Publications by authors named "Jeffery L Milleman"

36 Publications

Safety and efficacy of a novel toothbrush utilizing RF energy for the reduction of plaque, calculus and gingivitis.

Am J Dent 2020 Jun;33(3):151-156

Salus Research, Fort Wayne, IN, USA.

Purpose: To evaluate the safety and efficacy of the ToothWave radiofrequency (RF) toothbrush in the reduction of plaque, calculus and gingival inflammation, as compared to a standard powered toothbrush accepted by the American Dental Association (ADA).

Methods: This was a single-blind, double arm, prospective study. Subjects were randomized to one of two treatment groups, receiving either the RF powered toothbrush or a control powered toothbrush, and performing twice daily brushing for a test period of 6 weeks. Plaque (RMNPI), calculus (V-MI), gingival inflammation (MGI) and bleeding (GBI) were assessed at baseline, after 4 and 6 weeks. Comparisons were completed both within and between each treatment group. Statistical analyses were conducted using the Mann Whitney non-parametric model.

Results: 85 subjects completed the study and had fully evaluable data. No significant differences between the groups were found in the baseline scores (P≥ 0.165). Following 6 weeks, the RF test group demonstrated statistically significant reductions in plaque, gingivitis and calculus compared to the control powered toothbrush (P≤ 0.001). Both toothbrushes were well-tolerated and no device-related adverse events were reported. The RF-utilizing powered toothbrush produced statistically significant reductions in dental plaque, calculus deposition, gingival inflammation and gingival bleeding as compared to a control powered toothbrush.

Clinical Significance: The RF powered toothbrush used twice daily resulted in an overall improvement in oral health.
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June 2020

A randomized clinical study to evaluate the effect of denture adhesive application technique on food particle accumulation under dentures.

Clin Exp Dent Res 2019 08 17;5(4):316-325. Epub 2019 Jun 17.

Salus Research Inc. Fort Wayne Indiana USA.

Food ingress under dentures is a common problem that may be reduced by denture adhesive use. The objective of this study was to explore the effect of the mode of application of a denture adhesive on reducing accumulation of food particles under dentures. This was a single-centre, controlled, single-blind, randomized, three-treatment, three-period, crossover study in participants with complete, removable well-fitting, well-made upper/lower dentures. Treatments were: 1) experimental denture adhesive application (test adhesive) applied with a precision applicator as continuous strips; 2) marketed denture adhesive (positive control) applied using a flat ribbon nozzle as dabs; 3) no adhesive. Food-occlusion testing was performed by assessing peanut particle migration under dentures with denture retention/stability evaluated using the Kapur Index (Olshan modification). Differences were assessed using an ANOVA model. Adhesive oozing and perceptions of the adhesives were assessed by questionnaire. All 83 randomized participants completed the study. There were no significant differences between positive control or test adhesives versus no adhesive, or between test adhesive and positive control, for mass of peanut particles recovered from dentures. Both adhesives had significantly higher retention and stability scores compared with no adhesive (all  < .01). Participants reported significantly higher scores for denture comfort, confidence, satisfaction and movement with both adhesives versus no adhesive (all  < .01). No differences in adhesive ooze were reported between adhesives. No adverse events were reported. In conclusion, there was no difference in performance, as measured by peanut particle mass recovered from upper/lower dentures, for the test adhesive, positive control and no adhesive.
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http://dx.doi.org/10.1002/cre2.168DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6704053PMC
August 2019

Stain control with two experimental dentin hypersensitivity toothpastes containing spherical silica: a randomised, early-phase development study.

BDJ Open 2019 6;5. Epub 2019 Jun 6.

Salus Research, 1220 Medical Park Drive, Fort Wayne, IN 46825 USA.

Aims: To determine in human participants whether toothpastes containing small quantities of a novel spherical silica, added to provide enhanced cleaning properties, could achieve similar or greater extrinsic dental stain removal compared to toothpastes containing standard dental abrasive silica concentrations.

Materials And Methods: One hundred and twenty-three adults with extrinsic dental stain were randomised to one of four parallel groups for 8 weeks' twice-daily brushing with an experimental toothpaste containing either 0.5% or 1% spherical silica (with relative dentin abrasivity [RDA] of ~38 and ~58, respectively), or marketed toothpastes containing either 6% (RDA ~ 36) or 16% (RDA ~ 166) standard abrasive silica. The objective was to evaluate the ranking order in extrinsic dental stain removal at Week 8, as measured by MacPherson modification of Lobene stain index Area × Intensity.

Results: Small treatment differences were observed between toothpaste formulations. The ranking order in extrinsic dental stain removal was: experimental 1% spherical silica toothpaste >16% standard abrasive silica toothpaste >6% standard abrasive silica toothpaste >experimental 0.5% spherical silica toothpaste. Toothpastes were generally well tolerated.

Conclusion: This early-phase development study suggests that toothpaste formulations with low concentrations of a novel spherical silica abrasive with high-cleaning capability are generally well tolerated and appropriate for further development.
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http://dx.doi.org/10.1038/s41405-019-0016-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6554270PMC
June 2019

A Comparison of the Effects of a Powered and Manual Toothbrush on Gingivitis and Plaque: A Randomized Parallel Clinical Trial.

J Clin Dent 2019 Mar;30(Spec No A):A24-29

Salus Research, Fort Wayne, IN, USA.

Objectives: To compare the effect of a powered and a manual toothbrush on gingivitis and plaque following two and four weeks of home use.

Methods: This was a randomized, parallel-design, single-blind clinical trial. Eligible participants were generally healthy non-smoking manual toothbrush users aged 18-65 years, with a plaque score of = 1.8 per Lobene and Soparkar Modified Plaque Index (MPI) following a 3-6 hour plaque accumulation period, and mild to moderate gingivitis defined as a Gingival Bleeding Index (GBI) = 1 on at least 20 sites. Subjects with advanced periodontal disease, xerostomia, excessive gingival recession, uncontrolled diabetes, and heavy deposits of calculus or rampant decay were excluded. Enrolled participants were randomly dispensed either a Philips Sonicare powered toothbrush used with the InterCare brush head (PTB) or an American Dental Association (ADA) reference manual toothbrush (MTB). Efficacy and safety variables were assessed at Baseline, and at two and four weeks following twice-daily product home use. The primary endpoint of the study was reduction of gingivitis per the Modified Gingival Index (MGI) after four weeks of home use.

Results: All 148 randomized subjects (74 per group) completed the study. A statistically significant difference in MGI reduction was observed between the two study groups (p < 0.001). The least square (LS) mean and standard error reduction from Baseline was 0.72 (0.04) for the PTB group compared to 0.09 (0.04) for the MTB group. Expressed as percent reduction from Baseline, the LS mean values were 35.77% (2.19%) and 4.22% (2.19%) for PTB and MTB, respectively. Statistically significant differences were also observed for MGI reduction at Week 2, as well as for MPI and GBI reduction at Weeks 2 and 4.

Conclusions: The powered toothbrush was statistically significantly superior to a manual toothbrush in reducing gingival inflammation, gingival bleeding, and plaque following two and four weeks of home use.
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March 2019

A Randomized Parallel Study to Compare the Effects of Powered and Manual Tooth Brushing on Gingival Health and Plaque.

J Clin Dent 2019 Mar;30(Spec No A):A16-23

Salus Research, Fort Wayne, IN, USA.

Objectives: To compare the effect of powered and manual tooth brushing on plaque and gingivitis following two and six weeks of home use.

