Plaque removal by a novel prototype power toothbrush versus a manual toothbrush: A randomized, exploratory clinical study.

OBJECTIVES: This exploratory study investigated plaque removal with a prototype constant, low rotation speed Power Toothbrush (PTB) with two brushing actions: "Gumline" (head rotates in the horizontal axis) and "Interdental" (head rotates in the vertical axis). Gumline alone and "Combined" (Gumline + Interdental) modes were compared with a Reference PTB and a Reference Manual Toothbrush (MTB) after one brushing. MATERIALS AND METHODS: Thirty-nine participants were randomized to use each toothbrush once either in the sequence (A) Prototype PTB (in Gumline then Combined mode), (B) reference MTB, and (C) reference PTB or the sequence BAC. There was a minimum 3-day washout between the use of each toothbrush. Plaque removal was measured using the Rustogi Modified Navy Dental Plaque Index (RMNPI) with change from baseline investigated using an analysis of covariance model. RMNPI scores were calculated on a "whole mouth" basis and along the gingival margin and at proximal sites only. RESULTS: For the primary efficacy variable, a significant difference was found in favor of the prototype PTB in gumline mode versus the reference MTB for whole mouth plaque score (difference: -0.06; standard error: 0.014; 95% confidence interval [CI] -0.09 to -0.04; p < .0001). Similar significant differences were found in gingival margin and proximal areas (p < .0001). The prototype PTB in gumline mode removed significantly less plaque than the prototype PTB in combined mode and the reference PTB (p < .0001; whole mouth/gingival/proximal areas). The prototype PTB in combined mode removed significantly more plaque than the reference MTB (p < .0001; whole mouth/gingival/proximal areas) and the reference PTB for whole mouth (p = .0214) and gingival margin areas (p = .0010). The reference PTB also removed significantly more plaque than the reference MTB (p < .0001; whole mouth/gingival/proximal areas). All brushes were generally well-tolerated. CONCLUSION: The prototype PTB design, providing two distinct cleaning modalities, can effectively remove plaque to a significantly higher degree than an MTB and a marketed PTB, depending on mode.

Efficacy of an occluding toothpaste on dentinal hypersensitivity over 14 days.

OBJECTIVES: To evaluate a 0.454% stannous fluoride/5% sodium tripolyphosphate (STP) toothpaste's ability to provide relief from dentinal hypersensitivity (DH) applied using 'focused brushing.' MATERIALS AND METHODS: In two randomised, examiner-blind, parallel-group studies, a SnF2/STP toothpaste was applied by brushing two selected sensitive teeth before 1 min whole-mouth brushing, compared to 1 min whole-mouth brushing only, with a negative control toothpaste. DH was assessed via evaporative (air) (Schiff scale) and tactile (Yeaple probe) stimuli after 7 and 14 d of twice-daily brushing. RESULTS: In total, 141 (Study 1)/142 (Study 2) participants were randomised. In Study 1, the test treatment significantly reduced DH at 7/14 d versus baseline (7/14 d Schiff difference: -0.74 [-0.84,-0.65]/-1.39 [-1.54,-1.23]; tactile: 6.00 [4.88,7.13]/15.30 [13.34,17.26]); whereas the Control treatment did not (7/14 d Schiff difference -0.03 [-0.13,0.06]/-0.10 [-0.25,0.06]; tactile: 0.77 [-0.36,1.90]/0.77 [-1.20,2.74]). Differences between Test and Control were statistically significant (p < 0.0001 all cases). In Study 2, both treatments reduced DH compared to baseline by both measures, but there were no significant between-treatment differences. Toothpastes were generally well-tolerated. DISCUSSION AND CONCLUSIONS: Previous studies and Study 1 support SnF2/5% STP toothpaste efficacy; Study 2 results may have been influenced by placebo/Hawthorne effects. DH study design needs to, where possible, negate such effects.

Randomised clinical studies investigating immediate and short-term efficacy of an occluding toothpaste in providing dentine hypersensitivity relief.

