Publications by authors named "Gail Douglas"

32 Publications

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

The Dental Team: An Additional Resource for Delivering Vaccinations.

Front Med (Lausanne) 2020 6;7:606242. Epub 2020 Nov 6.

School of Dentistry, University of Leeds, Leeds, United Kingdom.

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http://dx.doi.org/10.3389/fmed.2020.606242DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7677565PMC
November 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://dx.doi.org/10.3310/hta24600DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7701991PMC
November 2020

Clinician and Patient Factors Influencing Treatment Decisions: Ethnographic Study of Antibiotic Prescribing and Operative Procedures in Out-of-Hours and General Dental Practices.

Antibiotics (Basel) 2020 Sep 4;9(9). Epub 2020 Sep 4.

Faculty of Medicine and Health, University of Leeds, Leeds LS2 9LU, UK.

Operative treatment is indicated for most toothache/dental abscesses, yet antibiotics instead of procedures are often prescribed. This ethnographic study aimed to identify clinician and patient factors influencing urgent dental care for adults during actual appointments; and to identify elements sensitive to context. Appointments were observed in out-of-hours and general dental practices. Follow-up interviews took place with dentists, dental nurses, and patients. Dentist and patient factors were identified through thematic analysis of observation records and appointment/interview transcripts. Dentist factors were based on a published list of factors influencing antibiotic prescribing for adults with acute conditions across primary health care and presented within the Capability-Opportunity-Motivation-Behaviour model. Contextually sensitive elements were revealed by comparing the factors between settings. In total, thirty-one dentist factors and nineteen patient factors were identified. Beliefs about antibiotics, goals for the appointment and access to dental services were important for both dentists and patients. Dentist factors included beliefs about the lifetime impact of urgent dental procedures on patients. Patient factors included their communication and negotiation skills. Contextual elements included dentists' concerns about inflicting pain on regular patients in general dental practice; and patients' difficulties accessing care to complete temporary treatment provided out of hours. This improved understanding of factors influencing shared decisions about treatments presents significant opportunity for new, evidence-based, contextually sensitive antibiotic stewardship interventions.
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http://dx.doi.org/10.3390/antibiotics9090575DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7558392PMC
September 2020

Study Protocol for an Online Questionnaire Survey on Symptoms/Signs, Protective Measures, Level of Awareness and Perception Regarding COVID-19 Outbreak among Dentists. A Global Survey.

Int J Environ Res Public Health 2020 Aug 3;17(15). Epub 2020 Aug 3.

Department of Restorative, Preventive and Paediatric Dentistry, University of Bern, Freiburgstrasse 7, 3012 Bern, Switzerland.

The Centres for Disease Control and Prevention and the World Health Organization have developed preparedness and prevention checklists for healthcare professionals regarding the containment of COVID-19. The aim of the present protocol is to evaluate the impact of the COVID-19 outbreak among dentists in different countries where various prevalence of the epidemic has been reported. Several research groups around the world were contacted by the central management team. The online anonymous survey will be conducted on a convenience sample of dentists working both in national health systems and in private or public clinics. In each country/area, a high (~5-20%) proportion of dentists working there will be invited to participate. The questionnaire, developed and standardized previously in Italy, has four domains: (1) personal data; (2) symptoms/signs relative to COVID-19; (3) working conditions and PPE (personal protective equipment) adopted after the infection's outbreak; (4) knowledge and self-perceived risk of infection. The methodology of this international survey will include translation, pilot testing, and semantic adjustment of the questionnaire. The data will be entered on an Excel spreadsheet and quality checked. Completely anonymous data analyses will be performed by the central management team. This survey will give an insight into the dental profession during COVID-19 pandemic globally.
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http://dx.doi.org/10.3390/ijerph17155598DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7432089PMC
August 2020

The FiCTION trial: Child oral health-related quality of life and dental anxiety across three treatment strategies for managing caries in young children.

Community Dent Oral Epidemiol 2020 08 27;48(4):328-337. Epub 2020 Apr 27.

School of Dentistry, University of Leeds, Leeds, UK.

Objectives: The FiCTION trial compared co-primary outcomes (dental pain and/or infection) and secondary outcomes (child oral health-related quality of life [COHRQOL], child dental anxiety, cost-effectiveness, caries development/progression and acceptability) across three treatment strategies (Conventional with Prevention [C + P]; Biological with Prevention [B + P]; Prevention Alone [PA]) for managing caries in children in primary care. COHRQOL and child dental anxiety experiences are reported upon here.

Methods: A multi-centre, 3-arm, parallel-group, unblinded patient-randomized controlled trial of 3- to 7-year-olds treated under NHS contracts was conducted in 72 general dental practices in England, Wales and Scotland. Child participants (with at least one primary molar with dentinal caries) were randomized (1:1:1) to one of three treatment arms with the intention of being managed according to allocated arm for 3 years (minimum 23 months). Randomization was via a centrally administered system using random permuted blocks of variable length. At baseline and final visit, accompanying parents/caregivers completed a parental questionnaire including COHRQOL (16 item P-CPQ-16), and at every visit, child- and parental-questionnaire-based data were collected for child-based dental trait and state anxiety. Statistical analyses were conducted on complete cases from the modified intention-to-treat (mITT) analysis set.

Results: A total of 1144 children were randomized (C + P: 386; B + P: 381; PA: 377). The mITT analysis set included the 1058 children who attended at least one study visit (C + P: 352; B + P: 352; PA: 354). Median follow-up was 33.8 months (IQR: 23.8, 36.7). The P-CPQ-16 overall score could be calculated after simple imputation at both baseline and final visit for 560 children (C + P: 189; B + P: 189; PA: 182). There was no evidence of a difference in the estimated adjusted mean P-CPQ-16 at the final visit which was, on average, 0.3 points higher (97.5% CI: -1.1 to 1.6) in B + P than C + P and 0.2 points higher, on average, (97.5% CI: -1.2 to 1.5) in PA than for C + P. Child dental trait anxiety and child dental state anxiety, measured at every treatment visit, showed no evidence of any statistically or clinically significant difference between arms in adjusted mean scores averaged over all follow-up visits.

