Efficacy of an experimental toothpaste containing sodium bicarbonate, sodium hyaluronate and sodium fluoride on gingivitis.

BACKGROUND: Gingivitis is driven by plaque accumulation and, if left untreated, can progress to irreversible periodontitis. For many, the mechanical action of toothbrushing does not achieve adequate plaque control. The aim of this study was to investigate whether twice-daily use of a toothpaste containing 0.2% high molecular weight (HMW) sodium hyaluronate with 67% sodium bicarbonate and 0.221% sodium fluoride (experimental toothpaste) could improve gingival health compared with a regular fluoride toothpaste (negative control). The study also assessed whether the experimental toothpaste could provide additive gingival health benefit over a toothpaste containing only 67% sodium bicarbonate and 0.221% sodium fluoride (positive control). METHODS: This was a single-center, examiner-blinded, randomized, clinical study in healthy adults with mild-to-moderate gingivitis. At baseline, after abstaining from toothbrushing for 12 h, prospective participants underwent oral soft tissue (OST) and oral hard tissue examination followed by assessments for gingival inflammation (Modified Gingival Index [MGI]), gingival bleeding (Bleeding Index [BI]), and supra-gingival plaque (Turesky Plaque Index [TPI]). Eligible participants were stratified by gender and baseline number of bleeding sites (low: <45; high: ≥45 bleeding sites). Following randomization, participants underwent prophylactic dental treatment. Participants received a full OST examination, MGI, BI and TPI assessments after 3 days, 1, 2 and 6 weeks of product use. RESULTS: In total, 110 participants were screened for study entry and all were randomized to receive one of three toothpastes (experimental: sodium hyaluronate, sodium bicarbonate, sodium fluoride; positive control: sodium bicarbonate, sodium fluoride; negative control: regular fluoride toothpaste). For all measures, significant improvements were observed in participants receiving either sodium bicarbonate-containing toothpaste (experimental or positive control) compared with the regular fluoride toothpaste (negative control) at week 6. No significant difference was observed in any assessment or visit comparing the experimental toothpaste with the positive control. CONCLUSIONS: Both the experimental and the positive control toothpastes demonstrated clinically relevant improvements in gingival health compared with a regular fluoride toothpaste (negative control). However, no additional gingival health improvement was observed for the experimental toothpaste compared with the positive control, therefore, no additional gingival health benefit can be attributed to the inclusion of sodium hyaluronate in this formulation. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04737538 (04/02/2021).

Efficacy of water flossing on clinical parameters of inflammation and plaque: A four-week randomized controlled trial.

Purpose The primary prevention of periodontitis is controlling gingivitis daily. The study objective was to compare the efficacy of a pulsating water flosser to a pulsating water flosser infused with air microbubbles on clinical signs of inflammation and plaque.Methods One hundred and five participants were enrolled in this single-blind, single-center, parallel, four-week, IRB/IEC-approved clinical trial. Participants were randomly assigned to one of three groups: water flosser (WF) plus manual toothbrush, water flosser infused with microbubbles of air (MBWF) plus manual toothbrush, or dental floss (DF) plus manual toothbrush. Bleeding on probing (BOP), Modified Gingival Index (MGI), and Rustogi Modification Navy Plaque Index (RMNPI) scores were recorded at baseline, 2-weeks, and 4-weeks.Results All participants completed the study (n=105). All groups showed a statistically significant reduction for BOP, MGI, and RMNPI at 4-weeks (p<0.05, except DF marginal RMNPI). The WF group showed a statistically significant greater reduction in whole mouth BOP (0.41) compared to MBWF (0.32) and DF (0.19). This was also true for MGI (0.37, 0.30, and 0.20, respectively) and RMNPI (0.13, 0.11, and 0.06, respectively) (p<0.05 for all comparisons). No adverse events were reported.Conclusion This study demonstrates that a manual toothbrush and water flosser, with or without microbubbles, is an effective oral care regimen for controlling gingivitis over four weeks.

Efficacy of water flossing on clinical parameters of inflammation and plaque: A 4-week randomized controlled trial.

