assess 2020 02;24(7):1-224

Health Economics Research Unit, University of Aberdeen, Aberdeen, UK.

Background: Splints are a non-invasive, reversible management option for temporomandibular disorders or bruxism. The clinical effectiveness and cost-effectiveness of splints remain uncertain.

Objectives: The objectives were to evaluate the clinical effectiveness and cost-effectiveness of splints for patients with temporomandibular disorders or bruxism. This evidence synthesis compared (1) all types of splint versus no/minimal treatment/control splints and (2) prefabricated versus custom-made splints, for the primary outcomes, which were pain (temporomandibular disorders) and tooth wear (bruxism).

Review Methods: Four databases, including MEDLINE and EMBASE, were searched from inception until 1 October 2018 for randomised clinical trials. The searches were conducted on 1 October 2018. Cochrane review methods (including risk of bias) were used for the systematic review. Standardised mean differences were pooled for the primary outcome of pain, using random-effects models in temporomandibular disorder patients. A Markov cohort, state-transition model, populated using current pain and Characteristic Pain Intensity data, was used to estimate the incremental cost-effectiveness ratio for splints compared with no splint, from an NHS perspective over a lifetime horizon. A value-of-information analysis identified future research priorities.

Results: Fifty-two trials were included in the systematic review. The evidence identified was of very low quality with unclear reporting by temporomandibular disorder subtype. When all subtypes were pooled into one global temporomandibular disorder group, there was no evidence that splints reduced pain [standardised mean difference (at up to 3 months) -0.18, 95% confidence interval -0.42 to 0.06; substantial heterogeneity] when compared with no splints or a minimal intervention. There was no evidence that other outcomes, including temporomandibular joint noises, decreased mouth-opening, and quality of life, improved when using splints. Adverse events were generally not reported, but seemed infrequent when reported. The most plausible base-case incremental cost-effectiveness ratio was uncertain and driven by the lack of clinical effectiveness evidence. The cost-effectiveness acceptability curve showed splints becoming more cost-effective at a willingness-to-pay threshold of ≈£6000, but the probability never exceeded 60% at higher levels of willingness to pay. Results were sensitive to longer-term extrapolation assumptions. A value-of-information analysis indicated that further research is required. There were no studies measuring tooth wear in patients with bruxism. One small study looked at pain and found a reduction in the splint group [mean difference (0-10 scale) -2.01, 95% CI -1.40 to -2.62; very low-quality evidence]. As there was no evidence of a difference between splints and no splints, the second objective became irrelevant.

Limitations: There was a large variation in the diagnostic criteria, splint types and outcome measures used and reported. Sensitivity analyses based on these limitations did not indicate a reduction in pain.

Conclusions: The very low-quality evidence identified did not demonstrate that splints reduced pain in temporomandibular disorders as a group of conditions. There is insufficient evidence to determine whether or not splints reduce tooth wear in patients with bruxism. There remains substantial uncertainty surrounding the most plausible incremental cost-effectiveness ratio.

Future Work: There is a need for well-conducted trials to determine the clinical effectiveness and cost-effectiveness of splints in patients with carefully diagnosed and subtyped temporomandibular disorders, and patients with bruxism, using agreed measures of pain and tooth wear.

Study Registration: This study is registered as PROSPERO CRD42017068512.

Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 24, No. 7. See the NIHR Journals Library website for further project information.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7049908PMC
February 2020

Oral splints for temporomandibular disorder or bruxism: a systematic review.

Br Dent J 2020 02;228(3):191-197

Health Economics Research Unit, University of Aberdeen, UK.

Objectives To evaluate the clinical-effectiveness of oral splints for patients with TMD or bruxism for the primary outcomes: pain (TMD) and tooth wear (bruxism).Data sources Four databases including MEDLINE and EMBASE were searched from inception until 1 October 2018.Data selection and extraction Randomised controlled trials comparing all types of splints versus no/minimal treatment for patients with TMD or bruxism were eligible. Standard Cochrane review methods were used. Standardised mean differences (SMD) were pooled for the primary outcome of pain, using random effects models in TMD patients.Data synthesis Thirty-seven trials were included and the evidence identified was of very low certainty using GRADE assessments. When all subtypes of TMD were pooled into one global TMD group, there was no evidence that splints reduced pain: SMD (up to 3 months) -0.18 (95% CI -0.42 to 0.06); 13 trials, 1,076 participants. There was no evidence that any other outcomes improved when using splints. There was no evidence of adverse events associated with splints, but reporting was poor regarding this outcome. No trials measured tooth wear in patients with bruxism. There was a large variation in diagnostic criteria, splint types and outcome measures used and reported. Sensitivity analyses based on these factors did not indicate a reduction in pain.Conclusions The very low-certainty evidence identified did not demonstrate that splints reduced pain in TMD as a group of conditions. There is insufficient evidence to determine whether splints reduce tooth wear in patients with bruxism.
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http://dx.doi.org/10.1038/s41415-020-1250-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7718146PMC
February 2020

WITHDRAWN: Interventions for replacing missing teeth: different types of dental implants.

Cochrane Database Syst Rev 2019 Oct 10;10:CD003815. Epub 2019 Oct 10.

Cochrane Oral Health, Division of Dentistry, School of Medical Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, JR Moore Building, Oxford Road, Manchester, UK, M13 9PL.

Background: Dental implants are available in different materials, shapes and with different surface characteristics. In particular, numerous implant designs and surface modifications have been developed for improving clinical outcome. This is an update of a Cochrane review first published in 2002, and previously updated in 2003, 2005 and 2007.

Objectives: Primary: to compare the clinical effects of different root-formed osseointegrated dental implant types for replacing missing teeth for the following specific comparisons: implants with different surface preparations, but having similar shape and material; implants with different shapes, but having similar surface preparation and material; implants made of different materials, but having similar surface preparation and shape; different implant types differing in surface preparation, shape, material or a combination of these.Secondary: to compare turned and roughened dental implants for occurrence of early implant failure (before prosthetic loading) and occurrence of peri-implantitis.

Search Methods: We searched the following electronic databases: the Cochrane Oral Health Group's Trials Register (to 17 January 2014), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 12), MEDLINE via OVID (1946 to 17 January 2014) and EMBASE via OVID (1980 to 17 January 2014). We placed no restrictions on the language or date of publication when searching the electronic databases.

Selection Criteria: We included any randomised controlled trial (RCT) comparing osseointegrated dental implants of different materials, shapes and surface properties having a follow-up in function of at least one year. Outcome measures were success of the implants, radiographic peri-implant marginal bone levels changes and incidence of peri-implantitis.

Data Collection And Analysis: At least two review authors independently conducted screening, risk of bias assessment and data extraction of eligible trials in duplicate. We expressed results using fixed-effect models (if up to three studies were present in a meta-analysis) or random-effects models (when there were more than three studies) using mean differences (MD) for continuous outcomes and risk ratios (RR) for dichotomous outcomes with 95% confidence intervals (CI). We reported the following endpoints: one, three, five and 10 years after functional loading.