Conclusions: The differences noted in COHRQOL and child-based dental trait and dental state anxiety measures across three treatment strategies for managing dental caries in primary teeth were small, and not considered to be clinically meaningful. The findings highlight the importance of including all three strategies in a clinician's armamentarium, to manage childhood caries throughout the young child's life and achieve positive experiences of dental care.
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http://dx.doi.org/10.1111/cdoe.12537DOI Listing
August 2020

Children and parents' perspectives on the acceptability of three management strategies for dental caries in primary teeth within the 'Filling Children's Teeth: Indicated or Not' (FiCTION) randomised controlled trial - a qualitative study.

BMC Oral Health 2020 03 12;20(1):69. Epub 2020 Mar 12.

School of Clinical Dentistry, Claremont Crescent, Sheffield, S10 2TA, UK.

Background: The Filling Children's Teeth: Indicated Or Not? (FiCTION) randomised controlled trial (RCT) aimed to explore the clinical- and cost-effectiveness of managing dental caries in children's primary teeth. The trial compared three management strategies: conventional caries management with best practice prevention (C + P), biological management with best practice prevention (B + P) and best practice prevention alone (PA)-based approaches. Recently, the concept of treatment acceptability has gained attention and attempts have been made to provide a conceptual definition, however this has mainly focused on adults. Recognising the importance of evaluating the acceptability of interventions in addition to their effectiveness, particularly for multi-component complex interventions, the trial design included a qualitative component. The aim of this component was to explore the acceptability of the three strategies from the perspectives of the child participants and their parents.

Methods: Qualitative exploration, based on the concept of acceptability. Participants were children already taking part in the FiCTION trial and their parents. Children were identified through purposive maximum variation sampling. The sample included children from the three management strategy arms who had been treated and followed up; median (IQR) follow-up was at 33.8 (23.8, 36.7) months. Semi-structured interviews with thirteen child-parent dyads. Interviews were transcribed verbatim and analysed using a framework approach.

Results: Data saturation was reached after thirteen interviews. Each child-parent dyad took part in one interview together. The participants were eight girls and five boys aged 5-11 years and their parents. The children's distribution across the trial arms was: C + P n = 4; B + P n = 5; PA n = 4. Three key factors influenced the acceptability of caries management in primary teeth to children and parents: i) experiences of specific procedures within management strategies; ii) experiences of anticipatory dental anxiety and; iii) perceptions of effectiveness (particularly whether pain was reduced). These factors were underpinned by a fourth key factor: the notion of trust in the dental professionals - this was pervasive across all arms.

Conclusions: Overall children and parents found each of the three strategies for the management of dental caries in primary teeth acceptable, with trust in the dental professional playing an important role.
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http://dx.doi.org/10.1186/s12903-020-1060-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7069198PMC
March 2020

Dental professionals' experiences of managing children with carious lesions in their primary teeth - a qualitative study within the FiCTION randomised controlled trial.

BMC Oral Health 2020 03 4;20(1):64. Epub 2020 Mar 4.

School of Dentistry, University of Dundee, Park Place, Dundee, DD1 4HN, UK.

Background: The lack of evidence for the effective management of carious lesions in children's primary teeth has caused uncertainty for the dental profession and patients. Possible approaches include conventional and biological management alongside best practice prevention, and best practice prevention alone. The FiCTION trial assessed the effectiveness of these options, and included a qualitative study exploring dental professionals' (DPs) experiences of delivering the different treatment arms. This paper reports on how DPs managed children with carious lesions within FiCTION and how this related to their everyday experiences of doing dentistry.

Methods: Overall, 31 DPs from FiCTION-trained dental surgeries in four regions of the UK participated in semi-structured interviews about their experiences of the three treatment arms (conventional management of carious lesions and prevention (C + P), biological management of carious lesions and prevention (B + P) or prevention alone (PA)). A theoretical framework, drawing on social practice theory (SPT), was developed for analysis.

Results: Participants discussed perceived effectiveness of, and familiarity with, the three techniques. The C + P arm was familiar, but some participants questioned the effectiveness of conventional restorations. Attitudes towards the B + P arm varied in terms of familiarity, but once DPs were introduced to the techniques, this was seen as effective. While prevention was familiar, PA was described as ineffective. DPs manage children with carious lesions day-to-day, drawing on previous experience and knowledge of the child to provide what they view as the most appropriate treatment in the best interests of each child. Randomisation undermined these normal choices. Several DPs reported deviating from the trial arms in order to treat a patient in a particular way. Participants valued evidence-based dentistry, and expect to use the results of FiCTION to inform future practice. They anticipate continuing to use the full range of treatment options, and to personally select appropriate strategies for individual children.

Conclusions: RCTs take place in the context of day-to-day practices of doing dentistry. DPs employ experiential and interpersonal knowledge to act in the best interests of their patients. Randomisation within a clinical trial can present a source of tension for DPs, which has implications for assuring individual equipoise in future trials.
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http://dx.doi.org/10.1186/s12903-020-1051-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7057668PMC
March 2020

Non-traumatic dental presentations at accident and emergency departments in the UK: a systematic review.

Br Dent J 2020 02;228(3):171-176

Dental Public Health, University of Leeds, Leeds, UK.