Methods: This was a randomized, three-arm, parallel-design clinical trial. Eligible participants were manual toothbrush users who were generally healthy non-smokers, aged 18-65 years, with a plaque score of = 1.8 per Lobene and Soparkar Modified Plaque Index (MPI), and mild to moderate gingivitis, defined as a Gingival Bleeding Index (GBI) = 1 on at least 20 sites. Subjects with advanced periodontal disease, excessive gingival recession, and heavy deposits of calculus or rampant decay were excluded. Enrolled participants were randomly dispensed one of three devices: a powered toothbrush (Philips Sonicare DiamondClean Smart with Premium Gum Care brush head) used in either Gum Heath mode (DC-GH) or Clean mode (DC-C), or an ADA reference manual toothbrush (MTB). Efficacy and safety variables were assessed at Baseline, and at two and six weeks following twice-daily product home use.

Results: For the primary endpoint, reduction in gingivitis per Modified Gingival Index (MGI) at Week 2, 188 subjects completed and were included in the analysis. Expressed as percent reduction from Baseline, the adjusted mean reduction and Standard Error (SE) estimates were 60.31% (1.95%) for DC-GH, 53.08% (1.95%) for DC-C, and 16.59% (1.96%) for MTB. The difference between each power toothbrush group and the manual toothbrush was statistically significant (p < 0.0001). Statistically significant differences were also observed between DC-GH, DC-C, and manual tooth brushing for MGI at Week 6, as well as for MPI and GBI at Weeks 2 and 6.

Conclusions: The powered toothbrush, used in either Gum Health or Clean mode, was statistically significantly superior to a manual tooth brush in reducing gingival inflammation, gingival bleeding, and plaque following two and six weeks of home use.
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March 2019

The Effects of Use of a Powered and a Manual Home Oral Hygiene Regimen on Plaque and Gum Health in an Orthodontic Population.

J Clin Dent 2019 Mar;30(Spec No A):A1-8

Salus Research, Fort Wayne, IN, USA.

Objectives: The objective of this study was to compare the effect of two home use oral hygiene regimens on plaque, gingivitis, and gingival bleeding on subjects undergoing orthodontic treatment with fixed appliances.

Methods: This was a randomized, parallel, single-center clinical trial. Eligible study subjects fit the following profile: age 12-65 years; nonsmoker; plaque score of = 2.0 per Bonded Bracket Index (BBI) on dentition with fixed orthodontic hardware; minimum of 10 orthodontic brackets in each arch or on all teeth from first molar to first molar; presenting with mild to moderate gingivitis, defined as a score of = 1 on at least 20 sites per Gingival Bleeding Index (GBI). Subjects with advanced periodontal disease or gingival recession were not eligible. Eligible subjects were randomized to one of two home use oral hygiene regimens: manual toothbrush plus string floss (used with a threading device) for interdental cleaning (MTF regimen); or Philips Sonicare EasyClean power toothbrush with InterCare brush head and AirFloss Pro powered device, used with BreathRx mouthrinse for interdental cleaning (Sonicare Orthodontic Regimen or SOR). All subjects brushed twice daily with standard fluoridated dentifrice and performed interdental cleaning once daily. Efficacy and safety examinations were performed at Baseline and following three and six weeks of home use of the study products, and included assessments of BBI, GBI, Modified Gingival Index (MGI), and Modified Plaque Index (MPI).

Results: Of 228 enrolled subjects, 223 were included in the primary analysis. For the primary endpoint, reduction in BBI score following three weeks of product use, the overall least squares (LS) mean (95% CI) reduction was 0.89 (0.84, 0.95) for SOR and 0.06 (0.01, 0.12) for MTF. Expressed as percent reduction (95% CI) from Baseline, this was 33.1% (31.1%, 35.2%) for SOR and 2.01% (-0.06%, 4.07%) for MTF. The differences between regimens were statistically significant, p < 0.0001. Statistically significant differences between regimens were observed in BBI following six weeks of product use, and also for all other efficacy variables (GBI, MGI, MPI) at Week 3 and Week 6.

Conclusions: The powered oral hygiene regimen was significantly more effective than a manual regimen in reducing plaque on bracketed and non-bracketed teeth, and in reducing gingival bleeding and gingival inflammation in orthodontic subjects following three weeks of use and persisting following six weeks of use. All products were safe on oral tissues and fixed orthodontic appliances.
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March 2019

Efficacy of a 3% potassium nitrate mouthrinse for the relief of dentinal hypersensitivity: An 8-week randomized controlled study.

J Am Dent Assoc 2019 03;150(3):204-212

Background: Mouthrinses containing potassium salts have been shown to be effective for the relief of dentinal hypersensitivity (DH) when used adjunctively to toothbrushing with a nonsensitivity toothpaste.

Methods: The authors conducted a randomized, 8-week, single-center, examiner-blinded, parallel-group clinical trial with 191 participants with DH. Participants were randomized to twice-daily use of either 3% potassium nitrate (KNO) mouthrinse plus fluoride toothpaste or the same fluoride toothpaste alone. The primary outcome was change from baseline in response to an evaporative (air) stimulus at 8 weeks, measured using the Schiff sensitivity scale. Secondary outcomes were response to an evaporative (air) stimulus with the Schiff sensitivity scale (4 weeks) and a visual rating scale (4 and 8 weeks) and response to a tactile stimulus (4 and 8 weeks).

Results: Both groups showed statistically significant improvements in evaporative (air) sensitivity from baseline after 4 and 8 weeks (P < .0001). At weeks 4 and 8, the authors observed significant improvements from baseline in tactile sensitivity only in the KNO mouthrinse group (P < .0001). Between-treatment comparisons for all sensitivity measures at both time points showed statistically significantly greater DH reductions in the KNO mouthrinse group compared with the toothpaste-alone group (P = .0004 for the visual rating scale at week 4; P < .0001 for all other measures and time points). Treatments were generally well tolerated.

Conclusions: Twice-daily use of a 3% KNO mouthrinse, adjunctive to toothbrushing with fluoride toothpaste, provided significant improvements in DH compared with fluoride toothpaste alone.

Practical Implications: Addition of 3% KNO mouthrinse to a typical oral hygiene regimen of toothbrushing with fluoride toothpaste provides an alternative strategy for the management of DH. ClinicalTrials.gov: NCT02226562.
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http://dx.doi.org/10.1016/j.adaj.2018.10.023DOI Listing
March 2019

Randomized Controlled Clinical Study to Determine the Oral and Dermal Tolerability of an Experimental Denture Wipe.

J Prosthodont 2019 Feb 28;28(2):138-145. Epub 2018 Nov 28.

Salus Research Inc., Fort Wayne, IN.

Purpose: To evaluate oral and dermal tolerance following use and user acceptability of an experimental denture-cleansing wipe. An exploratory objective was to develop a method to assess denture wipe effectiveness in removing debris from denture surfaces.

Materials And Methods: This was a single-center, randomized, controlled, parallel-group, examiner-blind study in participants with ≥1 full/partial denture. Participants were randomized to clean their dentures with the denture wipe (n = 76) or water (n = 76) up to 4 times per day for 14 days. Tolerability was assessed by treatment-emergent adverse events (TEAEs), oral soft tissue examination, and lead hand dermatological assessment. Acceptability was assessed by questionnaire. The feasibility of a methodology to assess the efficacy of the wipe at removing food particles was also evaluated through determination of the mass of chewed peanut particles that the wipe removed after a single use (n = 31).

Results: The proportion of participants experiencing oral TEAEs by day 14 was 0.039% with the denture wipe (lip injury [n = 1], mouth injury [n = 2]) and 0.013% with the water rinse (coated tongue [n = 1]). There were no dermal TEAEs and no TEAE-related study withdrawals. Skin irritation scores with the denture wipe remained unchanged from baseline. Comparing before vs. after cleaning with the denture wipe, a higher proportion of participants rated their dentures as feeling extremely/very fresh (28.9% pre-/85.5% post-cleaning), feeling extremely/very clean (34.2%/86.8%) and looking extremely/very clean (43.5%/85.5%). More denture-wipe group participants than water-rinse group participants were extremely/very satisfied with the amount of debris removed from their dentures (88.1% vs 72.4%). The methodology used to assess the weight of peanut particles captured from the wipes/dentures appeared to be a feasible investigation technique.