Main Results: We identified 81 different RCTs. We included 27 of these RCTs, reporting results from 1512 participants and 3230 implants in the review. We compared 38 different implant types with a follow-up ranging from one to 10 years. All implants were made of commercially pure titanium or its alloys, and had different shapes and surface preparations. We judged two trials to be at low risk of bias, 10 to be at unclear risk of bias and 15 to be at high risk of bias. On a 'per participant' rather than 'per implant' basis, we found no significant differences between various implant types for implant failures. The only observed statistically significant difference for the primary objective regarded more peri-implant bone loss at Nobel Speedy Groovy implants when compared with NobelActive implants (MD -0.59 mm; 95% CI -0.74 to -0.44, different implant shapes). The only observed statistically significant difference for the secondary objective was that implants with turned (smoother) surfaces had a 20% reduction in risk to be affected by peri-implantitis than implants with rough surfaces three years after loading (RR 0.80; 95% CI 0.67 to 0.96). There was a tendency for implants with turned surfaces to fail early more often than implants with roughened surfaces.

Authors' Conclusions: Based on the results of the included RCTs, we found no evidence showing that any particular type of dental implant had superior long-term success. There was limited evidence showing that implants with relatively smooth (turned) surfaces were less prone to lose bone due to chronic infection (peri-implantitis) than implants with much rougher surfaces (titanium-plasma-sprayed). These findings were based on several RCTs, often at high risk of bias, with few participants and relatively short follow-up periods.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6786862PMC
October 2019

WITHDRAWN: Interventions for replacing missing teeth: partially absent dentition.

Cochrane Database Syst Rev 2019 Jul 17;7:CD003814. Epub 2019 Jul 17.

Department of Dentistry, Illinois Masonic Medical Center, 811 W Wellington, Chicago, IL, USA, 60657.

Background: Management of individuals presenting with partial loss of teeth is a common task for dentists. Outcomes important to the management of missing teeth in the partially absent dentition should be systematically summarized. This review recognizes both the challenges associated with such a summarization and the critical nature of the information for patients.

Objectives: To assess the effects of different prostheses for the treatment of partially absent dentition in terms of the following outcomes: long-term success, function, morbidity and patient satisfaction.

Search Methods: We searched the Cochrane Oral Health Group's Trials Register (to 21 March 2011), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 1), MEDLINE via OVID (1950 to March 2011) and EMBASE via OVID (1980 to March 2011). There were no restrictions regarding language or date of publication. We contacted several authors to identify non-published trials.

Selection Criteria: Randomized controlled trials (RCTs) comparing different methods (including the design and materials used) of treating partial edentulism, with clinically relevant outcomes, were included in this review. Trials reporting only surrogate outcomes, such as plaque accumulation or gingival volume, were excluded from this review.

Data Collection And Analysis: Two review authors independently carried out the screening of eligible studies, assessment of dimensions of quality of trials, and data extraction. Results were expressed as mean differences for continuous data, risk ratios for dichotomous outcomes, and hazard ratios with 95% confidence intervals for time-to-event data.

Main Results: Twenty-one trials met the inclusion criteria for this review. Twenty-four per cent of these were assessed as being at high risk of bias and the remainder were at unclear risk of bias. The clinical heterogeneity among the included studies precluded any attempt at meta-analysis. There was insufficient evidence to determine whether one type of removable dental prosthesis (RDP) was better or worse than another. With fixed dental prostheses (FDPs), there was no evidence that high gold alloys are better or worse than other alloys, nor that gold alloys or frameworks are better or worse than titanium. There is insufficient evidence to determine whether zirconia is better or worse that other FDP materials, that ceramic abutments are better or worse than titanium, or that one cement was better or worse than another in retaining FDPs. There is insufficient evidence to determine the relative effectiveness of FDPs and RDPs in patients with shortened dental arch or to determine the relative advantages of implant supported FDPs versus tooth/implant supported FDPs.

Authors' Conclusions: Based on trials meeting the inclusion criteria for this review, there is insufficient evidence to recommend a particular method of tooth replacement for partially edentulous patients.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6699666PMC
July 2019

WITHDRAWN: Guided tissue regeneration for periodontal infra-bony defects.

Cochrane Database Syst Rev 2019 05 29;5:CD001724. Epub 2019 May 29.

Unit of Periodontology and International Centre for Evidence-Based Oral Health, UCL Eastman Dental Institute, 256 Gray's Inn Road, London, UK, WC1X 8LD.

Background: Conventional treatment of destructive periodontal (gum) disease arrests the disease but does not usually regain the bone support or connective tissue lost in the disease process. Guided tissue regeneration (GTR) is a surgical procedure that specifically aims to regenerate the periodontal tissues when the disease is advanced and could overcome some of the limitations of conventional therapy.

Objectives: To assess the efficacy of GTR in the treatment of periodontal infra-bony defects measured against conventional surgery (open flap debridement (OFD)) and factors affecting outcomes.

Search Methods: We conducted an electronic search of the Cochrane Oral Health Group Trials Register, MEDLINE and EMBASE up to April 2004. Handsearching included Journal of Periodontology, Journal of Clinical Periodontology, Journal of Periodontal Research and bibliographies of all relevant papers and review articles up to April 2004. In addition, we contacted experts/groups/companies involved in surgical research to find other trials or unpublished material or to clarify ambiguous or missing data and posted requests for data on two periodontal electronic discussion groups.

Selection Criteria: Randomised, controlled trials (RCTs) of at least 12 months duration comparing guided tissue regeneration (with or without graft materials) with open flap debridement for the treatment of periodontal infra-bony defects. Furcation involvements and studies specifically treating aggressive periodontitis were excluded.

Data Collection And Analysis: Screening of possible studies and data extraction was conducted independently. The methodological quality of studies was assessed in duplicate using individual components and agreement determined by Kappa scores. Methodological quality was used in sensitivity analyses to test the robustness of the conclusions. The Cochrane Collaboration statistical guidelines were followed and the results expressed as mean differences (MD and 95% CI) for continuous outcomes and risk ratios (RR and 95% CI) for dichotomous outcomes calculated using random-effects models. Any heterogeneity was investigated. The primary outcome measure was change in clinical attachment.