Objective Attendance at accident and emergency departments (A&E) for non-traumatic dental conditions (NTDC) is increasing in high-income countries. Not all NTDC visits to A&E are inappropriate; however, those that are take up capacity with conditions which are adding to the pressure regarding cost and healthcare utilisation for A&E departments. The scale of this problem is yet to be understood in the United Kingdom (UK). The aim of this study was to systematically review the literature to identify peer-reviewed research publications reporting non-traumatic dental presentations at A&E departments in the UK.Data sources A structured search of Cochrane Library, EMBASE, MEDLINE, CINAHL, PsycINFO, Scopus and Web of Science databases from their earliest date to May 2018. Hand-searching of identified articles that met the inclusion criteria was also reviewed.Data selection Publications were included if they were primary research on A&E users in the UK with NTDC as the primary reason for the A&E visit.Data extraction Data were extracted on the study, patient and visit characteristics.Data synthesis Studies were assessed for methodological quality and the analysis took the form of a narrative review.Conclusion There is limited evidence, of variable quality, to inform on the extent of inappropriate presentations of patients with non-urgent NTDC to A&E departments in the UK. The evidence supports the hypothesis that dental patients are inappropriately seeking care for NTDC at A&E departments and this may be a driver of unnecessary antibiotic prescriptions. Further research should focus on the reasons for this occurrence.
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http://dx.doi.org/10.1038/s41415-020-1247-xDOI Listing
February 2020

Cost-effectiveness of child caries management: a randomised controlled trial (FiCTION trial).

BMC Oral Health 2020 02 10;20(1):45. Epub 2020 Feb 10.

Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, NE2 4AX, UK.

Background: A three-arm parallel group, randomised controlled trial set in general dental practices in England, Scotland, and Wales was undertaken to evaluate three strategies to manage dental caries in primary teeth. Children, with at least one primary molar with caries into dentine, were randomised to receive Conventional with best practice prevention (C + P), Biological with best practice prevention (B + P), or best practice Prevention Alone (PA).

Methods: Data on costs were collected via case report forms completed by clinical staff at every visit. The co-primary outcomes were incidence of, and number of episodes of, dental pain and/or infection avoided. The three strategies were ranked in order of mean cost and a more costly strategy was compared with a less costly strategy in terms of incremental cost-effectiveness. Costs and outcomes were discounted at 3.5%.

Results: A total of 1144 children were randomised with data on 1058 children (C + P n = 352, B + P n = 352, PA n = 354) used in the analysis. On average, it costs £230 to manage dental caries in primary teeth over a period of up to 36 months. Managing children in PA was, on average, £19 (97.5% CI: -£18 to £55) less costly than managing those in B + P. In terms of effectiveness, on average, there were fewer incidences of, (- 0.06; 97.5% CI: - 0.14 to 0.02) and fewer episodes of dental pain and/or infection (- 0.14; 97.5% CI: - 0.29 to 0.71) in B + P compared to PA. C + P was unlikely to be considered cost-effective, as it was more costly and less effective than B + P.

Conclusions: The mean cost of a child avoiding any dental pain and/or infection (incidence) was £330 and the mean cost per episode of dental pain and/or infection avoided was £130. At these thresholds B + P has the highest probability of being considered cost-effective. Over the willingness to pay thresholds considered, the probability of B + P being considered cost-effective never exceeded 75%.

Trial Registration: The trial was prospectively registered with the ISRCTN (reference number ISRCTN77044005) on the 26th January 2009 and East of Scotland Research Ethics Committee provided ethical approved (REC reference: 12/ES/0047).
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http://dx.doi.org/10.1186/s12903-020-1020-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7011536PMC
February 2020

Best-practice prevention alone or with conventional or biological caries management for 3- to 7-year-olds: the FiCTION three-arm RCT.

Health Technol Assess 2020 01;24(1):1-174

School of Dentistry, University of Dundee, Dundee, UK.

Background: Historically, lack of evidence for effective management of decay in primary teeth has caused uncertainty, but there is emerging evidence to support alternative strategies to conventional fillings, which are minimally invasive and prevention orientated.

Objectives: The objectives were (1) to assess the clinical effectiveness and cost-effectiveness of three strategies for managing caries in primary teeth and (2) to assess quality of life, dental anxiety, the acceptability and experiences of children, parents and dental professionals, and caries development and/or progression.

Design: This was a multicentre, three-arm parallel-group, participant-randomised controlled trial. Allocation concealment was achieved by use of a centralised web-based randomisation facility hosted by Newcastle Clinical Trials Unit.

Setting: This trial was set in primary dental care in Scotland, England and Wales.

Participants: Participants were NHS patients aged 3-7 years who were at a high risk of tooth decay and had at least one primary molar tooth with decay into dentine, but no pain/sepsis.

Interventions: Three interventions were employed: (1) conventional with best-practice prevention (local anaesthetic, carious tissue removal, filling placement), (2) biological with best-practice prevention (sealing-in decay, selective carious tissue removal and fissure sealants) and (3) best-practice prevention alone (dietary and toothbrushing advice, topical fluoride and fissure sealing of permanent teeth).

Main Outcome Measures: The clinical effectiveness outcomes were the proportion of children with at least one episode (incidence) and the number of episodes, for each child, of dental pain or dental sepsis or both over the follow-up period. The cost-effectiveness outcomes were the cost per incidence of, and cost per episode of, dental pain and/or dental sepsis avoided over the follow-up period.