Conclusions: The denture wipe was generally well-tolerated and had good user acceptability. The methodology for assessing the mass of peanut particles removed by denture wipes was successful.
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http://dx.doi.org/10.1111/jopr.12992DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7328799PMC
February 2019

Subgingival uptake and retention of stannous fluoride from dentifrice: Gingival crevicular fluid concentrations in sulci post-brushing.

Am J Dent 2018 Aug;31(4):184-188

Procter & Gamble, Mason, OH, USA.

Purpose: To examine the delivery of stannous fluoride to subgingival sulci following toothpaste use in a clinical population.

Methods: This was a controlled, single-site study. 23 subjects with at least 20 dental pockets, 2-4 mm with bleeding, who had not used a stannous fluoride dentifrice in the last 3 months were enrolled. After a 2-week washout period, 20 subjects returned for a baseline visit. They were instructed to refrain from brushing the night before the baseline visit. GCF samples were taken from up to 10 sites identified as sampling sites. Subjects were then given a 0.454% stannous fluoride dentifrice and soft manual toothbrush and asked to brush for 1 minute. 30 minutes after brushing, GCF was re-sampled. Subjects continued using the stannous fluoride dentifrice and soft manual toothbrush at home, twice daily for 2 weeks, in place of their usual hygiene products. At Days 1 and 14, subjects returned to the site, and 12 hours post-brushing GCF samples were taken. The samples were analyzed by ICP-MS (inductively coupled plasma mass spectrometry). A Wilcoxon signed-rank test was performed to determine the difference between post-baseline visits and baseline. Statistical tests were 2-sided using a 5% significance level.

Results: 20 subjects completed the trial. Significant levels of tin, a marker for stannous fluoride, were detected 30 minutes after brushing at sampling sites of 2-4 mm. The median tin level in gingival crevicular fluid (GCF) was 24.59 ng/µl, which was highly significant versus baseline (P< 0.0001). Tin levels sampled in GCF 12 hours after brushing on Days 1 and 14 were highly significant versus Baseline (P< 0.0001), showing an increasing trend with continued use.

Clinical Significance: Stannous fluoride was found to penetrate sampling sites from 2-4 mm and was retained for 12 hours. Subgingival uptake and retention of stannous fluoride following toothbrushing may play a role in detoxification effects on microbial biofilms and may contribute to the therapeutic efficacy of stannous fluoride dentifrices in promoting gingival health.
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August 2018

A randomised controlled trial to evaluate the plaque removal efficacy of sodium bicarbonate dentifrices in a single brushing clinical model.

BDJ Open 2018 4;4:17037. Epub 2018 Jun 4.

Salus Research, 1220-4 Medical Park Drive, Fort Wayne, IN 46825 USA.

Objective: To evaluate plaque removal efficacy of dentifrices containing sodium bicarbonate (NaHCO) compared with a non-NaHCO dentifrice after a single-timed brushing.

Materials And Methods: A randomised, controlled, examiner-blinded, four-period, crossover study in 56 adults with a mean whole-mouth plaque index of ≥2.00 (six site modification of Turesky modification of Quigley-Hein Plaque Index [TPI]). Subjects brushed once for one timed minute with a 67% NaHCO dentifrice with herbs; a 67% NaHCO dentifrice without herbs; a 62% NaHCO dentifrice with herbs; or a non-NaHCO dentifrice without herbs. All contained 923 p.p.m. fluoride as sodium fluoride. Pre- and post-brushing plaque assessments were performed.

Results: Mean TPI score decreased from pre- to post-brushing with all treatments. There were statistically significantly greater reductions in plaque for NaHCO dentifrices compared to non-NaHCO ( < 0.0001 for all) with no significant differences between NaHCO-containing dentifrices. A post hoc analysis of plaque removal from different oral areas showed statistically significant differences in favour of the NaHCO dentifrices over the non-NaHCO dentifrice for almost all surfaces. No adverse events were reported.

Discussion And Conclusion: Plaque removal was significantly greater with NaHCO-containing dentifrices compared with a non-NaHCO dentifrice after a single, timed brushing. There was no effect of herbal tinctures. This study was registered at ClincalTrials.org: NCT03285984.
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http://dx.doi.org/10.1038/s41405-018-0003-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5986814PMC
June 2018

Six-Month Evaluation of a Sodium Bicarbonate-Containing Toothpaste for Reduction of Established Gingivitis: A Randomized USA-Based Clinical Trial.

J Clin Dent 2018 Mar;29(1):33-39

Syneos Health, Thomas House, Maidenhead, Berkshire, UK.

Objectives: Short-term use of sodium bicarbonate (NaHCO3)-containing toothpaste reduces plaque and improves clinical measures of gingivitis. To examine this over a longer period, we compared efficacy and tolerability of twice-daily brushing for 24 weeks with 67% or 0% NaHCO3-containing toothpastes in USA-based participants with moderate gingivitis (Clinicaltrials.gov:NCT02207400).

Methods: This was a six-month, randomized, examiner-blind, parallel-group, clinical trial. Investigators randomized adults with blood in expectorate after brushing and ≥ 20 gingival bleeding sites to 67% NaHCO3 (n = 123; n = 107 completed study) or 0% NaHCO3 (n = 123; n = 109 completed study) toothpastes. Primary efficacy variables included between-treatment differences in number of bleeding sites and Modified Gingival Index (MGI) score at 24 weeks. Secondary efficacy variables included Bleeding Index and Turesky modification of the Quigley-Hein Plaque Index (overall and interproximal sites) at six, 12, and 24 weeks. A subset of 50 participants underwent sampling to assess plaque microbiology over the course of treatment.

Results: Compared with the 0% NaHCO3 toothpaste, the 67% NaHCO3 toothpaste produced statistically significant improvements at Week 24 in number of bleeding sites (46.7% difference) and MGI (33.9% difference), and for all other endpoints (all p < 0.0001). There was no significant between-treatment difference in the proportion of participants harboring opportunistic pathogens. Products were generally well tolerated, with two and five treatment-related adverse events reported in the 67% and 0% NaHCO3 toothpaste groups, respectively.

Conclusions: Gingival bleeding, gingivitis, and plaque indices were significantly improved at six, 12, and 24 weeks with twice-daily brushing with 67% NaHCO3-containing toothpaste in participants with moderate gingivitis.
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March 2018

An exploratory study to investigate stain build-up with long term use of a stannous fluoride dentifrice.

Am J Dent 2018 Apr;31(2):71-75

Salus Research, Fort Wayne, Indiana, USA.

Purpose: To monitor extrinsic stain formation over 24 weeks with twice-daily use of an anhydrous 0.454% SnF2 dentifrice containing 5% sodium tripolyphosphate (STP) ('Test'), compared to a standard fluoride dentifrice (0.76% fluoride as sodium monofluorophosphate [SMFP\) ('Comparator') following a professional prophylaxis.

Methods: Primary efficacy variables were between-treatment differences in extrinsic dental stain of anterior teeth after 4, 8, 12, and 24 weeks' use using mean area and intensity scores of the MacPherson modification of the Lobene stain index (MLSI), and to monitor oral tolerability.