BACKGROUND: The primary prevention of periodontitis is controlling gingivitis daily. The study objective was to compare the efficacy of a pulsating water flosser to a pulsating water flosser infused with air microbubbles on clinical signs of inflammation and plaque. METHODS: One hundred and five participants were enrolled in this single-blind, single-centre, parallel, 4-week, IRB/IEC-approved clinical trial. Participants were randomly assigned to one of three groups: water flosser (WF) plus manual toothbrush, water flosser infused with microbubbles of air (MBWF) plus manual toothbrush, or dental floss (DF) plus manual toothbrush. Bleeding on probing (BOP), Modified Gingival Index (MGI) and Rustogi Modification Navy Plaque Index (RMNPI) scores were recorded at baseline, 2 and 4 weeks. RESULTS: All participants completed the study (n = 105). All groups showed a statistically significant reduction for BOP, MGI and RMNPI at 4 weeks (p < 0.05, except DF marginal RMNPI). The WF group showed a statistically significant greater reduction in whole mouth BOP (0.41) compared to MBWF (0.32) and DF (0.19). This was also true for MGI (0.37, 0.30 and 0.20, respectively) and RMNPI (0.13, 0.11 and 0.06, respectively; p < 0.05 for all comparisons). No adverse events were reported. CONCLUSION: This study demonstrates that a manual toothbrush and water flosser, with or without microbubbles, is an effective oral care regimen for controlling gingivitis over 4 weeks.

Effectiveness of a sonic-flosser toothbrush with different size brush heads and manual toothbrush plus dental floss on plaque, gingival bleeding and inflammation in adults with naturally occurring gingivitis: A 4-week randomized controlled trial.

OBJECTIVE: To compare the effectiveness of three oral hygiene groups: a novel sonic-flosser toothbrush with a compact brush head, a novel sonic-flosser toothbrush with a full size brush head and manual toothbrush plus dental floss on the reduction of gingival bleeding after 4 weeks. Secondarily, the groups were compared on the reduction of gingival inflammation and dental plaque. MATERIALS AND METHODS: One hundred and five (n = 105) healthy adults were enrolled in this randomized, examiner-blind, three-group, parallel clinical trial. Subjects were assigned to one of three groups: sonic-flosser toothbrush with full size brush head (SFF), sonic-flosser toothbrush with compact brush head (SFC), or manual toothbrush and string floss (MTF). Bleeding on probing (BOP), Modified Gingival Index (MGI), and Rustogi Modification of the Navy Plaque Index (RMNPI) scores were recorded at baseline, 2-weeks, and 4-weeks. RESULTS: All subjects completed the study. All three groups demonstrated a significant reduction in BOP, MGI and RMNPI from baseline to 4-weeks for all areas recorded (p < 0.001), except gingival margin plaque scores for SFF, SFC and MTF (p = 0.203, p = 0.082, p = 0.324 respectively). Both the SFF and SFC groups were statistically more effective than MTF for whole mouth BOP, MGI and RMNPI (p < 0.001) and proximal areas (p = 0.022 or less). There were no adverse events reported by the subjects or identified by the examiner during the study. CONCLUSION: The sonic-flosser toothbrush with a full size or compact brush head was statistically and clinically more effective at improving gingival health and reducing plaque than manual toothbrush and dental floss for adults with naturally occurring gingivitis over 4-weeks.

Gingival health effects with an oscillating-rotating electric toothbrush with micro-vibrations and a novel brush head designed for stain control: Results from a 12-week randomized controlled trial.