Results: A total of 72 dental practices were recruited and 1144 participants were randomised (conventional arm,  = 386; biological arm,  = 381; prevention alone arm,  = 377). Of these, 1058 were included in an intention-to-treat analysis (conventional arm,  = 352; biological arm,  = 352; prevention alone arm,  = 354). The median follow-up time was 33.8 months (interquartile range 23.8-36.7 months). The proportion of children with at least one episode of pain or sepsis or both was 42% (conventional arm), 40% (biological arm) and 45% (prevention alone arm). There was no evidence of a difference in incidence or episodes of pain/sepsis between arms. When comparing the biological arm with the conventional arm, the risk difference was -0.02 (97.5% confidence interval -0.10 to 0.06), which indicates, on average, a 2% reduced risk of dental pain and/or dental sepsis in the biological arm compared with the conventional arm. Comparing the prevention alone arm with the conventional arm, the risk difference was 0.04 (97.5% confidence interval -0.04 to 0.12), which indicates, on average, a 4% increased risk of dental pain and/or dental sepsis in the prevention alone arm compared with the conventional arm. Compared with the conventional arm, there was no evidence of a difference in episodes of pain/sepsis among children in the biological arm (incident rate ratio 0.95, 97.5% confidence interval 0.75 to 1.21, which indicates that there were slightly fewer episodes, on average, in the biological arm than the conventional arm) or in the prevention alone arm (incident rate ratio 1.18, 97.5% confidence interval 0.94 to 1.48, which indicates that there were slightly more episodes in the prevention alone arm than the conventional arm). Over the willingness-to-pay values considered, the probability of the biological treatment approach being considered cost-effective was approximately no higher than 60% to avoid an incidence of dental pain and/or dental sepsis and no higher than 70% to avoid an episode of pain/sepsis.

Conclusions: There was no evidence of an overall difference between the three treatment approaches for experience of, or number of episodes of, dental pain or dental sepsis or both over the follow-up period.

Future Work: Recommendations for future work include exploring barriers to the use of conventional techniques for carious lesion detection and diagnosis (e.g. radiographs) and developing and evaluating suitable techniques and strategies for use in young children in primary care.

Trial Registration: Current Controlled Trials ISRCTN77044005.

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. 1. See the NIHR Journals Library website for further project information.
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http://dx.doi.org/10.3310/hta24010DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6983909PMC
January 2020

'He was distraught, I was distraught.' Parents' experiences of accessing emergency care following an avulsion injury to their child.

Br Dent J 2019 Oct;227(8):705-710

Department of Paediatric Dentistry, School of Dentistry, University of Leeds, United Kingdom; Community Dental Service, Bradford District Care NHS Trust, Bradford, UK.

Objective To explore how parents access emergency care for their children following avulsion of a permanent tooth.Method Semi-structured qualitative interviews were undertaken with parents of children who had suffered a tooth avulsion injury in the previous two years. The interviews were recorded and transcribed verbatim. Framework analysis was used to analyse the data and interpret the core concepts from the interviews. Results Nine parents participated in the study. None of the children received the appropriate emergency dental care within the timeframe identified by national and international guidelines. The core themes that emerged following the analysis were knowledge, access and emotion.Discussion & Conclusions The parents who were interviewed for this study had poor knowledge of what to do in the event of a tooth avulsion injury. This lack of knowledge directly impaired their ability to navigate emergency dental care for their child. They described their upset and distress following their child's injury, but also feelings of frustration and disappointment in relation to the emergency care their child received. There is a need to develop appropriate support and clinical pathways to enable parents to rapidly access appropriate and timely care for their child following a complex dental trauma.
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http://dx.doi.org/10.1038/s41415-019-0738-0DOI Listing
October 2019

Remuneration of primary dental care in England: a qualitative framework analysis of perspectives of a new service delivery model incorporating incentives for improved access, quality and health outcomes.

BMJ Open 2019 10 3;9(10):e031886. Epub 2019 Oct 3.

Health Economics Group, University of Exeter, Exeter, UK

Objective: This study aimed to describe stakeholder perspectives of a new service delivery model in primary care dentistry incorporating incentives for access, quality and health outcomes.

Design: Data were collected through observations, interviews and focus groups.

Setting: This was conducted under six UK primary dental care practices, three working under the incentive-driven contract and three working under the traditional activity-based contract.

Participants: Observations were made of 30 dental appointments. Eighteen lay people, 15 dental team staff and a member of a commissioning team took part in the interviews and focus groups.

Results: Using a qualitative framework analysis informed by Andersen's model of access, we found oral health assessments influenced patients' perceptions of need, which led to changes in preventive behaviour. Dentists responded to the contract, with greater emphasis on prevention, use of the disease risk ratings in treatment planning, adherence to the pathways and the utilisation of skill-mix. Participants identified increases in the capacity of practices to deliver more care as a result. These changes were seen to improve evaluated and perceived health and patient satisfaction. These outcomes fed back to shape people's predispositions to visit the dentist.

Conclusion: The incentive-driven contract was perceived to increase access to dental care, determine dentists' and patients' perceptions of need, their behaviours, health outcomes and patient satisfaction. Dentists face challenges in refocusing care, perceptions of preventive dentistry, deployment of skill mix and use of the risk assessments and care pathways. Dentists may need support in these areas and to recognise the differences between caring for individual patients and the patient-base of a practice.
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http://dx.doi.org/10.1136/bmjopen-2019-031886DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6797242PMC
October 2019

The views and experiences of general dental practitioners (GDP's) in West Yorkshire who used the International Caries Detection and Assessment System (ICDAS) in research.

PLoS One 2019 4;14(10):e0223376. Epub 2019 Oct 4.

School of Dentistry, University of Leeds, Leeds, United Kingdom.

Objective: To explore, through face to face interviews with a selection of General Dental Practitioners (GDPs), their views and experiences of having used the International Caries Detection and Assessment System (ICDAS) within primary care research studies for recording caries.

Methods: This qualitative study involved one on one interviews with eight GDP's who had previously used ICDAS on patients in their dental practices as part of a research study. The participants were selected from among those who had taken part in two clinical studies in the UK using convenient, but purposive sampling. The interviews were tape-recorded and transcribed; the data analysis was conducted by thematic analysis.

Results: GDP's indicated their beliefs that ICDAS had an important role in caries prevention but reported four main barriers while using the full (6 caries stages) ICDAS coding system in their practices: lack of simplicity of coding, financial implications and time consumption (in both training and use of ICDAS) and inadequate undergraduate training. An overarching theme identified from the GDPS was the willingness to offer potential solutions to their barriers which might improve the utilisation of the system in primary care.