Results: Overall, 214 subjects were randomized to treatment. The Test dentifrice group demonstrated statistically significantly less stain compared with the Comparator at each timepoint for all outcome variables (MLSI - Area × Intensity, Area only, and Intensity only) with the exception of MLSI (Area × Intensity) at Week 12. Products were generally well tolerated with 26 treatment-related adverse events (TRAEs) reported (10 with Test, 16 with Comparator). Five subjects withdrew from the 24-week study due to TRAEs, three in the Test group, two in the Comparator group. Statistically significantly less anterior tooth staining was observed with up to 24 weeks twice-daily brushing with a 0.454% SnF2/5% STP anhydrous dentifrice compared to a marketed fluoride dentifrice with 0.76% SMFP.

Clinical Significance: Long term use of a SnF2/STP dentifrice demonstrated minimal stain build-up after 24 weeks, twice-daily use; products were generally well-tolerated.
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April 2018

A randomized clinical trial to evaluate the stain removal efficacy of a sodium phytate dentifrice formulation.

J Esthet Restor Dent 2018 03 7;30(2):E45-E51. Epub 2018 Feb 7.

Salus Research, Fort Wayne, Indiana 46825.

Objectives: Phytate is an organic, cyclic polyphosphate analogous to linear condensed polyphosphates used as stain removal agents. This study investigated stain removal efficacy of an experimental sodium phytate-containing dentifrice compared to a reference dentifrice.

Methods: An experimental, moderate abrasivity (relative dentine abrasivity [RDA] ∼130) antisensitivity fluoride dentifrice containing sodium phytate (0.85% w/w as the hexasodium salt) (n = 111) was compared to a reference, marketed, low-abrasivity (RDA ∼ 43), anti-sensitivity fluoride dentifrice (n = 113), both containing 1150 ppm fluoride as sodium fluoride. Primary efficacy variables were between-treatment differences in extrinsic dental stain of anterior teeth after 6 and 12 weeks' twice-daily use, using Lobene stain index (MacPherson modification, MLSI) mean area (A) and intensity (I) scores. Comparisons included whole-tooth and hard-to-reach areas (gingival, interproximal, body of lingual).

Results: At both 6- and 12-week timepoints, MLSI (A × I) scores for total area and hard-to-reach areas for the experimental dentifrice were statistically significantly lower than baseline (P < .0001 for all). This was demonstrated for the reference dentifrice at 6 weeks only, for total, interproximal (P < .0001 for both), and body of lingual (P = .0395) scores. Compared with the reference, the experimental dentifrice had statistically significantly lower MLSI scores at both 6 and 12 weeks for all outcome variables including both total MLSI (A × I) and hard-to reach areas (P < .0001 in all cases). Products were generally well-tolerated.

Conclusions: Differences between treatments were considered clinically differentiable. Sodium phytate may therefore be a suitable additive ingredient to improve tooth stain control performance within an otherwise conventional dentifrice formulation.

Clinical Significance: Following 6 and 12 weeks brushing, clinically differentiable differences were shown in stain index scores with an experimental dentifrice containing sodium phytate compared to a reference dentifrice without sodium phytate. Sodium phytate may therefore be a suitable additive ingredient to improve tooth stain control performance within an otherwise conventional dentifrice formulation.
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http://dx.doi.org/10.1111/jerd.12355DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5969293PMC
March 2018

In Vitro and In Vivo Evaluations of the Anticalculus Effect of a Novel Stabilized Stannous Fluoride Dentifrice.

J Clin Dent 2017 Dec;28(4):B21-26

Salus Research Inc., Fort Wayne, IN, USA.

Objectives: To evaluate the effect of a novel stannous fluoride dentifrice with zinc citrate on calculus inhibition using both in vitro and clinical models.

Methods: Each investigation tested a novel stabilized 0.454% stannous fluoride dentifrice with zinc citrate as an anticalculus agent (Crest® Pro-Health™ smooth formula) compared to a negative control fluoride dentifrice. The in vitro study used the modified Plaque Growth and Mineralization Model (mPGM). Plaque biofilms were prepared and mineralized by alternate immersion of glass rods in human saliva and artificial mineralization solution. Treatments of 25% w/w dentifrice/water slurries were carried out for 60 seconds daily for 6 days, between saliva and mineralization solution immersions. Plaque calcium levels were determined by digestion and inductively coupled plasma optical emission spectroscopy. Student's t-test (p < 0.05) was used for statistical analysis. The clinical study was a parallel group, double-blind, randomized, and controlled trial. Following a dental prophylaxis, subjects entered a two-month run-in phase. At the end, they received a Volpe-Manhold Index (V-MI) calculus examination. Eighty (80) qualified subjects who had formed at least 9 mm of calculus on the linguals of the mandibular anterior teeth were re-prophied and randomly assigned to either the stannous fluoride dentifrice or the negative control. Subjects brushed twice daily, unsupervised, during the three-month test period, returning at Weeks 6 and 12 for safety and V-MI examinations. Statistical analyses were via ANCOVA.

Results: In vitro mPGM: The stabilized stannous fluoride dentifrice showed 20% less in vitro tartar formation, measured as calcium accumulation normalized by biofilm mass, versus the negative control (106.95 versus 133.04 µg Ca/mg biofilm, respectively, p < 0.05). Clinical Trial: Seventy-eight (78) subjects completed with fully evaluable data. The stannous fluoride dentifrice group had 15.1% less adjusted mean calculus at Week 6 compared to the negative control group (p = 0.05) and 21.7% less calculus at Week 12 (p < 0.01). Both dentifrices were well-tolerated.

Conclusions: The stannous fluoride dentifrice produced significant anticalculus benefits in vitro and in a clinical trial compared to a negative control.
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December 2017

An induced extrinsic tooth stain prevention model to investigate whitening potential of sugar-free chewing gums.

Am J Dent 2017 Dec;30(6):309-315

Howard M. Proskin & Associates, Rochester, NY, USA.

Purpose: To establish an accelerated clinical test method to evaluate the effectiveness of sugar-free gums in prevention of the formation of extrinsic stains when chewed over a 2-week period in conjunction with daily tooth brushing. A secondary objective was to compare three methods for measuring extrinsic stain.

Methods: 25 healthy adult volunteers were enrolled in a single center, examiner blind, randomized 4-way crossover clinical study. Starting with a stain-free baseline, subjects rinsed five times daily with freshly brewed black tea, followed either by chewing one of three different gums for 12 minutes or not chewing (negative control). Extrinsic stain was measured at 1 and 2 weeks by modified Lobene Stain Index (MLSI), digital imaging, and a Vita EasyShade spectrophotometer.

Results: At 2 weeks, MLSI scores showed a statistically significant mean reduction of 43% or greater versus no-gum control for all three gum treatments. Digital image analysis and Vita EasyShade measurement showed reductions of yellowness (measured by difference in ∆b* values between the three gums and the non-gum control treatment) ranging from 0.28 to 0.34 and 3.52 to 4.18 Δb* units, respectively, for subjects using the chewing gums versus no-gum control (P< 0.05) after 2 weeks. This clinical study demonstrated that sugar-free gum can effectively reduce new stain formation along with daily tooth brushing in as little as 2 weeks when used in conjunction with tea rinsing to help promote more rapid stain formation. All three test methods confirmed the results, albeit with different levels of statistical significance. A minor modification of gum base polymer, or change of flavors, did not significantly impact the prevention of new stain formation.

Clinical Significance: Regular consumption of sugar-free chewing gum helps prevent extrinsic dental stain accumulation and provides a simple and enjoyable means for consumers to maintain their natural tooth color.
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December 2017

Potassium oxalate oral rinses for long-term relief from dentinal hypersensitivity: Three randomised controlled studies.

J Dent 2018 03 11;70:23-30. Epub 2017 Dec 11.

Salus Research, Inc., 1220 Medical Park Drive Building #4, Fort Wayne, IN 46825, USA. Electronic address:

Objectives: To evaluate effectiveness of oral rinses containing dipotassium oxalate monohydrate (KOX) in relieving dentinal hypersensitivity (DH) after 8 w use adjunctive to brushing.