Main Results: The search produced 626 titles, of these 596 were clearly not relevant to the review. The full text of 32 studies of possible relevance was obtained and 15 studies were excluded. Therefore 17 RCTs were included in this review, 16 studies testing GTR alone and two testing GTR + bone substitutes (one study had both test treatment arms).No tooth loss was reported in any study although these data are incomplete where patient follow up was not complete. For attachment level change, the mean difference between GTR and OFD was 1.22 mm (95% CI Random Effects: 0.80 to 1.64, Chi for heterogeneity 69.1 (df = 15), P < 0.001, I = 78%) and for GTR + bone substitutes was 1.25 mm (95% CI 0.89 to 1.61, Chi for heterogeneity 0.01 (df = 1), P = 0.91). GTR showed a significant benefit when comparing the numbers of sites failing to gain 2 mm attachment with risk ratio 0.54 (95% CI Random Effects: 0.31 to 0.96, Chi for heterogeneity 8.9 (df = 5), P = 0.11). The number needed to treat (NNT) for GTR to achieve one extra site gaining 2 mm or more attachment over open flap debridement was therefore 8 (95% CI 5 to 33), based on an incidence of 28% of sites in the control group failing to gain 2 mm or more of attachment. For baseline incidences in the range of the control groups of 3% and 55% the NNTs are 71 and 4.Probing depth reduction was greater for GTR than OFD: 1.21 mm (95% CI 0.53 to 1.88, Chi for heterogeneity 62.9 (df = 10), P < 0.001, I = 84%) or GTR + bone substitutes, weighted mean difference 1.24 mm (95% CI 0.89 to 1.59, Chi for heterogeneity 0.03 (df = 1), P = 0.85).For gingival recession, a statistically significant difference between GTR and open flap debridement controls was evident (mean difference 0.26 mm (95% CI Random Effects: 0.08, 0.43, Chi for heterogeneity 2.7 (df = 8), P = 0.95), with a greater change in recession from baseline for the control group.Regarding hard tissue probing at surgical re-entry, a statistically significant greater gain was found for GTR compared with open flap debridement. This amounted to a weighted mean difference of 1.39 mm (95% CI 1.08 to 1.71, Chi for heterogeneity 0.85 (df = 2), P = 0.65). For GTR + bone substitutes the difference was greater, with mean difference 3.37 mm (95% CI 3.14 to 3.61).Adverse effects were generally minor although with an increased treatment time for GTR. Exposure of the barrier membrane was frequently reported with a lack of evidence of an effect on healing.

Authors' Conclusions: GTR has a greater effect on probing measures of periodontal treatment than open flap debridement, including improved attachment gain, reduced pocket depth, less increase in gingival recession and more gain in hard tissue probing at re-entry surgery. However there is marked variability between studies and the clinical relevance of these changes is unknown. As a result, it is difficult to draw general conclusions about the clinical benefit of GTR. Whilst there is evidence that GTR can demonstrate a significant improvement over conventional open flap surgery, the factors affecting outcomes are unclear from the literature and these might include study conduct issues such as bias. Therefore, patients and health professionals need to consider the predictability of the technique compared with other methods of treatment before making final decisions on use. Since trial reports were often incomplete, we recommend that future trials should follow the CONSORT statement both in their conduct and reporting.There is therefore little value in future research repeating simple, small efficacy studies. The priority should be to identify factors associated with improved outcomes as well as investigating outcomes relevant to patients. Types of research might include large observational studies to generate hypotheses for testing in clinical trials, qualitative studies on patient-centred outcomes and trials exploring innovative analytic methods such as multilevel modelling. Open flap surgery should remain the control comparison in these studies.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6541039PMC
May 2019

WITHDRAWN: Interdental brushing for the prevention and control of periodontal diseases and dental caries in adults.

Cochrane Database Syst Rev 2019 04 24;4:CD009857. Epub 2019 Apr 24.

Cochrane Croatia, School of Medicine, University of Split, Soltanska 2, Split, Splitsko-dalmatinska County, Croatia, 21 000.

Background: Effective oral hygiene is a crucial factor in maintaining good oral health, which is associated with overall health and health-related quality of life. Dental floss has been used for many years in conjunction with toothbrushing for removing dental plaque in between teeth, however, interdental brushes have been developed which many people find easier to use than floss, providing there is sufficient space between the teeth.

Objectives: To evaluate the effects of interdental brushing in addition to toothbrushing, as compared with toothbrushing alone or toothbrushing and flossing for the prevention and control of periodontal diseases, dental plaque and dental caries.

Search Methods: We searched the following electronic databases: the Cochrane Oral Health Group's Trials Register (to 7 March 2013), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 2), MEDLINE via OVID (1946 to 7 March 2013), EMBASE via OVID (1980 to 7 March 2013), CINAHL via EBSCO (1980 to 7 March 2013), LILACS via BIREME (1982 to 7 March 2013), ZETOC Conference Proceedings (1980 to 7 March 2013) and Web of Science Conference Proceedings (1990 to 7 March 2013). We searched the US National Institutes of Health Trials Register (http://clinicaltrials.gov) and the metaRegister of Controlled Trials (http://www.controlled-trials.com/mrct/) for ongoing trials to 7 March 2013. No restrictions were placed on the language or date of publication when searching the electronic databases.

Selection Criteria: We included randomised controlled trials (including split-mouth design, cross-over and cluster-randomised trials) of dentate adult patients. The interventions were a combination of toothbrushing and any interdental brushing procedure compared with toothbrushing only or toothbrushing and flossing.

Data Collection And Analysis: At least two review authors assessed each of the included studies to confirm eligibility, assessed risk of bias and extracted data using a piloted data extraction form. We calculated standardised mean difference (SMD) and 95% confidence interval (CI) for continuous outcomes where different scales were used to assess an outcome. We attempted to extract data on adverse effects of interventions. Where data were missing or unclear we attempted to contact study authors to obtain further information.

Main Results: There were seven studies (total 354 participants analysed) included in this review. We assessed one study as being low, three studies as being high and three studies as being at unclear risk of bias. Studies only reported the clinical outcome gingivitis and plaque data, with no studies providing data on many of the outcomes: periodontitis, caries, halitosis and quality of life. Three studies reported that no adverse events were observed or reported during the study. Two other studies provided some data on adverse events but we were unable to pool the data due to lack of detail. Two studies did not report whether adverse events occurred.Interdental brushing in addition to toothbrushing, as compared with toothbrushing aloneOnly one high risk of bias study (62 participants in analysis) looked at this comparison and there was very low-quality evidence for a reduction in gingivitis (0 to 4 scale, mean in control): mean difference (MD) 0.53 (95% CI 0.23 to 0.83) and plaque (0 to 5 scale): MD 0.95 (95% CI 0.56 to 1.34) at one month, favouring of use of interdental brushes. This represents a 34% reduction in gingivitis and a 32% reduction in plaque.Interdental brushing in addition to toothbrushing, as compared with toothbrushing and flossingSeven studies provided data showing a reduction in gingivitis in favour of interdental brushing at one month: SMD -0.53 (95% CI -0.81 to -0.24, seven studies, 326 participants, low-quality evidence). This translates to a 52% reduction in gingivitis (Eastman Bleeding Index). Although a high effect size in the same direction was observed at three months (SMD -1.98, 95% CI -5.42 to 1.47, two studies, 107 participants, very low quality), the confidence interval was wide and did not exclude the possibility of no difference. There was insufficient evidence to claim a benefit for either interdental brushing or flossing for reducing plaque (SMD at one month 0.10, 95% CI -0.13 to 0.33, seven studies, 326 participants, low-quality evidence) and insufficient evidence at three months (SMD -2.14, 95% CI -5.25 to 0.97, two studies, 107 participants very low-quality evidence).