Conclusion: The GDPs experienced common obstacles in using ICDAS in the primary care setting, many of which have relatively straight-forward solutions which they put forward themselves such as: incentivisation, undergraduate-level training in ICDAS for both dentists and nurses and computerized data entry. Further qualitative and quantitative research is needed on how to facilitate the utilisation of the system in dental practice. It is also recommended to explore the influences of wider agencies on influencing primary dental care professionals' caries management, including appropriate recording of diagnosis and risk assessment.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0223376PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6777823PMC
March 2020

CariesCare practice guide: consensus on evidence into practice.

Br Dent J 2019 Sep;227(5):353-362

Greifswald University, Greifswald, Germany.

This CariesCare practice guide is derived from the International Caries Classification and Management System (ICCMS) and provides a structured update for dentists to help them deliver optimal caries care and outcomes for their patients. This '4D cycle' is a practice-building format, which both prevents and controls caries and can engage patients as long-term health partners with their practice. CariesCare International (CCI™) promotes a patient-centred, risk-based approach to caries management designed for dental practice. This comprises a health outcomes-focused system that aims to maintain oral health and preserve tooth structure in the long-term. It guides the dental team through a four-step process (4D system), leading to personalised interventions: 1st D: Determine Caries Risk; 2nd D: Detect lesions, stage their severity and assess their activity status; 3rd D: Decide on the most appropriate care plan for the specific patient at that time; and then, finally, 4th D: Do the preventive and tooth-preserving care which is needed (including risk-appropriate preventive care; control of initial non-cavitated lesions; and conservative restorative treatment of deep dentinal and cavitated caries lesions). CariesCare International has designed this practice-friendly consensus guide to summarise best practice as informed by the best available evidence. Following the guide should also increase patient satisfaction, involvement, wellbeing and value, by being less invasive and more health-focused. For the dentist it should also provide benefits at the professional and practice levels including improved medico-legal protection.
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http://dx.doi.org/10.1038/s41415-019-0678-8DOI Listing
September 2019

I've got Toothache, I need Antibiotics: a UK Perspective on Rational Antibiotic Prescribing by Dentists.

Braz Dent J 2018 Jul-Aug;29(4):395-399

School of Dentistry, University of Leeds, Leeds, UK.

Antibiotics do not cure toothache. This headline message of the United Kingdom's (UK) Dental Antimicrobial Stewardship (AMS) toolkit's posters and leaflets is aimed at patients; clinicians are expected to know this already. Evidence based clinical guidelines exist to set clear standards for good clinical practice yet there are barriers to compliance. The national AMS audit tool is designed for clinicians to review their management of acute dental conditions, including but not limited to the prescription of antibiotics. In this article we aim to help dental teams protect their patients and themselves from adverse events related to antibiotic prescription. It explores the emergent problem of Clostridium difficile, antibiotic resistance and severe sepsis, and considers some of the barriers, which clinicians have suggested, contribute to the unjustified prescription of antibiotics. Dentists must weigh the risks against the benefits before prescribing any antibiotic.
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http://dx.doi.org/10.1590/0103-6440201802200DOI Listing
March 2019

Variations in the provision and cost of oral healthcare in 11 European countries: a case study.

Int Dent J 2019 Apr 19;69(2):130-140. Epub 2018 Sep 19.

School of Dentistry, University of Leeds, Leeds, UK.

Aim: To compare the provision and costs at the point of delivery of dental treatments in a sample of European Union (EU) Member States.

Materials And Methods: A questionnaire with open-ended questions was sent to oral health policy-makers in Denmark, England, France, Germany, Hungary, Ireland, Italy, the Netherlands, Poland, Romania, Scotland and Spain. They were asked to answer questions on the probable costs and provision of treatment in their country for a vignette presented as a pre-defined case.

Results: All respondents returned answers to all questions. Wide variations were reported in: who would deliver care, cost of items of care and total cost. For example, in France, only a dentist would provide the treatment. In Denmark, England, Germany, Ireland, Italy, the Netherlands and Scotland, it was likely that the treatment would be provided by a combination of dentist, dental hygienist and dental nurse. Fees ranged from €72 in England (if treated within the NHS) to €603 in Denmark. In Italy, Spain and for most patients in Romania, all treatment costs were paid by the patient. In the other nine countries, some subsidy from public funds was available. In terms of percentage of per capita Gross National Income, the cost to the patient ranged from 0.12% in France to 1.57% in Spain.

Conclusions: It was apparent that there are wide variations between EU Member States in the manner in which oral healthcare is delivered, its cost and the extent to which the cost of treatment is subsidised from state funds or through private insurance.
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http://dx.doi.org/10.1111/idj.12437DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6585721PMC
April 2019

Consumption frequency of added sugars and UK children's dental caries.

Community Dent Oral Epidemiol 2018 10 20;46(5):457-464. Epub 2018 Aug 20.

School of Dentistry, University of Leeds, Leeds, UK.

Objectives: To examine the association between consumption frequency of foods and drinks with added sugar and dental caries experience in the permanent teeth of 12- and 15-year-old children in England, Wales and Northern Ireland, using the Children's Dental Health Survey 2013 (CDHS) data.

Methods: Four thousand nine hundred and fifty children aged 12 and 15 have the following information available: daily consumption frequency of foods and drinks with added sugar, tooth-brushing frequency, dental attendance, and water-drinking frequency. The children's dental caries experience was available as a DMFT score (number of decayed, missing, filled permanent teeth). A zero-inflated negative binomial model (ZINB) was used to fit the DMFT score.

Results: Lower socioeconomic status (SES), nonregular dental check-ups, and low water-drinking frequency were associated with higher consumption frequency of added sugar (all P < 0.05). The consumption frequency of both drinks and foods with added sugar also differed by region (P < 0.001), and children who more frequently consumed foods with added sugars also consumed drinks with added sugars more often (P < 0.001). Using the Zero-Inflated Negative Binomial model, DMFT scores were not associated with consumption frequency of added sugars for children with caries (DMFT > 0), but the chance of being free of obvious caries (DMFT = 0) was lower for children with high frequency (≥4) of sugar-added foods than for children reported to have a sugar-free diet (OR = 0.5, 95% CI [0.3, 0.8]).

