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.

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.

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.

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.

Comparison of Water Flosser and Interdental Brush on Reduction of Gingival Bleeding and Plaque: A Randomized Controlled Pilot Study.

OBJECTIVES: The purpose of this randomized, two-week, single blind, two-group parallel pilot study was to compare the reduction in gingival bleeding and plaque in subjects using a water flosser or interdental brush, each combined with a manual toothbrush. METHODS: Twenty-eight subjects completed the study. Subjects were randomly assigned to one of two groups: Waterpik® Water Flosser (WF) plus manual toothbrush or interdental brushes (IDBs) plus a manual toothbrush. Bleeding on probing (BOP) was measured at six sites and reported for whole mouth, lingual, facial, and interproximal areas. Plaque data were measured using the Rustogi Modification of the Navy Plaque Index (RMNPI) and were reported for whole mouth, approximal, marginal, facial, and lingual areas. Subjects received verbal and written instructions on the use of their interdental product and demonstrated proficiency prior to starting the study. RESULTS: There were no differences between the groups for BOP or RMNPI at baseline. Both groups demonstrated a significant reduction in BOP and RMNPI for all regions and areas measured from baseline to two weeks. The WF was more effective than the IDBs for BOP whole mouth (56%), facial (44%), approximal whole mouth (53%), and approximal facial (41%). Post hoc power analysis showed that the sample size was not adequate to detect a significant difference between groups for lingual and marginal assessments for BOP or any area for RMNPI. CONCLUSIONS: The Waterpik Water Flosser is more effective than IDBs for reducing gingival bleeding over two weeks.

Comparison of Water Flosser and Interdental Brush on Plaque Removal: A Single-Use Pilot Study.

OBJECTIVES: The purpose of this randomized, single-use, single-blind, two-group, parallel pilot study was to compare the plaque removal ability of a water flosser and interdental brush when used in combination with a manual toothbrush. METHODS: Twenty-eight (28) subjects completed the study. Subjects were randomly assigned to one of two groups: Waterpik®Water Flosser (WF) plus manual tooth brushing or interdental brushes (IDB) plus manual tooth brushing. Pre-cleaning plaque scores were obtained using the Rustogi Modification of the Navy Plaque Index (RMNPI). Subjects were instructed on the use of their interdental product. Post-cleaning scores were obtained after a supervised brushing and use of the interdental device. Scores were recorded for whole mouth, marginal, approximal, facial, and lingual regions for each subject. RESULTS: There were no differences between the groups for pre-cleaning plaque scores for whole mouth, marginal, approximal, facial, or lingual regions. Both groups showed significant reductions in plaque from baseline for all areas measured (p < 0.001). The WF group was significantly more effective than the IDB group for removing plaque from all areas measured. Specifically, the WF was 18% more effective for whole mouth and marginal areas, 20% for approximal areas, 11% for facial areas, and 29% for lingual areas. CONCLUSIONS: The Waterpik Water Flosser and manual toothbrush removes significantly more plaque from tooth surfaces (whole mouth, marginal, approximal, facial, and lingual) than interdental brushes and a manual toothbrush after a single use.

An Eight-Week Clinical Evaluation of an Oscillating-Rotating Power Toothbrush with a Brush Head Utilizing Angled Bristles Compared with a Sonic Toothbrush in the Reduction of Gingivitis and Plaque.