Authors' Conclusions: Only one study looked at whether toothbrushing with interdental brushing was better than toothbrushing alone, and there was very low-quality evidence for a reduction in gingivitis and plaque at one month. There is also low-quality evidence from seven studies that interdental brushing reduces gingivitis when compared with flossing, but these results were only found at one month. There was insufficient evidence to determine whether interdental brushing reduced or increased levels of plaque when compared to flossing.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6481275PMC
April 2019

WITHDRAWN: Flossing for the management of periodontal diseases and dental caries in adults.

Cochrane Database Syst Rev 2019 04 23;4:CD008829. Epub 2019 Apr 23.

Center for Evidence-Based Medicine and Health Care, Catholic University of Croatia, Ilica 242, Zagreb, Croatia, 10000.

Background: Good oral hygiene is thought to be important for oral health. This review is to determine the effectiveness of flossing in addition to toothbrushing for preventing gum disease and dental caries in adults.

Objectives: To assess the effects of flossing in addition to toothbrushing, as compared with toothbrushing alone, in the management of periodontal diseases and dental caries in adults.

Search Methods: We searched the following electronic databases: the Cochrane Oral Health Group Trials Register (to 17 October 2011), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 4), MEDLINE via OVID (1950 to 17 October 2011), EMBASE via OVID (1980 to 17 October 2011), CINAHL via EBSCO (1980 to 17 October 2011), LILACS via BIREME (1982 to 17 October 2011), ZETOC Conference Proceedings (1980 to 17 October 2011), Web of Science Conference Proceedings (1990 to 17 October 2011), Clinicaltrials.gov (to 17 October 2011) and the metaRegister of Controlled Clinical Trials (to 17 October 2011). We imposed no restrictions regarding language or date of publication. We contacted manufacturers of dental floss to identify trials.

Selection Criteria: We included randomised controlled trials conducted comparing toothbrushing and flossing with only toothbrushing, in adults.

Data Collection And Analysis: Two review authors independently assessed risk of bias for the included studies and extracted data. We contacted trial authors for further details where these were unclear. The effect measure for each meta-analysis was the standardised mean difference (SMD) with 95% confidence intervals (CI) using random-effects models. We examined potential sources of heterogeneity, along with sensitivity analyses omitting trials at high risk of bias.

Main Results: Twelve trials were included in this review, with a total of 582 participants in flossing plus toothbrushing (intervention) groups and 501 participants in toothbrushing (control) groups. All included trials reported the outcomes of plaque and gingivitis. Seven of the included trials were assessed as at unclear risk of bias and five were at high risk of bias.Flossing plus toothbrushing showed a statistically significant benefit compared to toothbrushing in reducing gingivitis at the three time points studied, the SMD being -0.36 (95% CI -0.66 to -0.05) at 1 month, SMD -0.41 (95% CI -0.68 to -0.14) at 3 months and SMD -0.72 (95% CI -1.09 to -0.35) at 6 months. The 1-month estimate translates to a 0.13 point reduction on a 0 to 3 point scale for Loe-Silness gingivitis index, and the 3 and 6 month results translate to 0.20 and 0.09 reductions on the same scale.Overall there is weak, very unreliable evidence which suggests that flossing plus toothbrushing may be associated with a small reduction in plaque at 1 or 3 months.None of the included trials reported data for the outcomes of caries, calculus, clinical attachment loss, or quality of life. There was some inconsistent reporting of adverse effects.

Authors' Conclusions: There is some evidence from twelve studies that flossing in addition to toothbrushing reduces gingivitis compared to toothbrushing alone. There is weak, very unreliable evidence from 10 studies that flossing plus toothbrushing may be associated with a small reduction in plaque at 1 and 3 months. No studies reported the effectiveness of flossing plus toothbrushing for preventing dental caries.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6478368PMC
April 2019

Home use of interdental cleaning devices, in addition to toothbrushing, for preventing and controlling periodontal diseases and dental caries.

Cochrane Database Syst Rev 2019 04 10;4:CD012018. Epub 2019 Apr 10.

Cochrane Oral Health, Division of Dentistry, School of Medical Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Coupland Building 3, Oxford Road, Manchester, UK, M13 9PL.

Background: Dental caries (tooth decay) and periodontal diseases (gingivitis and periodontitis) affect the majority of people worldwide, and treatment costs place a significant burden on health services. Decay and gum disease can cause pain, eating and speaking difficulties, low self-esteem, and even tooth loss and the need for surgery. As dental plaque is the primary cause, self-administered daily mechanical disruption and removal of plaque is important for oral health. Toothbrushing can remove supragingival plaque on the facial and lingual/palatal surfaces, but special devices (such as floss, brushes, sticks, and irrigators) are often recommended to reach into the interdental area.

Objectives: To evaluate the effectiveness of interdental cleaning devices used at home, in addition to toothbrushing, compared with toothbrushing alone, for preventing and controlling periodontal diseases, caries, and plaque. A secondary objective was to compare different interdental cleaning devices with each other.

Search Methods: Cochrane Oral Health's Information Specialist searched: Cochrane Oral Health's Trials Register (to 16 January 2019), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2018, Issue 12), MEDLINE Ovid (1946 to 16 January 2019), Embase Ovid (1980 to 16 January 2019) and CINAHL EBSCO (1937 to 16 January 2019). The US National Institutes of Health Trials Registry (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials. No restrictions were placed on the language or date of publication.

Selection Criteria: Randomised controlled trials (RCTs) that compared toothbrushing and a home-use interdental cleaning device versus toothbrushing alone or with another device (minimum duration four weeks).

Data Collection And Analysis: At least two review authors independently screened searches, selected studies, extracted data, assessed studies' risk of bias, and assessed evidence certainty as high, moderate, low or very low, according to GRADE. We extracted indices measured on interproximal surfaces, where possible. We conducted random-effects meta-analyses, using mean differences (MDs) or standardised mean differences (SMDs).

Main Results: We included 35 RCTs (3929 randomised adult participants). Studies were at high risk of performance bias as blinding of participants was not possible. Only two studies were otherwise at low risk of bias. Many participants had a low level of baseline gingival inflammation.Studies evaluated the following devices plus toothbrushing versus toothbrushing: floss (15 trials), interdental brushes (2 trials), wooden cleaning sticks (2 trials), rubber/elastomeric cleaning sticks (2 trials), oral irrigators (5 trials). Four devices were compared with floss: interdental brushes (9 trials), wooden cleaning sticks (3 trials), rubber/elastomeric cleaning sticks (9 trials) and oral irrigators (2 trials). Another comparison was rubber/elastomeric cleaning sticks versus interdental brushes (3 trials).No trials assessed interproximal caries, and most did not assess periodontitis. Gingivitis was measured by indices (most commonly, Löe-Silness, 0 to 3 scale) and by proportion of bleeding sites. Plaque was measured by indices, most often Quigley-Hein (0 to 5).