Conclusions: Consumption frequency of added sugars was associated with dental caries and a number of child demographic and lifestyle characteristics. Children who consume foods and drinks with added sugar more frequently are more likely to develop dental caries, but higher consumption frequency of drinking water in fluoridated areas might reduce dental caries. The findings add to the evidence for the association between children's dental caries and added sugar consumption.
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http://dx.doi.org/10.1111/cdoe.12413DOI Listing
October 2018

Knowledge, attitude and practice among Health Visitors in the United Kingdom toward children's oral health.

Public Health Nurs 2018 01;35(1):70-77

The Leeds School of Dentistry, The University of Leeds, Leeds, UK.

Objectives: The purpose of this study was to determine knowledge, attitude, and practical behavior of health visitors regarding children's oral health in the United Kingdom (UK).

Methods: A web-based self-administered survey with 18 closed and 2 open ended questions was distributed to a convenience sample of approximately 9,000 health visitors who were currently employed in the United Kingdom and a member of the Institute of Health Visiting.

Results: A total of 1,088 health visitors completed the survey, resulting in a response rate of 12%. One-third of the health visitors reported that they had not received oral health training previously. Almost all agreed that oral health advice/promotion should be included in their routine health visiting contacts. Previous oral health training/education was associated with an increase in oral health knowledge; confidence in entering a discussion with parents/caregivers and willingness to be involved in dental referral process.

Conclusions: The results of our study support the need for health visitors to receive oral health training in oral health promotion including oral health risk assessment, guidance on evidence based up-to-date prevention measures, increasing the dental attendance prevalence at early stages and awareness of including specific oral health guidelines/fact sheets into their regular practice.
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http://dx.doi.org/10.1111/phn.12381DOI Listing
January 2018

A qualitative study of patients' views of techniques to reduce dental anxiety.

J Dent 2017 Nov 31;66:45-51. Epub 2017 Aug 31.

School of Dentistry, University of Leeds, Leeds, UK. Electronic address:

Objectives: To explore the fear/anxiety inducing triggers associated with dental treatment, and what dentally anxious adults would like from their dental encounter.

Methods: Two focus-groups and three interviews with fourteen dentally-anxious people were conducted in this qualitative study. All discussions were tape-recorded and transcribed verbatim. Content was categorised by common characteristics to identify underlying themes using thematic analysis.

Results: Four themes were identified to bring general meaning within the content: 1. Preparedness, 2. Teamwork, 3. Reinforced trust, 4. Tailored treatment plan.

Conclusions: Preparatory information may need to be tailored and comprehensive, yet dissociative and reassuring. Dentally-anxious people might want a sense of control and shared-decision making. They may not want dentists to understate the treatment procedures and risks to make them feel better temporarily.

Clinical Significance: Dental anxiety affects between 10 and 60% of the population. Participants in this study suggested different ways the dental team could help their anxiety. Therefore, it is key for whole dental team to find out what could be done to help dentally anxious patients.
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http://dx.doi.org/10.1016/j.jdent.2017.08.012DOI Listing
November 2017

Factors that influence delivery of tobacco cessation support in general dental practice: a narrative review.

J Public Health Dent 2017 Dec 29;77(1):47-53. Epub 2016 Aug 29.

Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.

Objectives: To review the literature reporting factors that are associated with the delivery of lifestyle support in general dental practice.

Methods: A systematic review of the quantitative observational studies describing activities to promote the general health of adults in primary care general dental practice. Behavior change included tobacco cessation, alcohol reduction, diet, weight management, and physical activity. Tooth brushing and oral hygiene behaviors were excluded as the focus of this review was on the common risk factors that affect general health as well as oral health.

Results: Six cross sectional studies met the inclusion criteria. Five studies only reported activities to support tobacco cessation. As well as tobacco cessation one study also reported activities related to alcohol usage, physical activity, and Body Mass Index. Perceptions of time availability consistently correlated with activities and beliefs about tobacco cessation, alongside the smoking status of the dental professional. Dentists who perceive having more available time were more likely to discuss smoking with patients, prescribe smoking cessation treatments and direct patients toward (signpost to) lifestyle support services. Dental professionals who smoke were less likely to give smoking cessation advice and counselling than nonsmokers. Finally, the data showed that professional support may be relevant. Professionals who work in solo practices or those who felt a lack of support from the wider professional team (peer support) were more likely to report barriers to delivering lifestyle support.

Conclusion: Organizational changes in dental practices to encourage more team working and professional time for lifestyle support may influence delivery. Dental professionals who are smokers may require training to develop their beliefs about the effectiveness of smoking cessation interventions.
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http://dx.doi.org/10.1111/jphd.12170DOI Listing
December 2017

Using High Fluoride Concentration Products in Public Policy: A Rapid Review of Current Guidelines for High Fluoride Concentration Products.

Caries Res 2016 22;50 Suppl 1:50-60. Epub 2016 Apr 22.

University of Leeds School of Dentistry, Leeds, UK.