Methods: Three 8-week, randomised, controlled, double-blind, parallel-group, single-centre studies were conducted in adults with DH. In each study, participants were randomised to one of two experimental rinses or a placebo in a matrix design, such that each experimental rinse was evaluated in two studies. Rinses A (pH 4.5) and B (pH 7.0) contained 1.5% KOX and were fluoride-free; Rinse C (pH 4.5) contained 2.0% KOX and 45 ppm fluoride as NaF; the placebo rinse (pH 4.5) did not contain KOX or fluoride. Participants brushed with a fluoride dentifrice for 1 min, briefly rinsed with water, then rinsed with their assigned oral rinse for 1 min twice daily for 8 w. DH was assessed at baseline and following 4 and 8 w use by response to an evaporative (air) stimulus (evaluated by Schiff sensitivity score and a 10-point visual rating scale) and a tactile stimulus (Yeaple probe).

Results: All rinses in each study were associated with statistically significant improvements from baseline in measures of DH after 4 and 8 w treatment. However, between-treatment comparisons were inconsistent across the studies, with only Study 3 demonstrating a significant difference between the experimental (Rinses B and C) and placebo rinses. A number of treatment-related adverse events (all mild) were reported.

Conclusions: Rinses containing 1.5-2.0% KOX did not consistently demonstrate a benefit over placebo in relieving DH after 8 w use.

Clinical Significance: While favourable results were found in one of the investigations, this suite of studies shows that the possibility of inconsistent results exists even with the best designed and executed trials.
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http://dx.doi.org/10.1016/j.jdent.2017.12.004DOI Listing
March 2018

A randomized clinical study to evaluate the effect of an ultra-low abrasivity dentifrice on extrinsic dental stain.

Am J Dent 2017 Oct;30(5):255-261

Salus Research, Inc., Fort Wayne, Indiana, USA.

Purpose: To investigate the stain-removal efficacy of an experimental ultra-low abrasivity anti-sensitivity dentifrice containing sodium tripolyphosphate (STP) and a cocamidopropyl betaine/sodium methyl cocoyl taurate detergent system.

Methods: This was a single-center, examiner-blind, randomized, parallel-group study. Extrinsic dental stain was assessed on the facial surfaces of the six maxillary and six mandibular anterior teeth and the lingual surfaces of the six mandibular anterior teeth using the Macpherson modification of the Lobene Stain Index (MLSI). Treatments were: ultra-low abrasivity dentifrice [5% w/w KNO3, 5% w/w STP, 1,100 ppm fluoride as sodium fluoride; relative dentin abrasivity (RDA) ~10; n=54]; moderate abrasivity fluoride dentifrice (1,100 ppm fluoride as sodium monofluorophosphate; RDA ~68; n= 57); higher abrasivity daily-use whitening dentifrice (1,100 ppm fluoride as sodium fluoride; RDA~137; n= 57). Subjects brushed for 1 minute, twice daily, for 8 weeks.

Results: Mean total MLSI [ Area × Intensity (A×I) ] change from baseline score at Weeks 4 and 8 was significant (P< 0.0001) for all groups. At Week 8, for the ultra-low abrasivity dentifrice versus the moderate and higher abrasivity dentifrices, mean total MLSI (A×I) scores (P< 0.0001), along with MLSI endpoints in facial, lingual, and interproximal regions (P= 0.0035 to P< 0.0001), favored the ultra-low abrasivity dentifrice. Dentifrices were generally well-tolerated. The ultra-low abrasivity dentifrice containing 5% STP reduced extrinsic dental stain more effectively than moderate or higher abrasivity dentifrices.

Clinical Significance: The ultra-low abrasivity, anti-sensitivity dentifrice containing 5% STP reduced extrinsic dental stain more effectively than moderate or higher abrasivity dentifrices, and is thus suitable for patients with sensitive teeth who wish to control extrinsic dental stain.
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October 2017

Randomized Controlled Trial to Explore the Effect of Experimental Low Abrasivity Dentifrices on Enamel Gloss and Smoothness, and the Build-up of Extrinsic Tooth Stain.

J Clin Dent 2017 Jun;28(2):1-8

GSK Consumer Healthcare, Weybridge, Surrey, UK.

Objectives: To evaluate and compare examiner-assessed changes in enamel gloss, extrinsic dental stain, and surface smoothness following one, two, four, and eight weeks of twice-daily use of an experimental low abrasivity desensitizing dentifrice (relative dentin abrasivity [RDA] ~40) containing 5% sodium tripolyphosphate (STP) chemical cleaning agent and 1% aluminum trioxide abrasive. This was compared with an ultra-low abrasivity dentifrice (5% STP only; RDA ~13), a moderate abrasivity fluoride dentifrice (RDA ~80), and a higher abrasivity marketed whitening dentifrice (RDA ~142).

Methods: This was a single-center, examiner-blind, randomized, controlled, parallel group study in healthy adults stratified by gloss score and age. Following a washout period with a conventional silica abrasive dentifrice, subjects received a dental scale and polish and were randomized to treatment. Subjects brushed their teeth for two minutes, twice daily, with their assigned dentifrice. Enamel gloss was assessed visually by comparing the facial surfaces of the maxillary incisors to the Sturzenberger gloss standards. Extrinsic dental stain was measured on the 12 anterior teeth (facial and lingual) using the Macpherson modification of the Lobene Stain Index (MLSI). Tooth smoothness was assessed using scanning electron microscope (SEM) analysis of a silicone impression of the central incisors.

Results: Of 120 screened subjects, 95 were randomized to the study. Subjects using the low abrasivity aluminum trioxide/STP dentifrice demonstrated statistically significant (p < 0.05) and increasing improvements in surface gloss over baseline at all time points, with a significant treatment effect compared to all other study dentifrices from Week 2 (p < 0.05). With respect to dental stain, the low abrasivity dentifrice group had the lowest stain score at each post-treatment time point and demonstrated statistically significantly less stain compared to all study dentifrices at Weeks 2 (p < 0.05) and 8 (p < 0.01). For tooth smoothness, at Week 8, statistically significant increases in surface smoothness were observed for most treatment groups compared to baseline (p < 0.05), except for the moderate abrasivity dentifrice.

Conclusions: This study shows the benefit of a low abrasivity dentifrice containing STP and aluminum trioxide in reducing stain build-up and increasing tooth gloss compared to a non-alumina ultra-low abrasivity STP-containing dentifrice, and moderate and high abrasivity dentifrices, over an eight-week period.
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June 2017

A Comparison of the Effect of Two Power Toothbrushes on the Gingival Health and Plaque Status of Subjects with Moderate Gingivitis.

J Clin Dent 2017 Mar;28(1 Spec No A):A29-35

Salus Research, Ft. Wayne, IN, USA.

Objectives: To compare the effect of the Philips Sonicare DiamondClean plus Premium plaque control brush head with the Oral-B 7000 plus CrossAction brush head on gingivitis and supragingival plaque reduction following a 42-day period of home use.

Methods: This was a randomized, parallel, examiner-blind, prospective clinical trial conducted on generally healthy subjects. Eligible subjects met the following eligibility criteria: age 18-65, non-smoker, routine manual toothbrush user, ≥ 50 sites of gingival bleeding per the Gingival Bleeding Index (GBI), and ≥ 1.8 plaque score per the Modified Plaque Index (MPI), assessed three to six hours following the last oral hygiene procedure. Eligible subjects were enrolled in the study and randomly assigned to use either a Philips Sonicare DiamondClean with Premium plaque control brush head power toothbrush (SPC) or an Oral-B® 7000 with CrossAction™ brush head power toothbrush (OCA), for twice daily home use over a period of 42 days. All subjects were dispensed a standard fluoride-containing dentifrice and both toothbrushes were to be used in their respective Deep Clean modes. Safety and efficacy evaluations were performed at 14 and 42 days following Baseline.