Primary Objective: comparisons against toothbrushing aloneLow-certainty evidence suggested that flossing, in addition to toothbrushing, may reduce gingivitis (measured by gingival index (GI)) at one month (SMD -0.58, 95% confidence interval (CI) -1.12 to -0.04; 8 trials, 585 participants), three months or six months. The results for proportion of bleeding sites and plaque were inconsistent (very low-certainty evidence).Very low-certainty evidence suggested that using an interdental brush, plus toothbrushing, may reduce gingivitis (measured by GI) at one month (MD -0.53, 95% CI -0.83 to -0.23; 1 trial, 62 participants), though there was no clear difference in bleeding sites (MD -0.05, 95% CI -0.13 to 0.03; 1 trial, 31 participants). Low-certainty evidence suggested interdental brushes may reduce plaque more than toothbrushing alone (SMD -1.07, 95% CI -1.51 to -0.63; 2 trials, 93 participants).Very low-certainty evidence suggested that using wooden cleaning sticks, plus toothbrushing, may reduce bleeding sites at three months (MD -0.25, 95% CI -0.37 to -0.13; 1 trial, 24 participants), but not plaque (MD -0.03, 95% CI -0.13 to 0.07).Very low-certainty evidence suggested that using rubber/elastomeric interdental cleaning sticks, plus toothbrushing, may reduce plaque at one month (MD -0.22, 95% CI -0.41 to -0.03), but this was not found for gingivitis (GI MD -0.01, 95% CI -0.19 to 0.21; 1 trial, 12 participants; bleeding MD 0.07, 95% CI -0.15 to 0.01; 1 trial, 30 participants).Very-low certainty evidence suggested oral irrigators may reduce gingivitis measured by GI at one month (SMD -0.48, 95% CI -0.89 to -0.06; 4 trials, 380 participants), but not at three or six months. Low-certainty evidence suggested that oral irrigators did not reduce bleeding sites at one month (MD -0.00, 95% CI -0.07 to 0.06; 2 trials, 126 participants) or three months, or plaque at one month (SMD -0.16, 95% CI -0.41 to 0.10; 3 trials, 235 participants), three months or six months, more than toothbrushing alone.

Secondary Objective: comparisons between devicesLow-certainty evidence suggested interdental brushes may reduce gingivitis more than floss at one and three months, but did not show a difference for periodontitis measured by probing pocket depth. Evidence for plaque was inconsistent.Low- to very low-certainty evidence suggested oral irrigation may reduce gingivitis at one month compared to flossing, but very low-certainty evidence did not suggest a difference between devices for plaque.Very low-certainty evidence for interdental brushes or flossing versus interdental cleaning sticks did not demonstrate superiority of either intervention.Adverse eventsStudies that measured adverse events found no severe events caused by devices, and no evidence of differences between study groups in minor effects such as gingival irritation.

Authors' Conclusions: Using floss or interdental brushes in addition to toothbrushing may reduce gingivitis or plaque, or both, more than toothbrushing alone. Interdental brushes may be more effective than floss. Available evidence for tooth cleaning sticks and oral irrigators is limited and inconsistent. Outcomes were mostly measured in the short term and participants in most studies had a low level of baseline gingival inflammation. Overall, the evidence was low to very low-certainty, and the effect sizes observed may not be clinically important. Future trials should report participant periodontal status according to the new periodontal diseases classification, and last long enough to measure interproximal caries and periodontitis.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6953268PMC
April 2019

Fluoride toothpastes of different concentrations for preventing dental caries.

Cochrane Database Syst Rev 2019 03 4;3:CD007868. Epub 2019 Mar 4.

Division of Dentistry, School of Medical Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Coupland Building 3, Oxford Road, Manchester, UK, M13 9PL.

Background: Caries (dental decay) is a disease of the hard tissues of the teeth caused by an imbalance, over time, in the interactions between cariogenic bacteria in dental plaque and fermentable carbohydrates (mainly sugars). Regular toothbrushing with fluoride toothpaste is the principal non-professional intervention to prevent caries, but the caries-preventive effect varies according to different concentrations of fluoride in toothpaste, with higher concentrations associated with increased caries control. Toothpastes with higher fluoride concentration increases the risk of fluorosis (enamel defects) in developing teeth. This is an update of the Cochrane Review first published in 2010.

Objectives: To determine and compare the effects of toothpastes of different fluoride concentrations (parts per million (ppm)) in preventing dental caries in children, adolescents, and adults.

Search Methods: Cochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 15 August 2018); the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 7) in the Cochrane Library (searched 15 August 2018); MEDLINE Ovid (1946 to 15 August 2018); and Embase Ovid (1980 to 15 August 2018). The US National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials (15 August 2018). No restrictions were placed on the language or date of publication when searching the electronic databases.

Selection Criteria: Randomised controlled trials that compared toothbrushing with fluoride toothpaste with toothbrushing with a non-fluoride toothpaste or toothpaste of a different fluoride concentration, with a follow-up period of at least 1 year. The primary outcome was caries increment measured by the change from baseline in the decayed, (missing), and filled surfaces or teeth index in all permanent or primary teeth (D(M)FS/T or d(m)fs/t).

Data Collection And Analysis: Two members of the review team, independently and in duplicate, undertook the selection of studies, data extraction, and risk of bias assessment. We graded the certainty of the evidence through discussion and consensus. The primary effect measure was the mean difference (MD) or standardised mean difference (SMD) caries increment. Where it was appropriate to pool data, we used random-effects pairwise or network meta-analysis.