Despite improvements in dental caries levels since the widespread introduction of fluoride toothpastes, it is still a disease which is considered to be a priority in many countries around the world. Individuals at higher risk of caries can be targeted with products with a high fluoride concentration to help reduce the amount and severity of the disease. This paper compares guidance from around the world on the use of products with a high fluoride concentration and gives examples of how guidance has been translated into activity in primary care dental practice. A rapid review of electronic databases was conducted to identify the volume and variation of guidance from national or professional bodies on the use of products with a high fluoride concentration. Fifteen guidelines published within the past 10 years and in English were identified and compared. The majority of these guidelines included recommendations for fluoride varnish use as well as for fluoride gels, while a smaller number offered guidance on high fluoride strength toothpaste and other vehicles. Whilst there was good consistency in recommendations for fluoride varnish in particular, there was sometimes a lack of detail in other areas of recommendation for other vehicles with a high fluoride concentration. There are good examples within the UK, such as the Childsmile project and Delivering Better Oral Health, which highlight that the provision of evidence-based guidance can be influential in directing scarce resources towards oral health improvements. Policy can be influenced by evidence-based national recommendations and used to help encourage dental professionals and commissioners and third-party payers to adopt higher levels of practices aimed at oral health improvement.
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http://dx.doi.org/10.1159/000443409DOI Listing
October 2017

INVESTIGATING THE MANAGEMENT OF CARIOUS PRIMARY TEETH IN GENERAL DENTAL PRACTICE: AN OVERVIEW OF THE DEVELOPMENT AND CONDUCT OF THE FICTION TRIAL.

Prim Dent J 2015 Nov;4(4):67-73

The management of carious primary teeth is a challenge for patients, parents and clinicians. Most evidence supporting different management strategies originates from a specialist setting and therefore its relevance to the primary care setting is questionable. The UK National Institute for Health Research (NIHR) Health Technology Assessment (HTA) has commissioned the FiCTION (Filling Children's Teeth: Indicated Or Not?) trial; a multi-centre primary dental care randomised controlled trial (RCT) to determine the most clinically and cost- effective approach to managing caries in the primary dentition in the UK. This large trial began in 2012, is due to be completed in late 2017 and involves 72 practices and 1,124 children initially aged three to seven years with dentine caries, following randomisation to one of three caries management strategies. Clinical, radiographic, quality of life, treatment acceptability and health economics data are collected during the three-year follow up period. This article provides an overview of the development and conduct of FiCTION and discusses some approaches adopted to manage challenges and achieve the patient recruitment target.
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http://dx.doi.org/10.1308/205016815816682146DOI Listing
November 2015

The cost-effectiveness of smoking cessation services provided by general dental practice, general medical practice, pharmacy and NHS Stop Smoking Services in the North of England.

Community Dent Oral Epidemiol 2016 Apr 24;44(2):119-27. Epub 2015 Sep 24.

Academic Unit of Health Economics, The University of Leeds, Leeds, UK.

Objectives: To compare the cost-effectiveness of smoking cessation services in general dental practice (dental), general medical practice (GMP), pharmacy and NHS Stop Smoking Services (NHS SSS) from the perspective of the provider and the perspective of the NHS.

Methods: Retrospective monitoring data from NHS Bradford were accessed for any client attending a smoking cessation advisor within one of four commissioned smoking cessation services delivered by and within dental, GMP, pharmacy and NHS SSS (July 2011-December 2011). The treatment outcome of interest was 'quits' (effectiveness), and costs were assessed using incremental cost-effectiveness ratios (ICER) which compared each service setting against usual care (NHS SSS). All data were analysed using SPSS 19.

Results: For verified quits, only pharmacy services showed a lower mean cost per client and a higher proportion of CO verified quits than the other services. For both verified and self-reported quits dental services showed a slightly higher proportion of quits than NHS SSS; however, the mean cost per client was higher (£278.38 for an increase in quits of 1%). The GMP services were dominated by the NHS SSS, in as much as they were both less effective (a smaller proportion of quits and more expensive). This finding also holds true when we compared GMP services and pharmacy services.

Conclusions: From the perspective of the service provider and the NHS, the service considered to be 'cost-effective' when compared with 'usual care' (NHS SSS) was pharmacy services. This research has identified variations in service costs and effectiveness of services through the analysis of a pragmatic data set. Given the exploratory nature of this research, further research should explore the impact of service/location selection on uptake and cessation rates.
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http://dx.doi.org/10.1111/cdoe.12195DOI Listing
April 2016

The INCENTIVE protocol: an evaluation of the organisation and delivery of NHS dental healthcare to patients-innovation in the commissioning of primary dental care service delivery and organisation in the UK.

BMJ Open 2014 Sep 17;4(9):e005931. Epub 2014 Sep 17.

Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.

Introduction: In England, in 2006, new dental contracts devolved commissioning of dental services locally to Primary Care Trusts to meet the needs of their local population. The new national General Dental Services contracts (nGDS) were based on payment for Units of Dental Activity (UDAs) awarded in three treatment bands based on complexity of care. Recently, contract currency in UK dentistry is evolving from UDAs based on volume and case complexity towards 'blended contracts' that include incentives linked with key performance indicators such as quality and improved health outcome. Overall, evidence of the effectiveness of incentive-driven contracting of health providers is still emerging. The INCENTIVE Study aims to evaluate a blended contract model (incentive-driven) compared to traditional nGDS contracts on dental service delivery in practices in West Yorkshire, England.

Methods And Analysis: The INCENTIVE model uses a mixed methods approach to comprehensively evaluate a new incentive-driven model of NHS dental service delivery. The study includes 6 dental surgeries located across three newly commissioned dental practices (blended contract) and three existing traditional practices (nGDS contracts). The newly commissioned practices have been matched to traditional practices by deprivation index, age profile, ethnicity, size of practice and taking on new patients. The study consists of three interlinked work packages: a qualitative study to explore stakeholder perspectives of the new service delivery model; an effectiveness study to assess the INCENTIVE model in reducing the risk of and amount of dental disease and enhance oral health-related quality of life in patients; and an economic study to assess cost-effectiveness of the INCENTIVE model in relation to clinical status and oral health-related quality of life.

Ethics And Dissemination: The study has been approved by NRES Committee London, Bromley. The results of this study will be disseminated at national and international conferences and in international journals.
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http://dx.doi.org/10.1136/bmjopen-2014-005931DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4166246PMC
September 2014

The FiCTION dental trial protocol - filling children's teeth: indicated or not?

BMC Oral Health 2013 Jun 1;13:25. Epub 2013 Jun 1.