OBJECTIVE: To evaluate and compare the efficacy of an oscillating-rotating (O-R) power toothbrush with a brush head utilizing angled bristles to a marketed sonic toothbrush in the reduction of plaque and gingivitis over an eight-week period. METHODS: This study used a randomized, examiner-blind, single-center, two-treatment, parallel group, eight-week design. Subjects with mild-to-moderate plaque and gingivitis were evaluated for baseline whole mouth, gingival margin, and approximal plaque, gingivitis, and gingival bleeding. Clinical assessments were performed using the Modified Gingival Index, Gingival Bleeding Index, and the Rustogi Modified Navy Plaque Index. Subjects received either the O-R brush (Oral-B Professional Care 1000 [D16u] with Oral-B CrossAction brush head [EB50]) or the sonic brush (Sonicare DiamondClean with the standard DiamondClean brush head). Subjects brushed twice daily for two minutes per brushing with the assigned brush and a standard fluoride dentifrice for eight weeks before returning for plaque and gingivitis evaluations using the same methods. Prior to baseline and Week 8 measurements, participants abstained from oral hygiene for 12 hours. RESULTS: One hundred and forty-eight subjects completed the study; 75 in the O-R group and 73 in the sonic group. Both brushes demonstrated statistically significant reductions in plaque and gingivitis over the eight-week study period (p < 0.00 1). The O-R brush was statistically significantly more effective in reducing plaque and gingivitis than the sonic brush. Whole mouth, gingival margin, and approximal plaque reductions were 27.7%, 46.8%, and 29.3% greater, respectively, compared with the sonic brush, while the reductions in gingivitis, gingival bleeding, and number of bleeding sites were 34.6%, 36.4%, and 36.1% greater, respectively, for the O-R brush than for the sonic brush (p < 0.001 for all six measures). No adverse events were observed for either brush. CONCLUSION: The plaque and gingivitis reductions for the O-R power brush incorporating the angled-bristled brush head were significantly greater than for the sonic power brush.

Response of chronic gingivitis to hygiene therapy and experimental gingivitis. Clinical, microbiological and metabonomic changes.

PURPOSE: To compare the clinical, microbiological and metabonomic profiles of subjects with high and low levels of chronic gingival bleeding during a controlled oral hygiene regimen intervention including sequential phases of rigorous therapeutic oral hygiene followed by experimental gingivitis (EG). METHODS: Two cohorts of qualified study subjects with differences in gingival bleeding on probing levels at their baseline clinical examination were entered into the study. These two cohorts were followed through three separate study phases including a 1-week baseline phase, a 2-week phase of rigorous oral hygiene including dental prophylaxis, and a 3-week EG phase of no oral hygiene to encourage relapse of gingivitis. The 58 subjects were assessed during each phase of the study for clinical presentation of gingivitis and concurrently had plaque sampled for real-time polymerase chain reaction (RTPCR) microbiological characterization and salivary lavage samples for 'systems biology' metabonomics assessment by 1H-NMR. RESULTS: Subjects presenting with different levels of gingival bleeding on probing when they entered the study responded differently to rigorous oral hygiene and EG. Specifically, the high bleeding cohort responded sluggishly to rigorous oral hygiene and exhibited markedly greater relapse to gingivitis during EG. RTPCR analysis showed changes in bacterial populations that were associated with study phases, particularly the increases in putative periodontal pathogens during EG. However, the microbiological profiles of high- and low-susceptibility gingival bleeding patients were largely similar. Metabonomic analysis likewise revealed significant changes in metabolite composition during study phases associated with differences in plaque toxicity, especially the short chain carboxylic acids propionate and n-butyrate, which tracked clinical changes in gingivitis severity. Systems analysis of metabonomic changes suggested differences between cohorts, although analysis to date has not elucidated whether these differences are causative (population predictive) or simply diagnostic of clinical status within populations.

Efficacy of Two Interdental Cleaning Devices on Clinical Signs of Inflammation: A Four-Week Randomized Controlled Trial.