Results: Two-hundred eighty-four subjects completed this trial (142 subjects per treatment group). Least squares mean (95% CI) estimates for reduction and percent reduction of gingivitis per Modified Gingival Index (MGI) following 42 days of product use for the SPC group were 1.17 (1.10, 1.24) and 45.68% (42.95%, 48.40%); for the OCA group they were 0.69 (0.62, 0.76) and 26.83% (24.10%, 29.56%). The mean difference (95% CI) between the two treatment groups was 0.48 (0.38, 0.58) and 18.85% (14.99%, 22.70%) for reduction and percent reduction, respectively. The lower limit of the 95% CI for the difference in Overall score between the two treatment groups was greater than the predefined non-inferiority margin (i.e., -0.10 or -5%); therefore SPC was declared non-inferior to OCA. In addition, since the 95% CI for the difference did not include zero, SPC was declared superior to OCA in the reduction of gingivitis per MGI at Day 42 (p-value < 0.0001). Similarly, for MGI at Day 14 and for GBI and MPI at Day 14 and Day 42, significantly larger reductions were observed for SPC compared to OCA (p-value < 0.0001).

Conclusions: Philips Sonicare DiamondClean with Premium plaque control brush head (SPC) was statistically superior to the Oral-B 7000 with CrossAction brush head (OCA) in reducing gingival inflammation, gingival bleeding, and supragingival plaque following 14 and 42 days of home use. Both products were safe for use.
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March 2017

An Evaluation of Plaque and Gingivitis Reduction Following Home Use of Sonicare FlexCare Platinum with Premium Plaque Control Brush Head and a Manual Toothbrush.

J Clin Dent 2017 Mar;28(1 Spec No A):A7-12

Salus Research, Ft. Wayne, IN, USA.

Objectives: To assess the effect of the Philips Sonicare FlexCare Platinum with Premium plaque control brush head on gingival inflammation, bleeding, and supragingival plaque reduction following a six-week period of home use compared to a manual toothbrush.

Methods: This was a randomized, single-blind, parallel-design clinical trial. Subjects included in the study were routine manual toothbrush users who were generally healthy non-smokers, aged 18-65 years, with mild to moderate gingivitis. Subjects with advanced periodontal disease, excessive gingival recession, and heavy deposits of calculus or rampant decay were excluded from the study. Eligible participants were dispensed either Philips Sonicare FlexCare Platinum with Premium plaque control brush head (PC), or an ADA Reference manual toothbrush (MTB) for twice-daily home oral hygiene procedures for six weeks. Efficacy measures included the Lobene and Soparker Modification of Quigley and Hein Plaque Index (MPI), the Modified Gingival Index (MGI), and Gingival Bleeding Index (GBI). Safety was evaluated by oral examination and subject report. Efficacy and safety were assessed at Baseline, and at two and six weeks following product home use.

Results: Of 154 subjects randomized, 143 subjects completed the study. For the primary endpoint, MGI at Week 2, statistically significantly larger reductions in MGI were observed for PC versus MTB, p < 0.0001. The adjusted mean reduction and standard error estimates (SE) for MGI, expressed as percent reduction versus Baseline to Week 2, were 41.73% (2.00%) for PC and 7.38% (2.02%) for MTB. Statistically significant differences were also observed for MPI and GBI at Week 2, and for all metrics at Week 6.

Conclusions: Philips Sonicare FlexCare Platinum with Premium plaque control brush head statistically significantly reduces gingival inflammation, gingival bleeding, and plaque following two and six weeks of home use, compared to manual tooth brushing alone.
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March 2017

The Effect of Use of a Sonic Power Toothbrush and a Manual Toothbrush Control on Plaque and Gingivitis.

J Clin Dent 2017 Mar;28(1 Spec No A):A1-6

Salus Research, Ft. Wayne, IN, USA.

Objectives: To compare the ability of the Philips Sonicare DiamondClean power toothbrush and the ADA Reference manual toothbrush to reduce plaque and gingival inflammation by routine manual toothbrush users.

Methods: This was a randomized, single-blind, parallel-design study. Eligible subjects were generally healthy non-smokers who exhibited mild to moderate gingivitis upon study entry. Enrolled subjects were randomly allocated to commence twice-daily home use of either a Philips Sonicare DiamondClean (DiamondClean) power toothbrush or an ADA reference manual toothbrush (MTB) for a period of four weeks. Clinical safety and efficacy were assessed after a two- and four-week period of home use. Statistical analysis was performed for the modified intent to treat (mITT) population using a mixed model with the Baseline score as a covariate.

Results: A total of 182 volunteers were screened, 144 (72 per treatment) were randomized, and 142 subjects completed this study. Following four weeks of use, the Least Square (LS) Mean SE) percent reduction in surface plaque was 34.9% (1.8) for DiamondClean and 8.0% (1.7) for MTB, (p < 0.0001). At the same four-week time point, the LS Mean (SE) percent reduction in gingival inflammation for DiamondClean was 25.5% (1.9) and 19.1% (1.9) for MTB (p = 0.0213). For gingival bleeding, the LS Mean (SE) percent reduction in sites with gingival bleeding for DiamondClean was 57.4% (3.06) and 31.4% (3.04) for MTB (p < 0.0001).

Conclusions: The Philips Sonicare DiamondClean power toothbrush was statistically significantly more effective than a manual toothbrush in reducing supragingival plaque, gingival inflammation, and gingival bleeding following a four-week period of home use. Both products were safe for home use.
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March 2017

A Randomized Clinical Study to Evaluate the Effect of Two Experimental Toothpastes on Tooth Enamel Gloss and Smoothness.

J Clin Dent 2016 Mar;27(1):7-12

GSK Consumer Healthcare, Weybridge, Surrey, UK.

Objectives: The study compared the effects on examiner-assessed tooth gloss and smoothness of two experimental toothpastes (1% or 2% alumina abrasive) with a reference, silica-based toothpaste used twice daily for one, four, and eight weeks. The study also monitored the safety of the products.

Methods: This was a randomized, examiner-blind study, stratified by gloss score and age, three-treatment, parallel-group using healthy adult volunteers. Following a two-week washout period where subjects brushed with a conventional silica-abrasive toothpaste, 169 subjects began the trial period after receiving a dental scaling and polishing using the washout toothpaste. Subjects brushed for two minutes, twice daily, with their assigned toothpaste. The experimental toothpastes contained 927 ppm fluoride as NaF with either 1% or 2% alumina as the sole abrasive. The reference toothpaste contained 927 ppm fluoride as NaF in a conventional amorphous silica abrasive base. Enamel polish (i.e., gloss) was assessed visually by comparing the facial surfaces of the maxillary incisors with a set of standards. Tooth smoothness was assessed by lightly dragging a dental explorer over the surface.

Results: Subjects using the 2% alumina toothpaste had significantly higher gloss compared to the reference toothpaste at Weeks 1 and 4, but the difference was of borderline significance at Week 8 (one-covariate analysis: p = 0.0529; two-covariate analysis: p = 0.0494). Subjects using the 1% alumina toothpaste had significantly higher gloss improvement scores than the reference toothpaste at Weeks 4 and 8, but not at Week 1. All three treatment groups' gloss scores improved during the study. Regarding tooth smoothness, the effects of the experimental toothpastes followed a broadly similar profile to the effects on tooth gloss. After four weeks' use, both experimental toothpastes were superior to the reference. After eight weeks' use, however, only the 2% alumina toothpaste approached significant superiority versus the reference (p = 0.0639).

