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.

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.

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.

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.

Evaluation of the Addition of a Water Flosser to Manual Brushing on Gingival Health.

OBJECTIVES: The purpose of this clinical trial was to compare the use of a manual toothbrush plus water flosser to a manual toothbrush alone on clinical signs of inflammation. METHODS: Seventy-two subjects were randomized into two groups and completed this four-week, single-blind, parallel, clinical trial. Group 1 used a Waterpik®Water Flosser (WF) once daily and brushed with a manual toothbrush twice a day. Group 2 brushed twice a day with a manual toothbrush only (MT). Subjects in group 1 were provided written and verbal instructions for the water flosser and all participants used the toothpaste and manual brush provided, brushing as they normally do. Data were evaluated at baseline (BSL), two weeks (W2), and four weeks (W4) for bleeding on probing (BOP), Modified Gingival Index (MGI), and Rustogi Modification of the Navy Plaque Index (RMNPI). RESULTS: Both groups showed a significant reduction from BSL for BOP, MGI, and RMNPI at W2 and W4, except for MT W2 facial proximal MGI (p = 0.153) and marginal RMNPI (p = 0.324). The WF was significantly more effective than the MT for reducing BOP, MGI, and RMNPI at W2 and W4 for all areas measured. The WF was 3.13 times as effective for reducing BOP, 2.69 times for MGI, and 2.44 times for RMNPI at W4 (p < 0.001) for whole mouth scores. CONCLUSIONS: The addition of the Waterpik®Water Flosser to manual tooth brushing is significantly more effective for improving gingival health than manual tooth brushing alone.

An exploratory clinical trial to evaluate the efficacy of an experimental dentifrice formulation in the relief of dentine hypersensitivity.

OBJECTIVES: This study aimed to investigate whether addition of an octadecene/maleic anhydride copolymer (O/MA) to a potassium nitrate (KNO3) dentifrice could facilitate delivery of potassium to dentine and enhance its efficacy in dentine hypersensitivity relief. METHODS: This was a randomised, examiner-blind, controlled, parallel group study in 139 healthy subjects with at ≥2 sensitive teeth. Assessment of dentine hypersensitivity to tactile (Yeaple probe) and evaporative (air) stimuli (Schiff Sensitivity Scale, visual analogue scale [VAS]) was carried out at baseline and after 1, 2, 4 and 8 weeks twice daily treatment with an experimental 5% KNO3/3% O/MA dentifrice, a comparator 5% KNO3 dentifrice (active comparator), a 0% KNO3/3% O/MA dentifrice (placebo) and a regular fluoride dentifrice (negative control). This study was not powered to detect statistically significant differences between treatments. RESULTS: Across the treatment period an improvement in sensitivity to evaporative air stimulus was observed for all products and to a tactile stimulus for the potassium-containing treatments, with the greatest reductions for the experimental dentifrice (5% KNO3/3% O/MA). Reductions in sensitivity observed for the potassium-containing dentifrices compared to the placebo and negative control dentifrices were statistically significantly for Schiff sensitivity score and tactile threshold at all time-points and for VAS at Weeks 4 and 8. Trends in the study data also favoured the experimental dentifrice, compared to the active comparator dentifrice, for all clinical measures. Study treatments were generally well tolerated. CONCLUSION: This study provides initial clinical evidence to suggest that addition of a polymer excipient may enhance the anti-sensitivity efficacy of potassium-containing dentifrices. CLINICAL SIGNIFICANCE: Daily use potassium-containing dentifrices are established as efficacious for the relief of dentine hypersensitivity. Inclusion of a polymer excipient in such formulations may facilitate delivery of potassium to the dentine surface and so enhance clinical efficacy. Further clinical studies are required to confirm this hypothesis.

Comparative Antiplaque Effect of Two Antimicrobial Dentifrices: Laboratory and Clinical Evaluations.