OBJECTIVE: The purpose of this study was to compare the reduction of the clinical signs of inflammation by two power interdental cleaning devices combined with a manual toothbrush. METHODS: Sixty-nine subjects completed this randomized, four-week, single-blind, two-group, parallel clinical study. Subjects were randomly assigned to one of two treatment groups: Waterpik Water Flosser (WF) plus a manual toothbrush; or Sonicare Air Floss Pro (AFP) plus a manual toothbrush. All subjects received both written and verbal instructions and demonstrated proficiency prior to starting the study. Instructions were reviewed at the two-week visit (W2). Data were evaluated for whole mouth, lingual, and facial areas for bleeding on probing (BOP) and Modified Gingival Index (MGI). Plaque data were recorded for whole mouth, lingual, facial, approximal, and marginal areas of the tooth using the Rustogi Modification of the Navy Plaque Index (RMNPI). BOP, MGI, and RMNPI were scored at baseline (BSL), two weeks, and four weeks (W4). RESULTS: Both groups showed significant reductions in BOP and MGI from baseline for all regions and time points measured (p < 0.001). Both groups showed significant reductions from baseline for all areas at W4 for RMNPI (p < 0.001). The WF group was significantly more effective than the AFP group at reducing bleeding and gingivitis for all areas measured at all time points. At W4, the WF group was 54% more effective for bleeding and 32% for gingivitis (p < 0.001). Plaque accumulation was significantly less at W4 for the WF group compared to the AFP group (28%, p 0.017). CONCLUSIONS: The Waterpik Water Flosser is significantly more effective than the Sonicare Air Floss Pro for reducing clinical signs of inflammation.

A six-week clinical evaluation of the plaque and gingivitis efficacy of an oscillating-rotating power toothbrush with a novel brush head utilizing angled CrissCross bristles versus a sonic toothbrush.

OBJECTIVE: To compare the efficacy of an oscillating-rotating power toothbrush with a novel brush head incorporating angled CrissCross bristles (Oral-B Triumph with SmartGuide with Oral-B CrossAction brush head) versus a sonic toothbrush (Sonicare DiamondClean) for plaque and gingivitis reduction over a six-week period. METHODS: This was a single-center, randomized, examiner-blind, two-treatment, parallel group study involving 65 subjects per group. Subjects presenting with mild-to-moderate gingivitis at Baseline were randomly assigned to either the oscillating-rotating brush or the sonic brush. They were instructed to use their assigned toothbrush and a standard fluoride dentifrice for two minutes twice daily at home for six weeks. Gingivitis and plaque were assessed at Baseline and Week 6 using the Modified Gingival Index (MGI), Gingival Bleeding Index (GBI), and Rustogi Modified Navy Plaque Index (RMNPI). Data were analyzed using an Analysis of Covariance (ANCOVA), with baseline as the covariate. Subjects also completed a consumer perception questionnaire to evaluate their brushing experience. RESULTS: One-hundred and thirty subjects were enrolled in the study and randomized to treatment. Sixty-four subjects per group completed the trial. Both brushes produced statistically significant reductions in gingivitis and plaque measures at Week 6 relative to Baseline (p < 0.001 for all). The oscillating-rotating brush with the novel brush head demonstrated statistically significantly greater reductions in all gingivitis and plaque measures compared to the sonic toothbrush. The benefits for the oscillating-rotating brush over the sonic brush were 32.6% for gingivitis, 35.4% for gingival bleeding, 32% for number of bleeding sites, 22% for whole mouth plaque, 24.2% for gingival margin plaque, and 33.3% for approximal plaque (p < or = 0.001 for all measures except gingival margin plaque, where p = 0.018). Analysis of the consumer perception questionnaire results showed subjects using the oscillating-rotating brush rated it higher for overall use experience and key attributes related to cleaning, gentleness, and brush head shape/size versus subjects in the sonic brush group. There were no adverse events reported or observed for either brush. CONCLUSION: This six-week randomized, examiner-blind, comparative clinical study showed the oscillating-rotating toothbrush, with a novel brush head incorporating angled CrissCross bristles, was significantly better than an advanced sonic power toothbrush at reducing gingival inflammation and bleeding, as well as reducing whole mouth plaque, plaque along the gumline, and in the approximal regions.

Evaluation of the plaque removal efficacy of a water flosser compared to string floss in adults after a single use.