PURPOSE: To evaluate the reduction of plaque and gingivitis by an oscillating-rotating (O-R) smart-connected electric rechargeable toothbrush with micro-vibrations used with a novel brush head designed for stain control versus a manual toothbrush. METHODS: 100 adult subjects with evidence of gingivitis and plaque were enrolled in this single-center, examiner-blind, two-treatment, parallel-group, controlled trial. Subjects were randomized to either the O-R toothbrush used in whitening mode (Oral-B iO with Radiant White brush head) or the manual toothbrush (Oral-B Indicator). Subjects brushed twice daily with their assigned toothbrush and a standard sodium fluoride dentifrice. At baseline, week 1, and week 12, gingivitis was assessed with the Modified Gingival Index (MGI) and the Gingival Bleeding Index (GBI), and plaque was assessed with the Rustogi Modification of the Navy Plaque Index (RMNPI). Gingival case status was classified as " healthy" (< 10% bleeding sites) or "not healthy" (≤ 10% bleeding sites) according to the standard of the American Academy of Periodontology and the European Federation of Periodontology. RESULTS: All 100 subjects who were randomized to treatment completed the study. At baseline, the gingival case status for all subjects was classified as "not healthy". By week 12, 86% of subjects in the O-R brush group had transitioned to a " healthy" case status, in contrast to 20% of subjects in the manual toothbrush group (P< 0.001). The reduction in the adjusted mean number of bleeding sites from baseline was greater for the O-R brush group than for the manual brush group [at week 12, by 24.5 (74.6%) vs. by 7.8 (23.7%), respectively; P< 0.001]. Reductions for adjusted mean MGI and GBI scores were likewise statistically significantly greater for the O-R brush group relative to those of the manual brush group (P< 0.001). The O-R brush also provided greater relative reductions in adjusted mean whole mouth, gingival margin and approximal RMNPI scores at week 12 (P< 0.001), and plaque was similarly reduced in the lingual and buccal subregions (P< 0.001). Significant between-group plaque reductions favoring the O-R brush were observed for all regions as early as first use (P< 0.001). CLINICAL SIGNIFICANCE: The results of this 12-week study support the recommendation of the O-R toothbrush with micro-vibrations, used in whitening mode with a novel brush head designed for stain control, so patients motivated by esthetic desires can personalize their brushing experience without compromising cleaning and gingival health efficacy.

A 12-Week Randomized Controlled Trial Comparing a Novel Electric Toothbrush With an Extra Gentle Brush Head to a Manual Toothbrush for Plaque and Gingivitis Reduction.

OBJECTIVE: This study compared the gingivitis and plaque reduction efficacy of a novel smart-connected oscillating-rotating (O-R) electric toothbrush with micro-vibrations, used in Sensitive mode with an extra gentle ("sensitive") brush head, to the efficacy of a soft manual toothbrush. METHODS: This was a 12-week, examiner-blind, two-treatment, parallel-group clinical trial with 100 adult subjects (N = 100) having evidence of gingivitis and plaque at baseline. Subjects were randomly assigned to use either the O-R electric rechargeable toothbrush (Oral-B iO with Oral-B Gentle Care brush head) or the soft manual toothbrush (Oral-B Indicator). Gingivitis was assessed with the modified gingival index (MGI) and the gingival bleeding index (GBI). Plaque was assessed with the Rustogi modification of the navy plaque index (RMNPI). Patients were classified as having a "healthy" or "not healthy" gingival case status according to the criteria of the American Academy of Periodontology and the European Federation of Periodontology. Efficacy assessments and oral soft-tissue examinations were conducted before brushing at baseline, week 1, and week 12. The baseline assessment included both pre- and post-brushing plaque evaluations to evaluate single-use plaque removal efficacy. RESULTS: All 100 subjects completed the trial. Subjects had a mean age of 49.1 years; 72% were females. The O-R brush group had a significantly higher percentage of subjects who transitioned from "not healthy" to "healthy" gingival case status than did the manual brush group. Plaque reduction for the O-R brush group was also significantly greater (P ≤ .009) than for the manual brush group for whole mouth, gingival margin, and interproximal region, from day 1 (single use) through 12 weeks. Both brushes were well tolerated. CONCLUSION: The novel O-R toothbrush with micro-vibrations used in Sensitive mode with an extra gentle brush head provided significantly greater gingivitis and plaque reduction than did a manual toothbrush over 12 weeks.

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.

Anti-gingivitis and Anti-plaque Efficacy of an Oral Hygiene System: Results From a 12-Week Randomized Controlled Trial.

The objective of this study was to compare the antigingivitis and antiplaque efficacy of an oral hygiene system versus a control regimen. This was a single-center, randomized, examiner-blind, two-treatment, 12-week parallel group study in adults with evidence of gingivitis and plaque. Eligible subjects were stratified by baseline gingivitis and plaque scores, number of bleeding sites, and tobacco use and randomized to one of two treatment groups: (1) oral hygiene system (test group) involving a novel smart-connected Oral-B® iO oscillating-rotating (O-R) electric toothbrush, 0.454 percent stabilized stannous fluoride (SnF2) dentifrice, 0.07 percent cetylpyridinium chloride (CPC) rinse, and floss, or (2) control regimen involving a manual toothbrush and 0.243 percent sodium fluoride dentifrice. Gingivitis (modified gingival index, gingival bleeding index) and plaque (Rustogi modification of the navy plaque index) were assessed at Baseline, Week 1, and Week 12.