Main Results: We included 96 studies published between 1955 and 2014 in this updated review. Seven studies with 11,356 randomised participants (7047 evaluated) reported the effects of fluoride toothpaste up to 1500 ppm on the primary dentition; one study with 2500 randomised participants (2008 evaluated) reported the effects of 1450 ppm fluoride toothpaste on the primary and permanent dentition; 85 studies with 48,804 randomised participants (40,066 evaluated) reported the effects of toothpaste up to 2400 ppm on the immature permanent dentition; and three studies with 2675 randomised participants (2162 evaluated) reported the effects of up to 1100 ppm fluoride toothpaste on the mature permanent dentition. Follow-up in most studies was 36 months.In the primary dentition of young children, 1500 ppm fluoride toothpaste reduces caries increment when compared with non-fluoride toothpaste (MD -1.86 dfs, 95% confidence interval (CI) -2.51 to -1.21; 998 participants, one study, moderate-certainty evidence); the caries-preventive effects for the head-to-head comparison of 1055 ppm versus 550 ppm fluoride toothpaste are similar (MD -0.05, dmfs, 95% CI -0.38 to 0.28; 1958 participants, two studies, moderate-certainty evidence), but toothbrushing with 1450 ppm fluoride toothpaste slightly reduces decayed, missing, filled teeth (dmft) increment when compared with 440 ppm fluoride toothpaste (MD -0.34, dmft, 95%CI -0.59 to -0.09; 2362 participants, one study, moderate-certainty evidence). The certainty of the remaining evidence for this comparison was judged to be low.We included 81 studies in the network meta-analysis of D(M)FS increment in the permanent dentition of children and adolescents. The network included 21 different comparisons of seven fluoride concentrations. The certainty of the evidence was judged to be low with the following exceptions: there was high- and moderate-certainty evidence that 1000 to 1250 ppm or 1450 to 1500 ppm fluoride toothpaste reduces caries increments when compared with non-fluoride toothpaste (SMD -0.28, 95% CI -0.32 to -0.25, 55 studies; and SMD -0.36, 95% CI -0.43 to -0.29, four studies); there was moderate-certainty evidence that 1450 to 1500 ppm fluoride toothpaste slightly reduces caries increments when compared to 1000 to 1250 ppm (SMD -0.08, 95% CI -0.14 to -0.01, 10 studies); and moderate-certainty evidence that the caries increments are similar for 1700 to 2200 ppm and 2400 to 2800 ppm fluoride toothpaste when compared to 1450 to 1500 ppm (SMD 0.04, 95% CI -0.07 to 0.15, indirect evidence only; SMD -0.05, 95% CI -0.14 to 0.05, two studies).In the adult permanent dentition, 1000 or 1100 ppm fluoride toothpaste reduces DMFS increment when compared with non-fluoride toothpaste in adults of all ages (MD -0.53, 95% CI -1.02 to -0.04; 2162 participants, three studies, moderate-certainty evidence). The evidence for DMFT was low certainty.Only a minority of studies assessed adverse effects of toothpaste. When reported, effects such as soft tissue damage and tooth staining were minimal.

Authors' Conclusions: This Cochrane Review supports the benefits of using fluoride toothpaste in preventing caries when compared to non-fluoride toothpaste. Evidence for the effects of different fluoride concentrations is more limited, but a dose-response effect was observed for D(M)FS in children and adolescents. For many comparisons of different concentrations the caries-preventive effects and our confidence in these effect estimates are uncertain and could be challenged by further research. The choice of fluoride toothpaste concentration for young children should be balanced against the risk of fluorosis.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6398117PMC
March 2019

Routine scale and polish for periodontal health in adults.

Cochrane Database Syst Rev 2018 12 27;12:CD004625. Epub 2018 Dec 27.

University of Dundee, Dental School & Hospital, Park Place, Dundee, Tayside, UK, DD1 4HN.

Background: Many dentists or hygienists provide scaling and polishing for patients at regular intervals, even for those at low risk of developing periodontal disease. There is debate over the clinical and cost effectiveness of 'routine scaling and polishing' and the optimal frequency at which it should be provided for healthy adults.A 'routine scale and polish' treatment is defined as scaling or polishing, or both, of the crown and root surfaces of teeth to remove local irritational factors (plaque, calculus, debris and staining), which does not involve periodontal surgery or any form of adjunctive periodontal therapy such as the use of chemotherapeutic agents or root planing. Routine scale and polish treatments are typically provided in general dental practice settings. The technique may also be referred to as prophylaxis, professional mechanical plaque removal or periodontal instrumentation.This review updates a version published in 2013.

Objectives: 1. To determine the beneficial and harmful effects of routine scaling and polishing for periodontal health.2. To determine the beneficial and harmful effects of routine scaling and polishing at different recall intervals for periodontal health.3. To determine the beneficial and harmful effects of routine scaling and polishing for periodontal health when the treatment is provided by dentists compared with dental care professionals (dental therapists or dental hygienists).

Search Methods: Cochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 10 January 2018), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2017, Issue 12), MEDLINE Ovid (1946 to 10 January 2018), and Embase Ovid (1980 to 10 January 2018). The US National Institutes of Health Trials Registry (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials. No restrictions were placed on the language or date of publication when searching the electronic databases.

Selection Criteria: Randomised controlled trials of routine scale and polish treatments, with or without oral hygiene instruction, in healthy dentate adults without severe periodontitis. We excluded split-mouth trials.

Data Collection And Analysis: Two review authors screened the results of the searches against inclusion criteria, extracted data and assessed risk of bias independently and in duplicate. We calculated mean differences (MDs) (or standardised mean differences (SMDs) when different scales were reported) and 95% confidence intervals (CIs) for continuous data. We calculated risk ratios (RR) and 95% CIs for dichotomous data. We used a fixed-effect model for meta-analyses. We contacted study authors when necessary to obtain missing information. We rated the certainty of the evidence using the GRADE approach.

Main Results: We included two studies with 1711 participants in the analyses. Both studies were conducted in UK general dental practices and involved adults without severe periodontitis who were regular attenders at dental appointments. One study measured outcomes at 24 months and the other at 36 months. Neither study measured adverse effects, changes in attachment level, tooth loss or halitosis.Comparison 1: routine scaling and polishing versus no scheduled scaling and polishingTwo studies compared planned, regular interval (six- and 12-monthly) scale and polish treatments versus no scheduled treatment. We found little or no difference between groups over a two- to three-year period for gingivitis, probing depths, oral health-related quality of life (all high-certainty evidence) and plaque (low-certainty evidence). The SMD for gingivitis when comparing six-monthly scale and polish treatment versus no scheduled treatment was -0.01 (95% CI -0.13 to 0.11; two trials, 1087 participants), and for 12-monthly scale and polish versus no scheduled treatment was -0.04 (95% CI -0.16 to 0.08; two trials, 1091 participants).Regular planned scale and polish treatments produced a small reduction in calculus levels over two to three years when compared with no scheduled scale and polish treatments (high-certainty evidence). The SMD for six-monthly scale and polish versus no scheduled treatment was -0.32 (95% CI -0.44 to -0.20; two trials, 1088 participants) and for 12-monthly scale and polish versus no scheduled treatment was -0.19 (95% CI -0.31 to -0.07; two trials, 1088 participants). The clinical importance of these small reductions is unclear.Participants' self-reported levels of oral cleanliness were higher when receiving six- and 12-monthly scale and polish treatments compared to no scheduled treatment, but the certainty of the evidence is low.Comparison 2: routine scaling and polishing at different recall intervalsTwo studies compared routine six-monthly scale and polish treatments versus 12-monthly treatments. We found little or no difference between groups over two to three years for the outcomes of gingivitis, probing depths, oral health-related quality of life (all high-certainty evidence) and plaque (low-certainty evidence). The SMD for gingivitis was 0.03 (95% CI -0.09 to 0.15; two trials, 1090 participants; I = 0%). Six- monthly scale and polish treatments produced a small reduction in calculus levels over a two- to three-year period when compared with 12-monthly treatments (SMD -0.13 (95% CI -0.25 to -0.01; 2 trials, 1086 participants; high-certainty evidence). The clinical importance of this small reduction is unclear.The comparative effects of six- and 12-monthly scale and polish treatments on patients' self-reported levels of oral cleanliness were uncertain (very low-certainty evidence).Comparison 3: routine scaling and polishing provided by dentists compared with dental care professionals (dental therapists or hygienists)No studies evaluated this comparison.The review findings in relation to costs were uncertain (very low-certainty evidence).