Conclusions: The 1% and 2% alumina toothpastes improved tooth gloss compared to a standard silica toothpaste when used twice daily for two minutes over an eight-week study period. Furthermore, there was evidence of a corresponding increase in tooth smoothness.
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March 2016

Subjective Assessment of Enamelon® Preventive Treatment Gel in a Self-Reported Dry-Mouth Population.

Compend Contin Educ Dent 2016 Sep;37(8):e5-8

Director of Clinical Affairs, Premier Dental Products Co., Plymouth Meeting, Pennsylvania.

Background: The efficacy of stannous fluoride toothpastes is well established for reducing caries, plaque, and gingivitis and relieving the discomfort of dentin hypersensitivity. Management of dry mouth may include relief remedies in addition to usual oral hygiene methods to maintain oral health and improve quality of life. This 6-week, single-blind, randomized, two-period crossover clinical study was designed to evaluate the oral tolerance and potential of Enamelon® Preventive Treatment Gel (EPTG), with 0.4% stannous fluoride, to relieve subject-perceived dry-mouth symptoms in a self-reported dry-mouth population, after 14 days of use, compared to a marketed over-the-counter (OTC) artificial saliva gel product (Biotene® Oral Balance Gel [BOBG]).

Methods: Following a 7-day washout period, 52 qualified subjects with self-reported dry-mouth symptoms received EPTG or BOBG for once-daily use for 14 days. All subjects brushed each morning and evening with a standard fluoride toothpaste (Sensodyne® ProNamel). Each evening and following brushing with the Sensodyne ProNamel, subjects used their assigned gel product (EPTG or BOBG) as directed. On Days 1, 8, and 15, subjects received an oral examination and assessed relief of dry-mouth symptoms using a product-performance questionnaire (PPQ). Procedures were repeated with the alternate product for another 14-day period, following a 7-day washout. Data for each efficacy endpoint were analyzed using crossover ANOVA model.

Results: No treatment-related adverse events were reported in this study, and both products were well tolerated by the subjects. Compared to pre-study ratings of usual dry-mouth remedies, both BOBG and EPTG significantly reduced dry-mouth symptoms following 14 days of use. BOBG was statistically significantly better than EPTG in relieving many of the principal dry-mouth symptoms such as providing immediate relief, having an immediate moisturizing and immediate lubricating effect, feeling comfortable in the mouth, soothing the mouth, effectively lubricating the mouth, and protecting the mouth from drying out (P < .05). Compared with subjects' ratings of their usual dry-mouth remedies, EPTG also provided relief of several dry-mouth symptoms at both Days 8 and 15 (P < .05).

Conclusion: Based on subjective measures of dry mouth and compared with pre-study ratings of usual remedies, subjects perceived that EPTG helped to manage symptoms such as relieving the discomfort of dry mouth, immediately moisturizing and lubricating, effectively lubricating, protecting from drying out, and providing long-lasting moisturization and long-lasting lubrication, and was not irritating to dry-mouth tissues. BOBG, the positive control, was significantly better than EPTG in relieving dry-mouth symptoms over a 2-week period and was not irritating.

Practical Implications: Patients with dry-mouth symptoms may benefit from daily use of a non-irritating, OTC fluoride preventive treatment gel product to relieve symptoms while also reducing the risks of developing dental caries, demineralization, dentin hypersensitivity, and gingivitis.
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September 2016

A Randomized Clinical Study Investigating the Stain-Removal Potential of Two Experimental Dentifrices.

J Clin Dent 2015 ;26(4):96-103

Objective: To evaluate the ability of two experimental desensitizing dentifrices, both containing a chemical cleaning agent, one with ultra-low abrasivity and one with low abrasivity, a standard fluoride dentifrice, and a daily-use whitening dentifrice to remove extrinsic tooth stain.

Methods: This was a single-center, examiner-blind, randomized, controlled, four-treatment, parallel-group study in healthy adults. Extrinsic stain was evaluated using the Macpherson modification of the Lobene Stain Index (MLSI). At baseline, eligible subjects with a total MLSI (area x intensity [A x I]) score of 15 for the facial surfaces of the 12 anterior teeth were stratified (based on total MLSI [A x I] score [< 45 = low; ≥ 45 = high] and smoking status) and randomized to treatment with one of four dentifrices: an experimental ultra-low abrasivity desensitizing dentifrice (relative dentin abrasion [RDA] -12); an experimental low abrasivity desensitizing dentifrice (RDA -40); a standard fluoride dentifrice with moderate abrasivity (RDA -80); and a whitening dentifrice with higher abrasivity (RDA -142). Both desensitizing dentifrices contained 5% potassium nitrate and 5% sodium tripolyphosphate (a chemical cleaning agent). Treatment effects were evaluated after four and eight weeks of twice-daily brushing.

Results: In total, 142 subjects were randomized and 133 subjects completed the study. All study dentifrices demonstrated statistically significant reductions in extrinsic tooth stain from baseline after four and eight weeks of twice-daily use (p < 0.01). There were no statistically significant between-treatment differences for the primary variable (mean MLSI [A x I] score across all assessed sites) at four or eight weeks, and no notable trends were observed.

Conclusion: All study dentifrices reduced extrinsic tooth stain. The experimental ultra-low and low abrasivity desensitizing dentifrices containing 5% sodium tripolyphosphate performed similarly to both a moderate abrasivity standard fluoride dentifrice and a higher abrasivity whitening dentifrice.
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February 2016

Confirmation of efficacy in providing relief from the pain of dentin hypersensitivity of an anhydrous dentifrice containing 0.454% with or without stannous fluoride in an 8-week randomized clinical trial.

Am J Dent 2015 Aug;28(4):190-6

Purpose: To compare the efficacy of an anhydrous dentifrice containing 0.454% w/w stannous fluoride and a negative control dentifrice containing 1,000 ppm fluoride, as sodium monofluorophosphate, at reducing dentin hypersensitivity over 8 weeks with twice-daily brushing.

Methods: This was a randomized, examiner-blind, parallel, two treatment group, stratified (by maximum baseline Schiff sensitivity score), 8-week clinical study carried out at a single site in 119 healthy subjects with at least two sensitive teeth, who met all study criteria at the screening and baseline visits. Clinical assessments of sensitivity to evaporative (air) [with Schiff sensitivity score and visual analogue scale (VAS)] and tactile (Yeaple probe) stimuli were employed to compare the efficacy of the test dentifrice containing 0.454% w/w stannous fluoride to the negative control dentifrice at reducing sensitivity after 4 and 8 weeks treatment.

Results: Of the 119 subjects randomized to study treatment, 113 completed the study. At 4 and 8 weeks, between treatment analyses found the test dentifrice to be significantly better than the negative control dentifrice in relieving dentin hypersensitivity for all measures (Schiff: P < 0.0001 at 4 and 8 weeks; VAS score: P = 0.0003 at 4 weeks, P < 0.0001 at 8 weeks; tactile threshold: P = 0.0138 at 4 weeks, P < 0.0001 at 8 weeks).
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August 2015

A randomized, crossover trial to evaluate the effect of two mouthrinses on plaque regrowth in the absence of brushing.

Int J Periodontics Restorative Dent 2015 May-Jun;35(3):387-93

This study assessed the effects on plaque in the absence of brushing of two twice-daily mouthrinses, one with an enzymatic-based formulation (Biotène) and one with an antimicrobial chlorhexidine-based formulation (Peridex), and sterile water. Plaque levels were assessed in 23 participants using a 4-day, nonbrushing plaque regrowth model after twice-daily rinsing with sterile water (negative control), the enzyme-based mouthrinse, or the chlorhexidine-based mouthrinse (positive control). Peridex showed significantly greater prevention of plaque regrowth when compared with water and the enzyme-based Biotène mouthrinse. After 4 days, the enzyme-based mouthrinse was associated with a small but nonsignificant reduction in plaque regrowth compared with water. This study confirmed that Peridex is effective at prevention of plaque regrowth. Twice-daily rinsing with a Biotène formula that contained enzymes showed a small but nonsignificant trend toward prevention of plaque regrowth versus rinsing with water.
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http://dx.doi.org/10.11607/prd.2266DOI Listing
January 2017

Plaque reduction efficacy of an oscillating-rotating power brush with a novel brush head utilizing angled bristle tufts.