OBJECTIVES: To compare the effect of a stannous fluoride dentifrice versus a triclosan-containing dentifrice on the reduction of plaque using in vitro and clinical models. METHODS: Both investigations evaluated a novel 0.454% stabilized stannous fluoride dentifrice (Crest® Pro-Health™ smooth formula) versus a sodium fluoride/triclosan positive control dentifrice (Colgate® Total®). The in vitro evaluation utilized the Plaque Glycolysis and Regrowth Model (PGRM), wherein the metabolic effects (acid production/glycolysis inhibition) of the dentifrices were assessed on plaque biofilms grown on glass rods after three days growth and a single dentifrice treatment. Treatments were evaluated via analysis of variance, Student's t-test. The clinical trial was a four-week, single-center, randomized and controlled, double-blind, parallel group study, where 120 adults were randomized to one of the two dentifrices for use at home according to manufacturer's instructions. Plaque was evaluated at baseline and Week 4 with the Rustogi Modified Navy Plaque Index (RMNPI). Statistical analyses were via analysis of covariance. RESULTS: In vitro PGRM: The stannous fluoride dentifrice provided 43.3% glycolysis inhibition compared to 27.5% for the triclosan control, and the pH decrease associated with acid production was significantly less for stannous fluoride (0.87) versus triclosan (1.11); p < 0.05. Clinical trial: One hundred eighteen (118) subjects completed the study with fully evaluable data. Both dentifrice groups demonstrated statistically significant (p < 0.0001) reductions in plaque at Week 4 compared with baseline, with the stannous fluoride dentifrice producing a significantly lower adjusted mean Week 4 plaque score (p < 0.0001) versus the triclosan positive control for whole mouth plaque (23.1% lower) and interproximal plaque (43.5% lower). Both dentifrices were well-tolerated. CONCLUSIONS: The stabilized stannous fluoride dentifrice provided statistically significant reductions in plaque glycolysis in vitro and plaque growth in vivo compared to the triclosan dentifrice. Results for both studies were consistent.

Assessment of the Effects of a Novel Stabilized Stannous Fluoride Dentifrice on Gingivitis in a Two-Month Positive-Controlled Clinical Study.

OBJECTIVES: The aim of this study was to compare the antibleeding/antigingivitis effectiveness of a newly formulated 0.454% stabilized stannous fluoride dentifrice and a marketed positive control triclosan-containing dentifrice in adults with mild-to-moderate gingivitis. METHODS: This single-center, two-month, randomized and controlled, double-blind, parallel group clinical trial involved adults with preexisting mild-to-moderate gingivitis. Baseline bleeding and gingivitis levels were assessed with the Gingival Bleeding Index (GBI) and Lobene Modified Gingival Index (MGI). Subjects were randomly assigned to either a new smooth formula 0.454% stabilized stannous fluoride test dentifrice (Crest® Pro-Health™) or a commercially available positive control 0.30% triclosan dentifrice (Colgate® Total®). Subjects brushed with their assigned dentifrice at home according to the manufacturer's instructions. At Month 2, subjects were re-evaluated for bleeding and gingivitis as at Baseline, with MGI and GBI evaluations. RESULTS: Of the 200 subjects randomized to treatment, 197 completed the study and had fully evaluable data. At Month 2, both the stannous fluoride and triclosan control dentifrices produced statistically significant reductions (p < 0.0001) in the mean number of bleeding sites, MGI, and GBI compared to Baseline. Use of this 0.454% stannous fluoride dentifrice resulted in 22% fewer bleeding sites versus the positive control triclosan dentifrice (p < 0.0001). Similarly, after two months of brushing, the stannous fluoride dentifrice group showed statistically significant lower mean MGI and GBI scores than subjects using the triclosan positive control dentifrice (p < 0.0001). Both dentifrices were well-tolerated. CONCLUSIONS: Subjects brushing with a newly formulated stannous fluoride dentifrice had statistically significantly fewer bleeding sites and less gingivitis than those using a positive control triclosan dentifrice after two months.