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.

A 6-month randomized controlled trial evaluating a novel smart-connected oscillating-rotating toothbrush versus a smart-connected sonic toothbrush for the reduction of plaque and gingivitis.

PURPOSE: This 6-month study compared the effects of a smart-connected oscillating-rotating (O-R) electric rechargeable toothbrush with micro-vibrations with those of a marketed smart-connected sonic rechargeable toothbrush for the reduction of gingivitis and plaque. METHODS: In this single-center, examiner-blind, two-treatment, open-label, parallel-group, randomized study, 110 adult subjects with evidence of gingivitis and plaque were randomized to use either the O-R brush (Oral-B iO) or the sonic brush (Philips Sonicare DiamondClean). Both groups were instructed to brush twice daily with a standard sodium fluoride dentifrice. Gingivitis and plaque were assessed at baseline, week 1, and week 24 using the Modified Gingival Index (MGI), Gingival Bleeding Index (GBI), and the Rustogi Modification of the Navy Plaque Index (RMNPI). Designation of gingivitis case status as "healthy" or " not healthy" was made according to the World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. RESULTS: A significantly greater percentage of subjects in the O-R brush group versus the sonic brush group transitioned from " not healthy" to " healthy" gingivitis case status at week 24 (96.4% vs. 81.8%; P= 0.029). The O-R toothbrush produced a significantly greater reduction in adjusted mean MGI score, adjusted mean GBI score, and adjusted mean number of bleeding sites than did the sonic brush (week 24, by 32.6% for MGI score, by 23.7% for GBI score, and by 26.1% for number of bleeding sites, P< 0.001). After a single use on day 1, plaque removal was statistically significantly greater for the O-R brush compared to the sonic brush (P< 0.001); by week 24, the O-R brush demonstrated greater reductions in whole mouth plaque (24.6%), gingival margin plaque (61.9%) and approximal region plaque 25.8% (P≤ 0.007 for all) compared to the sonic brush. CLINICAL SIGNIFICANCE: This 6-month study provides evidence supporting use of a smart-connected O-R electric toothbrush with micro-vibrations for plaque removal and gingivitis reductions, resulting in transitions to a healthy gingival state.

Comparative plaque removal efficacy of a new children's powered toothbrush and a manual toothbrush: Randomized, single use clinical study.

PURPOSE: To compare the plaque removal efficacy of a new children's powered toothbrush to a children's manual toothbrush. METHODS: 55 subjects aged 5-8 years old, who met entry criteria, participated in this single-center, two-cell, examiner-blind, randomized, crossover, single use clinical study. Subjects brushed at home with their first assigned toothbrush and fluoride toothpaste, under supervision of a parent or legal guardian, at least once daily for 2 minutes during a 1-week acclimation period. After refraining from oral hygiene for 12-16 hours, and from eating and drinking for 4 hours, subjects returned to the clinical site where they were assessed for plaque using the Rustogi Modified Navy Plaque Index (RMNPI). Subjects then brushed their teeth with their assigned toothbrush and toothpaste for 2 minutes and plaque levels were reassessed. Subjects were then given their second assigned toothbrush and the acclimation period and clinical site visit were repeated. Safety-in-use was also assessed during each clinic visit. Differences between pre-and post-brushing scores were analyzed for each toothbrush and between toothbrush groups for whole mouth plaque and 12 subset sites using baseline adjusted ANCOVA. RESULTS: Both toothbrushes significantly (P< 0.0001) reduced whole mouth and 12 subset site plaque scores from the pre-brushing baseline. Between treatment comparisons showed that use of the powered toothbrush resulted in statistically significant reductions in whole mouth plaque (55%, P< 0.0001) and in 12 subset site scores (40-208%) compared to the manual brush. This clinical study showed that brushing with a new children's powered toothbrush was safe and significantly more effective than brushing with a manual toothbrush in reducing whole mouth plaque scores, as well as plaque scores at a range of subset sites in the mouth. CLINICAL SIGNIFICANCE: This new powered toothbrush may enable children to safely achieve significant and meaningful improvements in oral hygiene compared to brushing with a manual toothbrush.