Compend Contin Educ Dent 2014 Oct;35(9):702-6

Director, Salus Research, Inc., Fort Wayne, Indiana.

Purpose: To evaluate an oscillating-rotating power brush with a novel brush head utilizing angled bristle tufts versus a manual brush for plaque removal.

Methods: This was a single-center, randomized, open-label, examiner-blind, two-treatment, parallel-group study. Subjects brushed with their assigned toothbrush and a marketed dentifrice twice daily at home for 6 weeks. Plaque measurements were evaluated at baseline and week 6 using the Turesky Modified Quigley-Hein Plaque Index (TQHPI). Data was analyzed using the analysis of covariance (ANCOVA) with baseline as the covariate.

Results: Ninety-four subjects completed the study, with 46 in the manual group and 48 in the power group. The oscillating-rotating brush with the novel brush head demonstrated statistically significantly greater reductions in whole mouth and interproximal plaque measures compared to the manual toothbrush. The benefit for the oscillating-rotating brush over the manual control brush was 164.5% for whole mouth plaque and 167.4% for interproximal plaque (P < 0.001) measured 12 hours after brushing. Both brushes produced statistically significant reductions in plaque measures relative to baseline (P < 0.001 for both measures). There were no adverse events reported or observed for either brush.

Conclusions: The oscillating-rotating brush with the novel brush head produced reductions in whole mouth and interproximal plaque more than twice that of the manual toothbrush.
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October 2014

Comparative plaque removal efficacy of two new powered toothbrushes and a manual toothbrush.

J Clin Dent 2014 ;25(2):1-5

Objective: The purpose of this study was to determine the plaque-reducing effectiveness of two new powered toothbrushes and compare them to a manual toothbrush control.

Methods: This examiner-blind, randomized study used a crossover design. Sixty-five qualifying male and female subjects were randomly assigned one of the two test powered brushes (Spinbrush Truly Radiant Deep Clean [TRDC] or Spinbrush Truly Radiant Extra Whitening [TREW], Church & Dwight Co., Inc., Princeton, NJ, USA) or an ADA standard manual toothbrush (MT; American Dental Association, Chicago, IL, USA) according to one of three computer-generated sequences. Following instruction in the use of their assigned toothbrush, subjects brushed at home with a standard fluoride toothpaste twice daily for two minutes during a one-week familiarization period. At the end of this period, the subjects returned to the study site after refraining from oral hygiene for 12-16 hours, and from eating, drinking, and smoking for four hours. Plaque was scored using the Rustogi Modification of the Navy Plaque Index. Subjects brushed under supervision with their assigned toothbrush for two minutes, and plaque was rescored. They were then given one of the alternate toothbrushes according to their assigned sequence, and the familiarization routine and evaluation processes were repeated until each of the subjects used each of the three brushes.

Results: Within-group analyses showed that all three toothbrushes produced statistically significant reductions from the pre-brushing baseline in whole mouth and regional plaque scores (p < 0.001), with respective whole mouth reductions of 17.9%, 42.3%, and 38.1% for MT, TRDC, and TREW. Between-group analyses showed that TRDC and TREW were each significantly more effective (p < 0.001) than MT, as each showed at least twice as much of a reduction in whole mouth scores. Both of the powered brushes also produced statistically significantly greater reductions than the manual brush at each of the twelve subsets of sites examined, with the greatest differences at interpoximal sites and sites presenting access difficulty, such as those in the lingual posterior region. Additionally, TRDC produced a statistically significant 11.5% greater reduction than TREW (p = 0.001) in whole mouth plaque scores, and statistically significantly greater reductions in two of the subsets evaluated.

Conclusion: Both of the powered brushes tested proved to be safe and significantly more effective than the standard manual control brush in reducing plaque. While the finding that the TRDC was significantly more effective than the TREW in reducing whole mouth plaque and plaque in two subsets demonstrates that small differences in toothbrush design may impact performance, longer-term studies would be needed to assess the extent to which this translates to meaningful clinical outcomes.
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September 2014

Digital plaque imaging evaluation of a stabilized stannous fluoride dentifrice compared with a triclosan/copolymer dentifrice.

Am J Dent 2013 Dec;26(6):303-6

Purpose: To compare the relative plaque control efficacy of a marketed 0.454% stabilized stannous fluoride (SnF2) dentifrice relative to a triclosan/copolymer dentifrice using digital plaque imaging analysis (DPIA).

Methods: This was a randomized, two-treatment, double-blind, parallel group design study that compared SnF2 and triclosan/copolymer dentifrices over a period of 3 weeks. DPIA was used to capture a digital image of the maxillary and mandibular anterior facial surfaces of 12 teeth and to calculate plaque area coverage. Overnight DPIA images were taken at a baseline visit after which subjects were randomly assigned to one of the two treatment groups and were required to brush with their assigned dentifrice according to each manufacturer's instructions. Subjects had DPIA assessments on two separate days at the end of Week 3.

Results: 96 subjects were randomized to treatment. Plaque area data for 47 subjects per treatment group were compared at Week 3 using ANCOVA. The SnF2 group demonstrated a statistically significant reduction in overnight plaque at Week 3 compared to baseline (P= 0.002). The reduction for the triclosan group at Week 3 compared to baseline was not statistically significant (P= 0.24). At Week 3, the SnF2 group demonstrated a 17% lower adjusted mean for overnight plaque relative to the triclosan group with a mean difference that was statistically significant (P< 0.05). The Week 3 adjusted mean change from baseline in overnight plaque for the SnF2 group was 3 times greater versus that of the triclosan group (P< 0.05).
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December 2013

Crossover clinical investigation of a whitening chewing gum for inhibiting dental stain formation in conjunction with tooth brushing.

J Clin Dent 2014 ;25(3):37-42

Objective: The purpose of this clinical investigation was to evaluate the effectiveness of a marketed whitening chewing gum compared to a no-gum control in preventing the formation of extrinsic stains on the teeth of stain-forming subjects when chewed over a 12-week period of regular unsupervised use in conjunction with daily tooth brushing.

Methods: This was a single-center, examiner-blind, randomized, 12-week crossover clinical trial. Stain-forming (after smoking or drinking coffee or tea) adults, starting with a stain-free baseline, either chewed the test gum (Orbit White) unsupervised four times per day, 15 minutes/chew, or used no gum along with daily brushing with a commercially available toothbrush and dentifrice for 12 weeks. At the crossover, all procedures were repeated with subjects assigned the opposite treatment. Extrinsic stain was measured at six and 12 weeks by both the Lobene Stain Index (LSI) and the Modified Lobene Stain Index (MLSI) using separate experienced examiners.

Results: After 12 weeks, LSI stain scores showed a significant 25% reduction (p = 0.0008) in new stain formation for subjects using the test chewing gum along with tooth brushing versus tooth brushing alone (no-gum control). The corresponding MLSI stain scores demonstrated a 36% reduction (p < 0.0001) in the formation of extrinsic stain on the teeth.

Conclusion: The overall findings of this clinical study demonstrated that regular use of Orbit White chewing gum, soon after smoking or drinking coffee or tea, will supplement daily tooth brushing in preventing unsightly stains from forming on the anterior teeth compared to brushing alone.
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July 2015