Clinical assessment of a manual toothbrush with CrissCross and tapered bristle technology on gingivitis and plaque reduction.

PURPOSE: The primary aim of this study was to evaluate the gingivitis-reduction efficacy of an experimental manual toothbrush with CrissCross and tapered bristle technology in comparison with a marketed control manual toothbrush with traditional design and non-tapered bristles. In addition, the study compared the two toothbrushes for plaque-reduction efficacy. METHODS: This was a randomized, controlled, parallel group, examiner-blind, single-center, 4-week clinical trial with adult subjects in good general health. All subjects had presence of gingivitis (at least 10 bleeding sites). The subjects were randomly assigned to one of two treatment groups: a manual toothbrush having CrissCross and tapered bristle technology (tapered group: Oral-B CrossAction Ultrathin manual toothbrush); or a traditional flat-trim design and regular non-tapered bristles (control group: Oral-B Indicator Soft 35 manual toothbrush). Subjects were instructed to brush twice-daily for 4 weeks with their assigned brush and a standard sodium fluoride dentifrice. At baseline, Week 2, and Week 4, gingivitis was assessed using the Mazza Modification of the Gingival Bleeding Index (Mazza GI) and pre-brushing whole-mouth plaque was measured using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI). RESULTS: 100 subjects (50 per group) were randomized to treatment and assessed at baseline, and 97 subjects (48 in the tapered group and 49 in the control group) completed the study. At both Weeks 2 and 4, both groups showed a significant (P< 0.005) reduction versus baseline in Mazza GI and number of bleeding sites, and the tapered group showed a significantly (P< 0.001) greater reduction from baseline for both these assessments compared to the control group. By Week 4 the tapered group showed a reduction from baseline of 17.9% in Mazza GI and 38.5% in the number of bleeding sites; the corresponding figures for the control group were 7.5% and 12.6%, respectively. Both groups showed a significant (P< 0.001) reduction versus baseline in TMQHPI by Week 4, with no significant (P=0.06) between-group difference. CLINICAL SIGNIFICANCE: The twice-daily use of a manual toothbrush with CrissCross design and tapered bristles had a statistically significantly greater gingivitis reduction compared to a manual toothbrush of traditional flat-trim design and regular non-tapered bristles, which could be a clinical advantage.

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.

A Comparison of Oral Hygiene Products and Professional Care: A six-week randomized clinical trial.

Purpose: To investigate the anti-gingivitis efficacy of a novel oral hygiene routine consisting of a two-step stannous fluoride dentifrice and hydrogen peroxide whitening gel system, an interactive oscillating-rotating electric toothbrush, and expanded polytetrafluoroethylene floss.Methods: A total of 52 participants (n=52;mean age 35.8±11.23 years) were enrolled in the study and randomized 1:1 to the experimental hygiene group or control (dental prophylaxis followed by use of standard sodium fluoride dentifrice and a manual toothbrush). Participants were instructed to brush twice daily; those in the experimental group were instructed to floss once daily. Oral examinations were conducted at Baseline, Week 2, Week 4, and Week 6.Results: Both groups experienced significant declines in the mean number of bleeding sites from Baseline at all time points, evident as early as Week 2. Bleeding sites continued to decline throughout the trial in the experimental group, whereas they showed an increasing trend between Weeks 2 and 6 in the control group. The experimental group had 55% fewer bleeding sites at Week 2, 85% fewer bleeding sites at Week 4, and 98% fewer bleeding sites at Week 6 (p<0.0001 for all) as compared to the control group. At Week 6, 84% of participants in the experimental group had no bleeding, while all participants in the control group had bleeding.Conclusion: The experimental oral hygiene group showed significantly greater reductions in gingival bleeding than the control oral hygiene group, with benefits seen as early as Week 2 and increasing over the six-week study.

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.

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

PURPOSE: To evaluate an oscillating-rotating power brush with a novel brush head utilizing angled bristle tufts versus a manual brush for plaque removal. METHODS: This was a single-center, randomized, open-label, examiner-blind, two-treatment, parallel-group study. Subjects brushed with their assigned toothbrush and a marketed dentifrice twice daily at home for 6 weeks. Plaque measurements were evaluated at baseline and week 6 using the Turesky Modified Quigley-Hein Plaque Index (TQHPI). Data was analyzed using the analysis of covariance (ANCOVA) with baseline as the covariate. RESULTS: Ninety-four subjects completed the study, with 46 in the manual group and 48 in the power group. The oscillating-rotating brush with the novel brush head demonstrated statistically significantly greater reductions in whole mouth and interproximal plaque measures compared to the manual toothbrush. The benefit for the oscillating-rotating brush over the manual control brush was 164.5% for whole mouth plaque and 167.4% for interproximal plaque (P < 0.001) measured 12 hours after brushing. Both brushes produced statistically significant reductions in plaque measures relative to baseline (P < 0.001 for both measures). There were no adverse events reported or observed for either brush. CONCLUSIONS: The oscillating-rotating brush with the novel brush head produced reductions in whole mouth and interproximal plaque more than twice that of the manual toothbrush.