The effects of two baking-soda toothpastes in enhancing mechanical plaque removal and improving gingival health: A 6-month randomized clinical study.

PURPOSE: To compare the effectiveness in reducing plaque and gingivitis of two fluoride toothpastes containing baking soda (35% and 20%) with a fluoride toothpaste control. METHODS: 319 subjects, who met entry criteria, participated in this single-center, three-cell, double-blind, randomized, parallel-group clinical study. Gingival Index (MGI), Gingival Bleeding Index (GBI), and Plaque Index (PI) were assessed at baseline, and after 6 weeks, 3 and 6 months. RESULTS: All three toothpastes significantly (P< 0.0001) reduced MGI, GBI, and PI versus baseline, and the two baking soda toothpastes significantly (P< 0.0001) reduced MGI, GBI, and PI compared to the fluoride control, at all three time points. After 6 months use, the 35% and 20% baking soda toothpastes had reduced MGI, GBI and PI by 15.0%, 46.9%, and 18.3%, and 9.4%, 25.9%, and 12.4%, respectively, compared to the control. In addition, the 35% baking soda toothpaste had reduced (P≤ 0.0005) MGI, GBI, and PI by 6.2%, 28.4%, and 6.8%, respectively, compared to the 20% baking soda toothpaste. This clinical study showed that brushing with fluoride toothpastes containing baking soda at 35% and 20% reduces plaque, gingival inflammation and bleeding more effectively than regular fluoride toothpaste. Further, it showed that 35% baking soda toothpaste was more effective in reducing these parameters than 20% baking soda toothpaste. CLINICAL SIGNIFICANCE: Fluoride toothpastes containing 20% or more baking soda can provide significant and meaningful gingival health benefits when used regularly as an adjunct to tooth brushing.

Enhanced plaque removal to improve gingival health: 3-month randomized clinical study of the effects of baking soda toothpaste on plaque and gingivitis.

PURPOSE: To compare the effectiveness in reducing plaque and gingivitis of a fluoride toothpaste with 20% baking soda and a fluoride toothpaste control. METHODS: 159 subjects, who met the entry criteria, participated in this single-center, double-blind, randomized, parallel-group clinical study. Gingival Index (MGI), Gingival Bleeding Index (GBI), and Plaque Index (PI) were assessed after 4, 8, and 12 weeks use of the assigned test or control toothpaste. After 12 weeks, participants resumed 4 weeks of their customary oral hygiene after which they were re-evaluated using the same measures. RESULTS: Both toothpastes statistically significantly reduced MGI, GBI, and PI versus baseline at all-time points. Brushing with the 20% baking soda toothpaste statistically significantly reduced MGI, PI, and GBI compared to the control toothpaste at all time points. After 12 weeks, the reductions in MGI, PI, and GBI were 12.6%, 9.6%, and 44.2%, respectively. After the 4-week customary oral hygiene period, the benefits of the study period had begun to diminish, but statistically significant reductions in MGI and GBI for the test versus control were still evident. This 3-month clinical study shows that brushing with fluoride toothpaste containing 20% baking soda reduces dental plaque and concurrently reduces gingival inflammation and bleeding compared to toothpaste with fluoride alone. CLINICAL SIGNIFICANCE: Fluoride toothpaste with 20% baking soda has the potential to offer multiple oral health benefits when used as an adjunct to regular tooth brushing and, therefore, may be confidently recommended to patients.

An 8-week randomized controlled trial comparing the effect of a novel oscillating-rotating toothbrush versus a manual toothbrush on plaque and gingivitis.