BACKGROUND: Dentine hypersensitivity (DH) can occur after gum recession or enamel loss and may impact quality of life. Treatments include toothpastes that decrease DH by occluding dentine tubules. One effective occluding ingredient used in toothpastes is stannous fluoride (SnF2), but this can be unstable in aqueous formulation. These three studies aimed to characterise the short-term effects of an experimental, anhydrous SnF2 dentifrice on DH. METHODS: Three examiner-blind, parallel-group studies evaluated DH in participants with the condition after a single brushing and after 3d brushing with an experimental anhydrous 0.454% SnF2/polyphosphate toothpaste (Test) or a toothpaste containing 0.76% sodium monofluorophosphate (Control). Test treatment participants brushed two pre-identified sensitive teeth first, then their remaining dentition for ≥1 min ('focused brushing'). Control treatment participants brushed their whole dentition for ≥1 min. DH was measured after single brushing and after 3d twice-daily use, via evaporative (air) (Schiff Sensitivity Scale) and tactile (Yeaple probe) stimuli and analysed using an ANCOVA model. RESULTS: In all studies, after 3d treatment, the Test toothpaste/brushing regimen significantly reduced DH compared to the Control regimen by both evaporative and tactile stimuli assessment (p < 0.0001 for all). The Test regimen also significantly reduced DH from baseline at both time-points by both measures in all studies (p < 0.0001 for all). Mean Schiff sensitivity score differences (95% confidence intervals) between Test and Control regimens after 3d were: Study 1: - 0.45 (- 0.577, - 0.319); Study 2: - 0.40 (- 0.505, - 0.300); Study 3: - 1.31 (- 1.500, - 1.128). Mean tactile score differences were: Study 1: 11.30 (7.927, 14.662); Study 2: 3.57 (2.531, 4.614); Study 3: 24.54 (20.349, 28.736). After single use, in Studies 2 and 3, the Test toothpaste/brushing regimen significantly reduced DH versus Control by both measures (p < 0.001 for all); in Study 1, treatment differences were not significant. Toothpastes were generally well-tolerated. CONCLUSIONS: Taken together, these studies indicated focused brushing with an experimental anhydrous 0.454% SnF2/polyphosphate toothpaste reduces DH compared to brushing with a conventional toothpaste after single use, with greater reduction after 3d. TRIAL REGISTRATION: Registrations at ClinicalTrials.gov : Study 1: NCT02832375 (registered 26.July.2016); Study 2: NCT02731833 (registered 26.April.2016); Study 3: NCT02923895 (registered 5.October.2016).

Stain control with two modified stannous fluoride/sodium tripolyphosphate toothpastes: A randomised controlled proof of concept study.

OBJECTIVE: To compare build-up of extrinsic tooth stain following use of two novel anhydrous stannous fluoride/sodium tripolyphosphate (SnF2/STP) toothpastes with adjusted (lower) relative dentin abrasivities (RDAs) versus a marketed control and a reference toothpaste. METHODS: Following prophylaxis, 220 adults with extrinsic dental stain on anterior teeth facial surfaces were randomised to 4 weeks' twice-daily brushing with either novel 0.454% w/w SnF2 (1100ppm fluoride)/5% w/w STP toothpastes with differing levels of abrasive silica: 'Test RDA∼58'; 'Test RDA∼77', or a reference: 'Ref RDA∼80' (1000ppm fluoride from sodium monofluorophosphate) or marketed control toothpaste: 'Ref RDA∼120' [0.454% w/w SnF2 (1100ppm fluoride)/5% w/w STP]. Primary endpoint was total Macpherson modification of the Lobene Stain Index (MLSI) area×intensity (A×I) score at Week 4 for Test toothpastes versus Ref RDA∼80. Secondary endpoints were total MLSI (A×I) for all toothpastes versus Ref RDA∼120. RESULTS: After 4 weeks, mean total MLSI scores for Test RDA∼58, Test RDA∼77 and Ref RDA∼80 were all lower than Ref RDA∼120. Ranking order of performance for controlling stain build-up was: Test RDA∼77 > Test RDA∼58 > Ref RDA∼80 > Ref RDA∼120. There was no statistical difference between Test RDA∼58 and Ref RDA∼80; Test RDA∼77 was statistically lower than RDA∼80. All toothpastes were generally well-tolerated. CONCLUSION: This study showed low levels of stain build-up after 4 weeks' twice-daily use of novel, low abrasivity, anhydrous SnF2 toothpaste formulations (RDA∼58, RDA∼77), similar to marketed toothpastes (RDA∼80; RDA∼120). Lowering the RDA of appropriately formulated SnF2 toothpastes therefore may not negatively impact stain build-up potential (Clinicaltrials.gov NCT03160703). CLINICAL SIGNIFICANCE STATEMENT: This study indicates lowering RDA of an anhydrous SnF2 toothpaste does not appear to negatively impact its overall dental stain control potential. Development of appropriately formulated SnF2 toothpastes with lower abrasivity may have additional benefits for individuals with dentin hypersensitivity by managing potential dentin wear.