OBJECTIVE: To compare the plaque removal efficacy of a water flosser to string floss combined with a manual toothbrush after a single use. METHODS: Seventy adult subjects participated in this randomized, single-use, single-blind, parallel clinical study. Subjects were assigned to one of two groups; Waterpik Water Flosser plus a manual toothbrush (WF) or waxed string floss plus a manual toothbrush (SF). Each participant brushed for two minutes using the Bass technique. The WF group added 500 ml of warm water to the reservoir and followed the manufacturer's instructions, and the SF group used waxed string floss between each tooth, cleaning the mesial and distal surfaces as instructed. Subjects were observed to ensure they covered all areas and followed instructions. Scores were recorded for whole mouth, marginal, approximal, facial, and lingual regions for each subject using the Rustogi Modification of the Navy Plaque Index. RESULTS: The WF group had a 74.4% reduction in whole mouth plaque and 81.6% for approximal plaque compared to 57.7% and 63.4% for the SF group, respectively (p < 0.001). The differences between the groups showed the water flosser was 29% more effective than string floss for overall plaque removal and approximal surfaces specifically (p < 0.001). The WF group was more effective in removing plaque from the marginal, lingual, and facial regions; 33%, 39%, and 24%, respectively (p < 0.001). CONCLUSION: The Waterpik Water Flosser and manual toothbrush is significantly more effective than a manual brush and string floss in removing plaque from tooth surfaces.

A 12-week clinical comparison of an oscillating-rotating power brush versus a marketed sonic brush with self-adjusting technology in reducing plaque and gingivitis.

OBJECTIVE: The aim of this investigation was to assess the comparative gingivitis and plaque reduction efficacy of a leading oscillating-rotating power toothbrush and a recently introduced sonic toothbrush in adults with gingivitis. METHODS: This was a 12-week, randomized and controlled, parallel group, examiner-blind, single-center clinical study of 130 adults with pre-existing gingivitis and plaque. At baseline, the Modified Gingival Index (MGI), Gingival Bleeding Index (GBI), and total number of bleeding sites were assessed, along with plaque levels (whole mouth, gingival margin, and interproximal) via the Rustogi Modified Navy Plaque Index (RMNPI). Qualified subjects were randomly assigned to one of two power toothbrush test groups: the Oral-B Triumph with SmartGuide (marketed in the United States as the Oral-B Professional Care SmartSeries 5000 [D34]) oscillating-rotating brush, or the Colgate ProClinical A1500 (also marketed as elmex ProClinical) sonic brush. Subjects brushed at home for two minutes twice daily with their assigned power toothbrush and a marketed sodium fluoride dentifrice, and were reevaluated for gingivitis at Week 4 and Week 12 via the MGI, GBI, and total number of bleeding sites, and for plaque reduction via the RMNPI. RESULTS: Ninety-seven percent (97%) of the 130 enrolled subjects completed the trial and 62 and 65 subjects in the oscillating-rotating and sonic brush groups, respectively, had evaluable data for analysis. Statistically significant mean reductions in all three gingivitis parameters and plaque relative to baseline were seen at both Weeks 4 and 12 with unsupervised use of both test toothbrushes (p < 0.001). The oscillating-rotating power brush provided statistically significantly superior reductions compared to the sonic brush in mean adjusted MGI (31% and 29% at Weeks 4 and 12, respectively; p < 0.001), GBI (17% at Week 12; p = 0.047), and total number of bleeding sites (48% and 30% at Weeks 4 and 12, respectively; p = 0.002), and produced statistically significantly greater relative mean adjusted plaque reductions for RMNPI whole mouth plaque (38% and 24% at Weeks 4 and 12, respectively; p < 0.001), gingival margin plaque (36% at Week 4; p = 0.004), and interproximal plaque (39% and 26% at Weeks 4 and 12, respectively; p < 0.001). Both power toothbrushes were well-tolerated. CONCLUSION: An advanced oscillating-rotating power toothbrush produced substantial, statistically superior reductions in plaque and gingivitis via multiple outcome measures compared to a new sonic toothbrush after both four weeks and 12 weeks of tooth brushing.