PURPOSE: To compare a novel oscillating-rotating (O-R) electric rechargeable toothbrush with micro-vibrations (Oral-B iO) to a manual brush for gingivitis and plaque reduction. METHODS: Adult subjects with gingivitis and plaque were randomized to use either the O-R or the manual toothbrush with standard fluoride dentifrice twice daily. Efficacy was assessed at baseline, week 1, and week 8 using the Rustogi Modification of the Navy Plaque Index (RMNPI), Modified Gingival Index (MGI), and Gingival Bleeding Index (GBI). Gingivitis status ('healthy'/'not healthy') was also assessed, per the American Academy of Periodontology/European Federation of Periodontology criteria. RESULTS: One hundred and ten subjects were enrolled and completed the randomized controlled trial. The baseline mean number (SD) of bleeding sites for all subjects was 32.11 (16.703). At week 8, 82% of subjects using the O-R toothbrush were categorized as 'healthy' (<10% bleeding sites), versus 24% of subjects using the manual brush (P < 0.001). Subjects using the O-R toothbrush showed statistically significantly greater reductions (P < 0.001) in the number of bleeding sites, GBI scores and MGI scores versus those using a manual toothbrush as early as 1 week and throughout the 8-week study. The O-R toothbrush also provided statistically significantly greater reductions (P < 0.001) in all plaque measures, including sub-regions, versus the manual toothbrush after a single brushing and at weeks 1 and 8. CONCLUSIONS: The novel O-R electric toothbrush with micro-vibrations provided statistically significantly greater plaque and gingivitis reductions versus a manual toothbrush, with performance benefits demonstrated after a single brushing and continuing throughout the 8-week study.

Evaluation of an oscillating-rotating toothbrush with micro-vibrations versus a sonic toothbrush for the reduction of plaque and gingivitis: results from a randomized controlled trial.

PURPOSE: To compare a novel oscillating-rotating (O-R) electric rechargeable toothbrush with micro-vibrations to a marketed premium sonic toothbrush for reduction of gingivitis and plaque in an 8-week randomized controlled trial. METHODS: Adult subjects with evidence of gingivitis and plaque were randomized to use either the novel O-R brush (Oral-B iO) or the sonic brush with sodium fluoride dentifrice twice daily. Assessments at baseline and week 8 included the Rustogi Modification of the Navy Plaque Index (RMNPI), Modified Gingival Index (MGI), and Gingival Bleeding Index (GBI). Gingivitis status ('healthy'/'not healthy') was classified per the American Academy of Periodontology/European Federation of Periodontology criteria. RESULTS: Ninety subjects were randomized to treatment and completed the study. Subjects had a mean age of 49.2 years; 68 were females. At baseline, the mean number (standard deviation [SD]) of bleeding sites for all subjects was 32.8 (16.43). At week 8, the O-R brush group had a higher percentage of 'healthy' gingiva subjects than the sonic brush group (84% vs. 53% P = 0.003). In the between-group comparisons at week 8, the O-R brush group showed statistically significantly greater reductions (P < 0.001) compared to the sonic group for MGI, GBI, and number of bleeding sites. The O-R brush group also had statistically significantly greater plaque removal (P ≤ 0.011) than the sonic brush group for whole mouth plaque as well as plaque in the proximal regions and along the gingival margin. CONCLUSIONS: The novel O-R electric toothbrush with micro-vibrations provided greater plaque and gingivitis reductions than the marketed premium sonic toothbrush over 8 weeks.

Efficacy of the Use of a Water Flosser in Addition to an Electric Toothbrush on Clinical Signs of Inflammation: 4-Week Randomized Controlled Trial.

This study compared the use of an oscillating-rotating powered toothbrush and a water flosser to the use of an oscillating-rotating powered toothbrush on the reduction of clinical signs of inflammation and plaque. METHODS: Seventy adult participants (N = 70) completed this examiner-blind, two-group, parallel clinical trial. The participants were randomized into either the water flosser + oscillating-rotating powered toothbrush (WF) group or the oscillating-rotating powered toothbrush only group (OR). Inflammation was measured by bleeding on probing (BOP) and modified gingival index (MGI) at baseline, 2 weeks, and 4 weeks. Plaque was scored using Rustogi Modification of the Navy Plaque Index (RMNPI) at the same timepoints. Data was reported for whole mouth, areas (marginal and proximal), and surfaces (facial and lingual). A post-study Likert scale questionnaire was completed at the 4-week visit. RESULTS: Both groups demonstrated significant reductions in BOP, MGI, and RMNPI from baseline to 4 weeks for whole mouth (P < .001). The WF group was 37% more effective at reducing BOP, 36% for MGI, and 33% for RMNPI than the OR group at 4 weeks for whole mouth (P < .001; except RMNPI P = .003). Additionally, the WF group was significantly more effective at reducing proximal BOP (37%, P < .001), MGI (46%, P < .001), and RMNPI (52%, P = .004) compared to OR at 4 weeks. The questionnaire revealed subjects in both groups felt the device was easy to use, the instructions were clear, and their mouth felt fresh and clean. There were no adverse events reported during the study. CONCLUSION: An oral hygiene regimen consisting of the use of a water flosser in addition to an oscillating-rotating powered toothbrush significantly improved gingival health. The products used in both groups were effective and well-tolerated by the study population.