Authors' Conclusions: For adults without severe periodontitis who regularly access routine dental care, routine scale and polish treatment makes little or no difference to gingivitis, probing depths and oral health-related quality of life over two to three years follow-up when compared with no scheduled scale and polish treatments (high-certainty evidence). There may also be little or no difference in plaque levels over two years (low-certainty evidence). Routine scaling and polishing reduces calculus levels compared with no routine scaling and polishing, with six-monthly treatments reducing calculus more than 12-monthly treatments over two to three years follow-up (high-certainty evidence), although the clinical importance of these small reductions is uncertain. Available evidence on the costs of the treatments is uncertain. The studies did not assess adverse effects.
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http://dx.doi.org/10.1002/14651858.CD004625.pub5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6516960PMC
December 2018

Interventions for the treatment of oral and oropharyngeal cancers: surgical treatment.

Cochrane Database Syst Rev 2018 12 24;12:CD006205. Epub 2018 Dec 24.

School of Dentistry, The University of Western Australia, 17 Monash Avenue, Nedlands, Western Australia, Australia, 6009.

Background: Surgery is an important part of the management of oral cavity cancer with regard to both the removal of the primary tumour and removal of lymph nodes in the neck. Surgery is less frequently used in oropharyngeal cancer. Surgery alone may be treatment for early-stage disease or surgery may be used in combination with radiotherapy, chemotherapy and immunotherapy/biotherapy. There is variation in the recommended timing and extent of surgery in the overall treatment regimens of people with these cancers. This is an update of a review originally published in 2007 and first updated in 2011.

Objectives: To determine which surgical treatment modalities for oral and oropharyngeal cancers result in increased overall survival, disease-free survival and locoregional control and reduced recurrence. To determine the implication of treatment modalities in terms of morbidity, quality of life, costs, hospital days of treatment, complications and harms.

Search Methods: Cochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 20 December 2017), the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 11), MEDLINE Ovid (1946 to 20 December 2017) and Embase Ovid (1980 to 20 December 2017). We searched the US National Institutes of Health Trials Registry (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform for ongoing trials. There were no restrictions on the language or date of publication.

Selection Criteria: Randomised controlled trials where more than 50% of participants had primary tumours of the oral cavity or oropharynx, or where separate data could be extracted for these participants, and that compared two or more surgical treatment modalities, or surgery versus other treatment modalities.

Data Collection And Analysis: Two or more review authors independently extracted data and assessed risk of bias. We contacted study authors for additional information as required. We collected adverse events data from included studies.

Main Results: We identified five new trials in this update, bringing the total number of included trials to 12 (2300 participants; 2148 with cancers of the oral cavity). We assessed four trials at high risk of bias, and eight at unclear. None of the included trials compared different surgical approaches for the excision of the primary tumour. We grouped the trials into seven main comparisons.Future research may change the findings as there is only very low-certainty evidence available for all results.Five trials compared elective neck dissection (ND) with therapeutic (delayed) ND in participants with oral cavity cancer and clinically negative neck nodes, but differences in type of surgery and duration of follow-up made meta-analysis inappropriate in most cases. Four of these trials reported overall and disease-free survival. The meta-analyses of two trials found no evidence of either intervention leading to greater overall survival (hazard ratio (HR) 0.84, 95% confidence interval (CI) 0.41 to 1.72; 571 participants), or disease-free survival (HR 0.73, 95% CI 0.25 to 2.11; 571 participants), but one trial found a benefit for elective supraomohyoid ND compared to therapeutic ND in overall survival (RR 0.40, 95% CI 0.19 to 0.84; 67 participants) and disease-free survival (HR 0.32, 95% CI 0.12 to 0.84; 67 participants). Four individual trials assessed locoregional recurrence, but could not be meta-analysed; one trial favoured elective ND over therapeutic delayed ND, while the others were inconclusive.Two trials compared elective radical ND with elective selective ND, but we were unable to pool the data for two outcomes. Neither study found evidence of a difference in overall survival or disease-free survival. A single trial found no evidence of a difference in recurrence.One trial compared surgery plus radiotherapy with radiotherapy alone, but data were unreliable because the trial stopped early and there were multiple protocol violations.One trial comparing positron-emission tomography-computed tomography (PET-CT) following chemoradiotherapy (with ND only if no or incomplete response) versus planned ND (either before or after chemoradiotherapy), showed no evidence of a difference in mortality (HR 0.92, 95% CI 0.65 to 1.31; 564 participants). The trial did not provide usable data for the other outcomes.Three single trials compared: surgery plus adjunctive radiotherapy versus chemoradiotherapy; supraomohyoid ND versus modified radical ND; and super selective ND versus selective ND. There were no useable data from these trials.The reporting of adverse events was poor. Four trials measured adverse events. Only one of the trials reported quality of life as an outcome.

Authors' Conclusions: Twelve randomised controlled trials evaluated ND surgery in people with oral cavity cancers; however, the evidence available for all comparisons and outcomes is very low certainty, therefore we cannot rely on the findings. The evidence is insufficient to draw conclusions about elective ND of clinically negative neck nodes at the time of removal of the primary tumour compared to therapeutic (delayed) ND. Two trials combined in meta-analysis suggested there is no difference between these interventions, while one trial (which evaluated elective supraomohyoid ND) found that it may be associated with increased overall and disease-free survival. One trial found elective ND reduced locoregional recurrence, while three were inconclusive. There is no evidence that radical ND increases overall or disease-free survival compared to more conservative ND surgery, or that there is a difference in mortality between PET-CT surveillance following chemoradiotherapy versus planned ND (before or after chemoradiotherapy). Reporting of adverse events in all trials was poor and it was not possible to compare the quality of life of people undergoing different surgical treatments.
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http://dx.doi.org/10.1002/14651858.CD006205.pub4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6517307PMC
December 2018

Omega-3 fatty acids for the primary and secondary prevention of cardiovascular disease.

Cochrane Database Syst Rev 2018 11 30;11:CD003177. Epub 2018 Nov 30.

Norwich Medical School, University of East Anglia, Norwich Research Park, Norwich, Norfolk, UK, NR4 7TJ.

Background: Researchers have suggested that omega-3 polyunsaturated fatty acids from oily fish (long-chain omega-3 (LCn3), including eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)), as well as from plants (alpha-linolenic acid (ALA)) benefit cardiovascular health. Guidelines recommend increasing omega-3-rich foods, and sometimes supplementation, but recent trials have not confirmed this.