Evaluation of anti-gingivitis benefits of stannous fluoride dentifrice among triclosan dentifrice users.

PURPOSE: To evaluate the anti-gingivitis benefits of a 0.454% highly bioavailable stannous fluoride dentifrice (SnF2) relative to a 0.3% triclosan/copolymer dentifrice (triclosan/copolymer) among triclosan/copolymer dentifrice users with residual gingivitis. METHODS: This was a randomized, controlled, double-blind, parallel group, 2-month clinical study. Self-reported triclosan/copolymer dentifrice users were recruited and provided with triclosan/copolymer dentifrice to use for 1 month. After this 1-month acclimation period, subjects who had residual gingivitis at the baseline visit were randomized to either the SnF2 dentifrice or the triclosan/copolymer dentifrice (positive control). Subjects performed their treatment unsupervised using their assigned dentifrice following manufacturers' usage instructions for 2 months. The Gingival Bleeding Index (GBI) and Modified Gingival Index (MGI) were used to measure gingivitis benefits at baseline and Month 2. An analysis of covariance was performed to compare treatment groups for the post-baseline scores as well as change from baseline, with the baseline score as a covariate. All comparisons were two-sided at the 0.05 level of significance. RESULTS: A total of 150 subjects were randomized to treatment. Both treatment groups experienced significant reductions in number of bleeding sites, gingival bleeding index (GBI), and gingival inflammation (MGI) relative to baseline (P < 0.001). At Month 2, the SnF2 dentifrice group demonstrated significantly lower adjusted mean scores versus the triclosan/copolymer group for number of bleeding sites, GBI, and MGI (P < 0.001). Between-treatment group comparisons for change from baseline values showed that the improvement in number of bleeding sites from baseline for the SnF2 group was 49% greater versus that of the triclosan/copolymer group (P < 0.001), and the GBI and MGI improvements from baseline for the SnF2 group were 48% and 37%, greater, respectively, relative to the triclosan/copolymer group (P < 0.001).

Evaluation of a new multi-directional power toothbrush versus a marketed sonic toothbrush on plaque and gingivitis efficacy.

PURPOSE: To evaluate the plaque- and gingivitis-reducing efficacy of a newly developed multi-directional power toothbrush in comparison to a commercially-available sonic power toothbrush. METHODS: Adult subjects with mild-to-moderate gingivitis were eligible for this 4-week, randomized and controlled, single-center, examiner-blinded, parallel group study. At baseline, plaque and gingivitis status was assessed with the Rustogi Modified Navy Plaque Index (RMNPI), Lobene Modified Gingival Index (MGI), and Gingival Bleeding Index (GBI). Subjects meeting all eligibility criteria were randomly assigned to one of two power toothbrushes: a novel multi-directional power toothbrush (Oral-B Professional Deep Sweep TRICLEAN 1000 also marketed as Oral-B TriZone) or the marketed sonic control toothbrush (Philips Sonicare Essence 5500). A single supervised brushing occurred onsite at baseline; thereafter toothbrushing was conducted twice daily at home in accordance with manufacturer instructions using the assigned power brush. At 4 weeks post-baseline, subjects returned for MGI, GBI, and RMNPI evaluations to determine the plaque and gingivitis efficacy of the respective brushes. RESULTS: All 130 subjects completing the trial were evaluable. Both the novel multi-directional power and sonic control brushes produced significant mean reductions in gingivitis, gingival bleeding and plaque (whole mouth and region-specific) at Week 4 in comparison to baseline (P < 0.001). The new multi-directional power brush performed statistically significantly better (P < or = 0.001) in all efficacy measures after 4 weeks ofbrushing, providing superior adjusted mean relative reduction benefits versus the sonic control brush of 48% for MGI, 52% for GBI, 26% for whole mouth RMNPI, 58% for gingival margin RMNPI plaque, and 33% for interproximal (approximal) RMNPI plaque. Both toothbrushes were well-tolerated.