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.

A 5-week randomized clinical evaluation of a novel electric toothbrush head with regular and tapered bristles versus a manual toothbrush for reduction of gingivitis and plaque.

OBJECTIVE: To evaluate the efficacy of an oscillating-rotating (O-R) electric rechargeable toothbrush with a novel round brush head comprised of regular and tapered bristles in reducing plaque and gingivitis versus a manual toothbrush. METHODS: This was a randomized, examiner-blind, parallel group, five-week study. Participants with mild-to-moderate plaque and gingivitis received an oral examination and were evaluated for baseline plaque (Rustogi Modified Navy Index), gingivitis (Modified Gingival Index) and gingival bleeding (Gingival Bleeding Index). Qualifying participants were randomly assigned to the novel Oral-B sensitive brush head (EB60) on an Oral-B Vitality O-R handle (D12) or an ADA manual toothbrush. Participants brushed twice daily with the assigned brush and a standard fluoride dentifrice for 5 weeks before returning for an oral examination and plaque and gingivitis evaluations. RESULTS: A total of 150 participants were randomized to treatment and completed the study (mean age = 45.7 years). Both brushes demonstrated a statistically significant reduction in number of bleeding sites versus baseline (P < 0.001). At Week 5, the number of bleeding sites was reduced from baseline by 11.15 (52.2%) for the O-R brush and 5.04 (23.6%) for the manual brush. The treatment difference was statistically significant (P < 0.001). Significant reductions versus baseline (P < 0.001) were also seen for both brushes for MGI, GBI and Rustogi plaque measures (whole mouth, gingival margin and proximal), but the O-R brush produced significantly greater reductions versus the manual brush (P < 0.001). CONCLUSION: The O-R handle and round brush head with tapered and regular bristles produced greater plaque and gingivitis reductions than the manual brush.

An 8-Week Clinical Comparison of an Oscillating-Rotating Electric Rechargeable Toothbrush and a Sonic Toothbrush in the Reduction of Gingivitis and Plaque.

OBJECTIVES: To evaluate and compare the efficacy of a marketed oscillating-rotating electric rechargeable toothbrush to a marketed sonic toothbrush in the reduction of gingivitis and plaque over an 8-week period. METHODS: This was a randomized, examiner-blind, parallel group, eight-week study. Subjects with presence of mild-to-moderate plaque and gingivitis received an oral examination and were evaluated for baseline gingivitis (Modified Gingival Index; MGI), gingival bleeding (Gingival Bleeding Index; GBI), and plaque (Rustogi Modified Navy Plaque Index). Qualified subjects were randomly assigned to an entry-level oscillating-rotating electric rechargeable brush handle (Oral-B® PRO 1000, D16U) with a round brush head with angled bristles (Oral-B® CrossAction, EB50) or a premium sonic brush (Philips Sonicare® Diamond Clean Toothbrush with AdaptiveClean brush head). One hundred and fifty subjects were instructed to brush twice daily with their assigned brush and a fluoride dentifrice for eight weeks before returning for an oral examination and gingivitis and plaque evaluations. The same methods were used at baseline and Week 8 for all evaluations. RESULTS: One hundred and forty-eight subjects completed the study, 74 in each group. After eight weeks of use, both brushes reduced MGI, GBI, total number of bleeding sites, whole mouth plaque, gingival margin plaque, and proximal plaque (p < 0.001 for each). The oscillating-rotating brush provided statistically significantly greater reductions than the sonic brush for all gingivitis measures, with a 34.8%, 48.4%, and 42.6% greater reduction for MGI, GBI, and number of bleeding sites, respectively, after eight weeks of use (p < 0.001 for each). Significantly greater whole mouth (26.2%) and proximal (38.5%) plaque reductions were also demonstrated at Week 8 for the oscillating-rotating brush versus the sonic brush (p < 0.001). CONCLUSIONS: The entry-level oscillating-rotating brush performed better than the premium sonic brush in the reduction of plaque and gingivitis in this eight-week randomized and examiner-blind study.