Objectives: To assess effects of increased intake of fish- and plant-based omega-3 for all-cause mortality, cardiovascular (CVD) events, adiposity and lipids.

Search Methods: We searched CENTRAL, MEDLINE and Embase to April 2017, plus ClinicalTrials.gov and World Health Organization International Clinical Trials Registry to September 2016, with no language restrictions. We handsearched systematic review references and bibliographies and contacted authors.

Selection Criteria: We included randomised controlled trials (RCTs) that lasted at least 12 months and compared supplementation and/or advice to increase LCn3 or ALA intake versus usual or lower intake.

Data Collection And Analysis: Two review authors independently assessed studies for inclusion, extracted data and assessed validity. We performed separate random-effects meta-analysis for ALA and LCn3 interventions, and assessed dose-response relationships through meta-regression.

Main Results: We included 79 RCTs (112,059 participants) in this review update and found that 25 were at low summary risk of bias. Trials were of 12 to 72 months' duration and included adults at varying cardiovascular risk, mainly in high-income countries. Most studies assessed LCn3 supplementation with capsules, but some used LCn3- or ALA-rich or enriched foods or dietary advice compared to placebo or usual diet. LCn3 doses ranged from 0.5g/d LCn3 to > 5 g/d (16 RCTs gave at least 3g/d LCn3).Meta-analysis and sensitivity analyses suggested little or no effect of increasing LCn3 on all-cause mortality (RR 0.98, 95% CI 0.90 to 1.03, 92,653 participants; 8189 deaths in 39 trials, high-quality evidence), cardiovascular mortality (RR 0.95, 95% CI 0.87 to 1.03, 67,772 participants; 4544 CVD deaths in 25 RCTs), cardiovascular events (RR 0.99, 95% CI 0.94 to 1.04, 90,378 participants; 14,737 people experienced events in 38 trials, high-quality evidence), coronary heart disease (CHD) mortality (RR 0.93, 95% CI 0.79 to 1.09, 73,491 participants; 1596 CHD deaths in 21 RCTs), stroke (RR 1.06, 95% CI 0.96 to 1.16, 89,358 participants; 1822 strokes in 28 trials) or arrhythmia (RR 0.97, 95% CI 0.90 to 1.05, 53,796 participants; 3788 people experienced arrhythmia in 28 RCTs). There was a suggestion that LCn3 reduced CHD events (RR 0.93, 95% CI 0.88 to 0.97, 84,301 participants; 5469 people experienced CHD events in 28 RCTs); however, this was not maintained in sensitivity analyses - LCn3 probably makes little or no difference to CHD event risk. All evidence was of moderate GRADE quality, except as noted.Increasing ALA intake probably makes little or no difference to all-cause mortality (RR 1.01, 95% CI 0.84 to 1.20, 19,327 participants; 459 deaths, 5 RCTs),cardiovascular mortality (RR 0.96, 95% CI 0.74 to 1.25, 18,619 participants; 219 cardiovascular deaths, 4 RCTs), and CHD mortality (1.1% to 1.0%, RR 0.95, 95% CI 0.72 to 1.26, 18,353 participants; 193 CHD deaths, 3 RCTs) and ALA may make little or no difference to CHD events (RR 1.00, 95% CI 0.80 to 1.22, 19,061 participants, 397 CHD events, 4 RCTs, low-quality evidence). However, increased ALA may slightly reduce risk of cardiovascular events (from 4.8% to 4.7%, RR 0.95, 95% CI 0.83 to 1.07, 19,327 participants; 884 CVD events, 5 RCTs, low-quality evidence with greater effects in trials at low summary risk of bias), and probably reduces risk of arrhythmia (3.3% to 2.6%, RR 0.79, 95% CI 0.57 to 1.10, 4,837 participants; 141 events, 1 RCT). Effects on stroke are unclear.Sensitivity analysis retaining only trials at low summary risk of bias moved effect sizes towards the null (RR 1.0) for all LCn3 primary outcomes except arrhythmias, but for most ALA outcomes, effect sizes moved to suggest protection. LCn3 funnel plots suggested that adding in missing studies/results would move effect sizes towards null for most primary outcomes. There were no dose or duration effects in subgrouping or meta-regression.There was no evidence that increasing LCn3 or ALA altered serious adverse events, adiposity or lipids, except LCn3 reduced triglycerides by ˜15% in a dose-dependant way (high-quality evidence).

Authors' Conclusions: This is the most extensive systematic assessment of effects of omega-3 fats on cardiovascular health to date. Moderate- and high-quality evidence suggests that increasing EPA and DHA has little or no effect on mortality or cardiovascular health (evidence mainly from supplement trials). Previous suggestions of benefits from EPA and DHA supplements appear to spring from trials with higher risk of bias. Low-quality evidence suggests ALA may slightly reduce CVD event and arrhythmia risk.
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http://dx.doi.org/10.1002/14651858.CD003177.pub4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6517311PMC
November 2018

INTERVAL (investigation of NICE technologies for enabling risk-variable-adjusted-length) dental recalls trial: a multicentre randomised controlled trial investigating the best dental recall interval for optimum, cost-effective maintenance of oral health in dentate adults attending dental primary care.

BMC Oral Health 2018 08 7;18(1):135. Epub 2018 Aug 7.

University of Dundee School of Dentistry, Dundee, UK.

Background: Traditionally, patients at low risk and high risk of developing dental disease have been encouraged to attend dental recall appointments at regular intervals of six months between appointments. The lack of evidence for the effect that different recall intervals between dental check-ups have on patient outcomes, provider workload and healthcare costs is causing considerable uncertainty for the profession and patients, despite the publication of the NICE Guideline on dental recall. The need for primary research has been highlighted in the Health Technology Assessment Group's systematic review of routine dental check-ups, which found little evidence to support or refute the practice of encouraging 6-monthly dental check-ups in adults. The more recent Cochrane review on recall interval concluded there was insufficient evidence to draw any conclusions regarding the potential beneficial or harmful effects of altering the recall interval between dental check-ups. There is therefore an urgent need to assess the relative effectiveness and cost-benefit of different dental recall intervals in a robust, sufficiently powered randomised control trial (RCT) in primary dental care.

Methods: This is a four year multi-centre, parallel-group, randomised controlled trial with blinded outcome assessment based in dental primary care in the UK. Practitioners will recruit 2372 dentate adult patients. Patient participants will be randomised to one of three groups: fixed-period six month recall, risk-based recall, or fixed-period twenty-four month recall. Outcome data will be assessed through clinical examination, patient questionnaires and NHS databases. The primary outcomes measure gingival inflammation/bleeding on probing and oral health-related quality of life.

Discussion: INTERVAL will provide evidence for the most clinically-effective and cost-beneficial recall interval for maintaining optimum oral health in dentate adults attending general dental practice.

Trial Registration: ISRCTN95933794 (Date assigned 20/08/2008).
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http://dx.doi.org/10.1186/s12903-018-0587-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6081817PMC
August 2018
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