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.

A randomized clinical trial evaluating gingivitis and plaque reduction of an oscillating-rotating power brush with a new brush head with angled bristles versus a marketed sonic brush with self-adjusting technology.

PURPOSE: To compare the efficacy of an oscillating-rotating power toothbrush with a novel brush head incorporating angled CrissCross bristles (Oral-B Pro 7000 SmartSeries and Oral-B CrossAction brush head) versus a marketed sonic toothbrush (Colgate ProClinical A1500 with the Triple Clean brush head) in the reduction of gingivitis and plaque over a 6-week period. METHODS: This was a single center, randomized, open label, examiner-blind, 2-treatment, parallel group study. Study participants who met the entrance criteria were enrolled in the study and randomly assigned to one of the two toothbrush groups. Study participants brushed with their assigned toothbrush and a marketed fluoride dentifrice for 2 minutes twice daily at home for 6 weeks. Gingivitis and plaque were evaluated at baseline and Week 6. Gingivitis was assessed using the Modified Gingival Index (MGI) and Gingival Bleeding Index (GBI) and plaque was assessed using the Rustogi Modified Navy Plaque Index (RMNPI). Data was analyzed using the ANCOVA with baseline as the covariate. RESULTS: In total, 130 study participants were randomized to treatment resulting in 64 study participants per group completing the study. Both brushes produced statistically significant (P < 0.001) reductions in gingivitis and plaque measures relative to baseline. The oscillating-rotating,brush with the novel brush head demonstrated statistically significantly (P < 0.05) greater reductions in all gingivitis measures, as well as whole mouth and interproximal plaque measures, compared to the sonic toothbrush. The benefit for the oscillating- rotating brush over the sonic brush was 21.3% for gingivitis, 35.7% for gingival bleeding, 34.7% for number of bleeding sites, 17.4% for whole mouth plaque, and 21.2% for interproximal plaque. There were no adverse events reported or observed for either brush.

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.

Comparative performance of two whitening systems in a dental practice.

OBJECTIVE: A randomized, controlled clinical trial was conducted to compare the safety and whitening efficacy of high-adhesion tooth-whitening strips with a marketed in-office professional tooth-whitening system. METHODS AND MATERIALS: This open-label study was conducted in a private dental practice, and adult volunteers were assigned (2:1) to either 9.5 percent hydrogen-peroxide whitening strips (Strip group) or an in-office light plus 25 percent hydrogen-peroxide whitening gel treatment (In-office group). The Strip group was instructed to treat the maxillary arch once daily for 30 minutes over a 20-day period, while the In-office group underwent professional application of light plus whitening gel in a single office visit. Whitening response was measured as change in yellowness (b*) and lightness (L*) at Day 21 using standardized digital images of the maxillary anterior teeth, while safety was assessed as tooth sensitivity and oral irritation occurrence. A total of 45 subjects enrolled, were randomized, and received treatment; 44 completed the study. RESULTS: At Day 21, significant improvement in b* and L* was noted in both groups (P≤0.001). The adjusted mean (SE) ΔL* in the Strip group (1.72 (0.104)) was significantly greater than that in the In-office group (1.17 (0.153)) (P = 0.005). Both test products were well tolerated. Overall, both the strip and in-office treatments resulted in significant tooth whitening.

Safety and efficacy of a high-adhesion whitening strip under extended wear regimen.

OBJECTIVES: This randomized, parallel group, single centre clinical trial was conducted to evaluate the safety and compare the whitening efficacy for an extended wear of an experimental 9.5% H2O2 high-adhesion whitening strip, relative to a marketed 10% H2O2 control strip. METHODS: Twenty-nine eligible adult volunteers were randomly assigned to either a treatment series with an experimental 9.5% H2O2 high-adhesion whitening strip at home for 2h, once a day, for 8 days; or a marketed 10% H2O2 whitening strip for 30 min, on a similar daily regimen. Tooth color/whitening progression was recorded under standardized lighting conditions at baseline, day 3, day 5, and day 9, via digital imaging. Outcomes were reported using the CIELAB system. Usage safety was also assessed at each follow-up visit. Whitening efficacy for each group was investigated using a paired-difference t-test. The treatment groups were compared among each other using the analysis of covariance, with the baseline value and age as the covariates. RESULTS: Both treatment groups demonstrated statistically significant mean color improvement from baseline for b* (yellow ness) and L* (lightness) at each post-baseline visit. In addition, the 2-h high-adhesion strips demonstrated significantly greater improvement in b* and L* relative to the 30-min strip group at each follow-up visit. CONCLUSIONS: The 2-h regimen for the 9.5% H2O2 high-adhesion whitening strip was more efficient for tooth whitening than the 30-min regimen of 10% H2O2 whitening strip. Both treatments were well tolerated and the use of the test products during the study time frame was considered safe. CLINICAL RELEVANCE: Extending the daily wear time of whitening strips can improve the efficacy of the treatment and ultimately shorten the length of the treatment without any significant adverse effects.