Efficacy of an experimental 3% potassium nitrate mouthwash in providing long-term relief from dentin hypersensitivity:An 8-week randomized controlled study (Study 1).

PURPOSE: To evaluate the efficacy of an experimental mouthwash containing 3% potassium nitrate (KNO3) in relieving dentin hypersensitivity when used as an adjunct to brushing with fluoride toothpaste compared with use of the same toothpaste alone. METHODS: This was one of three randomized, two-treatment, examiner-blind, parallel-design, single-site, 8-week studies in healthy subjects with self-reported and clinically diagnosed dentin hypersensitivity. Subjects were randomized to receive either fluoride toothpaste plus 3% KNO3 mouthwash or the same fluoride toothpaste alone, and instructed to use their allocated treatment twice daily for the next 8 weeks. Dentin hypersensitivity was evaluated at baseline and following 4 and 8 weeks of treatment through assessment of responses to evaporative (air) and tactile stimuli [measured by the Schiff Sensitivity Scale, a visual rating scale (VRS), and tactile threshold, respectively], and using the Dentin Hypersensitivity Experience Questionnaire (DHEQ; a validated quality-of-life instrument for dentin hypersensitivity). RESULTS: A total of 216 subjects were randomized and 214 completed the study. Both treatment groups demonstrated statistically significant reductions from baseline for each clinical measure of sensitivity (P≤ 0.01) at Weeks 4 and 8. Use of the 3% KNO3 mouthwash after brushing with fluoride toothpaste resulted in statistically significantly greater reductions in sensitivity to an evaporative (air) stimulus (mean Schiff score and mean VRS, P< 0.001; primary objective mean Schiff score at Week 8, P< 0.0001) and statistically significantly higher tactile threshold (P< 0.001) at Weeks 4 and 8 compared with toothpaste alone. The DHEQ responses reflected the clinical outcomes for several parameters, indicating a significant improvement in oral health-related quality of life after 8 weeks' use of the 3% KNO3 mouthwash. CLINICAL SIGNIFICANCE: The results of this study suggest that daily use of a 3% KNO3 mouthwash as an adjunct to brushing with fluoride toothpaste provides clinically relevant improvements in dentin hypersensitivity after 8 weeks' twice-daily use.

Early benefits with daily rinsing on gingival health improvements with an essential oil mouthrinse--post-hoc analysis of 5 clinical trials.

PURPOSE: The aim of this investigation through post-hoc analyses was to determine the ability to achieve gingival health in the short term with daily rinsing with an essential oil containing antimicrobial mouthrinse. METHODS: Conventional Analysis of Covariance (ANCOVA) on whole mouth mean plaque and gingivitis scores were originally conducted to demonstrate efficacy of adjunctive use of Cool Mint® LISTERINE® Antiseptic (EO) compared to negative control [brushing (B) or brushing/flossing (BF)] in each of 5 studies containing a 4 week evaluation. The Modified Gingival Index (MGI) was split into 2 categories: healthy (scores 0, 1) and unhealthy (≥2). Data, reflecting subjects that completed 4 weeks of treatment from 5 studies, were evaluated to determine the mean percent of healthy sites and mean percent of more inflamed "affected" areas (MGI≥3). RESULTS: At baseline, the mean percent healthy gingival sites ranged from 0.1 to 3.2%. At 4 weeks, up to 29.3% and 16.1% of sites were healthy for the EO group and negative control group, respectively. Three and 6 month data from 2 of the 5 studies resulted in up to 39.6% and 62% at 3 and 6 month mean percent healthy sites per subject for EO and up to 17.2% and 15.6% at 3 and 6 months, respectively, for negative control. Virtually plaque free sites (PI=0, 1) at 4 weeks ranged up to 34.3% and 8.1% for EO and control groups, respectively. CONCLUSION: Significantly more healthy gingival sites and virtually plaque free tooth surfaces can be achieved as early as 4 weeks with use of an essential oil antimicrobial mouthrinse. This finding continues through 6 months twice daily use as part of oral care practices compared to mechanical oral hygiene alone.