Background: There is a lack of evidence for effective management of dental caries (decay) in children's primary (baby) teeth and an apparent failure of conventional dental restorations (fillings) to prevent dental pain and infection for UK children in Primary Care. UK dental schools' teaching has been based on British Society of Paediatric Dentistry guidance which recommends that caries in primary teeth should be removed and a restoration placed. However, the evidence base for this is limited in volume and quality, and comes from studies conducted in either secondary care or specialist practices. Restorations provided in specialist environments can be effective but the generalisability of this evidence to Primary Care has been questioned. The FiCTION trial addresses the Health Technology Assessment (HTA) Programme’s commissioning brief and research question “What is the clinical and cost effectiveness of restoration caries in primary teeth, compared to no treatment?” It compares conventional restorations with an intermediate treatment strategy based on the biological (sealing-in) management of caries and with no restorations.

Methods/design: This is a Primary Care-based multi-centre, three-arm, parallel group, patient-randomised controlled trial. Practitioners are recruiting 1461 children, (3-7 years) with at least one primary molar tooth where caries extends into dentine. Children are randomized and treated according to one of three treatment approaches; conventional caries management with best practice prevention, biological management of caries with best practice prevention or best practice prevention alone. Baseline measures and outcome data (at review/treatment during three year follow-up) are assessed through direct reporting, clinical examination including blinded radiograph assessment, and child/parent questionnaires. The primary outcome measure is the incidence of either pain or infection related to dental caries. Secondary outcomes are; incidence of caries in primary and permanent teeth, patient quality of life, cost-effectiveness, acceptability of treatment strategies to patients and parents and their experiences, and dentists’ preferences.

Discussion: FiCTION will provide evidence for the most clinically-effective and cost-effective approach to managing caries in children's primary teeth in Primary Care. This will support general dental practitioners in treatment decision making for child patients to minimize pain and infection in primary teeth. The trial is currently recruiting patients.

Trial Registration: Protocol ID: NCTU: ISRCTN77044005.
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http://dx.doi.org/10.1186/1472-6831-13-25DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3698078PMC
June 2013

The management of dental caries in primary teeth - involving service providers and users in the design of a trial.

Trials 2012 Aug 22;13:143. Epub 2012 Aug 22.

School of Clinical Dentistry, Claremont Crescent, Sheffield, S10 2TA, UK.

Background: There is a lack of evidence for the effective management of dental caries in children's primary teeth. The trial entitled 'Filling Children's Teeth: Indicated Or Not?' (FiCTION) was designed to examine the clinical and cost effectiveness, in primary dental care, of three different approaches to the management of caries in primary teeth. However, before the FiCTION main trial commenced, a pilot trial was designed. Service provider (dentists and other members of the team including dental nurses and practice managers) and participant (child participants and their parents) involvement was incorporated into the pilot trial. The aim of this study is to describe service providers' and users' perspectives on the pilot trial to identify improvements to the conduct and design of the FiCTION main trial.

Methods: Qualitative interviews (individual and group) were held with dentists, dental team members, children and parents involved in the FiCTION pilot trial. Individual interviews were held with four dentists and a group interview was held with 17 dental team members. Face-to-face interviews were held with four parents and children (four- to eight-years old) representing the three arms of the trial and five telephone interviews were conducted with parents. All interviews were transcribed verbatim. Framework analysis was used.

Results: Overall, service providers, children and parents found the pilot trial to be well conducted and an interesting experience. Service providers highlighted the challenges of adhering to research protocols, especially managing the documentation and undertaking new clinical techniques. They indicated that the time and financial commitments were greater than they had anticipated. Particular difficulties were found recruiting suitable patients within the timeframe. For parents recruitment was apparently more related to trusting their dentist than the content of information packs. While some of the older children understood what a study was, others did not understand or were not aware they were enrolled.

Conclusions: The findings provided valuable recommendations to improve the method of recruitment of dental practices and patients, the timing and content of the training, the type of support dentists would value and ways to further engage children and parents in the FiCTION main trial.

Trial Registration: ISRCTN77044005.
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http://dx.doi.org/10.1186/1745-6215-13-143DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3487973PMC
August 2012

The feasibility of data collection in dental practices, using codes for the International Caries Detection and Assessment System (ICDAS), to allow European general dental practitioners to monitor dental caries at local, national, and international levels.

Prim Dent Care 2011 Apr;18(2):83-90

Dental Health Services & Research Unit, Dundee, Scotland, UK.

Aim: To determine whether or not European general dental practitioners can carry out comprehensive dental caries assessments of the teeth of selected quotas of their patients during routine dental check-ups, as an alternative or complement to the work of specialised, salaried, dental epidemiologists.

Methods: Dentists from several European countries were invited by local coordinators to be trained to carry out dental disease assessments. For caries, they used the International Caries Detection and Assessment System (ICDAS), as part of a wider oral health indicators project with a European perspective. They attended training events and recruited and examined patients in their own practices before completing questionnaires, which they returned to a central data-processing facility.

Results: Ninety-six dentists returned questionnaires giving their opinions of the data-collection system after performing ICDAS assessments on 1216 patients. Mean times for assessments varied between countries from 7.8 to 14.06 minutes and were dependent on the age of the patient and the number and general condition of the teeth present. Given a choice of six difficulty/ease options for both understanding and applying the system, 89% of the dental examiners chose one of the two categories indicating the least difficulty for understanding and 73% chose one of these two categories for applying.

Conclusion: Volunteer general dental practitioners (GDPs) from six European countries were able successfully to perform data collection for survey work in addition to their routine practice. If larger numbers of GDPs across Europe are prepared to undertake this type of work for selected quota samples, it should be possible to collect data to monitor caries levels among patients who attend dental practices at local, national, and international levels, provided that the time taken is considered and remunerated appropriately.
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http://dx.doi.org/10.1308/135576111795162875DOI Listing
April 2011