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ABSTRACT: To evaluate the efficacy of an advanced rotation/oscillation power toothbrush (Oral-B Triumph with SmartGuide) relative to a new sonic power toothbrush (Sonicare DiamondClean) in the reduction of gingivitis and plaque over a period of 12 weeks.
This was a single-center, open-label, examiner-blind, two-treatment, parallel group, randomized study in which subjects brushed with their assigned toothbrush and a marketed dentifrice for 2 minutes twice daily at home for 12 weeks. Gingivitis and plaque were evaluated at baseline, Week 6 and Week 12 using the Modified Gingival Index (MGI), Number of Bleeding Sites, and Rustogi Modification of the Navy Plaque Index (RMNPI). Safety was also assessed at every visit. At the end of the study, subjects completed a consumer questionnaire to evaluate their brushing experience.
In total, 130 subjects were randomized to treatment and completed the study (65 per group). The rotation/oscillation group had higher gingivitis reductions from baseline at Weeks 6 and 12 by 31.9% and 32.3%, respectively, for MGI and by 43.4% and 34.9%, respectively, for number of bleeding sites than the sonic group. Group differences at both Weeks 6 and 12 were highly significant (P < 0.001) for both MGI and number of bleeding sites. The rotation/oscillation group had higher RMNPI plaque reductions from baseline at Weeks 6 and 12 by 15.8% and 19.3%, respectively, for whole mouth; by 24.1% and 30.4% at the gumline; and by 22.9% and 24.4% in the approximal regions, than the sonic group. Comparisons between groups at Week 12 were highly significant (P < or = 0.002) for all three mouth areas; group differences at Week 6 were significant (P < 0.05) for whole mouth and approximal RMNPI. Analysis of the questionnaire data showed that subjects using the rotation/oscillation brush rated it higher for several key attributes than subjects in the sonic group. There were no safety concerns with either brush.
American journal of dentistry 10/2012; 25(5):287-92. · 0.76 Impact Factor
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ABSTRACT: To determine the effectiveness of a new multi-directional power toothbrush in reducing plaque when compared to a standard manual toothbrush control in a single brushing design.
This was a randomized, replicate use, single-brushing, two-treatment, four-period, examiner-blinded crossover clinical trial at a single center. Qualified subjects entered an acclimation phase, after which they were randomly assigned to one of four treatment sequences specifying the order of use of the two test toothbrushes: a novel multi-directional power toothbrush with a 2-D drive (Oral-B Vitality TriZone) and an American Dental Association (ADA) reference soft manual brush. Subjects used each brush twice over the course of the trial. At each of the four period visits, after abstaining from oral hygiene for 24 hours, participants received a baseline (pre-brushing) Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) examination. They then brushed under supervision with the brush assigned for that period for 2 minutes (multi-directional power brush) or as customary (manual brush control). Subjects were then re-examined for TMQHPI post-brushing to determine the plaque removal efficacy of the respective brushes. A washout phase of 2-5 days separated treatment periods. TMQHPI scores were averaged on a per-subject basis, and analyzed using a mixed model analysis of covariance for a crossover design.
All 36 randomized subjects completed the study and were fully evaluable. Both the multi-directional power and manual control brushes produced statistically significant mean whole mouth TMQHPI plaque reductions compared to baseline (P < 0.001). Comparing the brushes, the power brush provided a 7.9% significantly superior mean whole mouth plaque reduction relative to the manual brush control (P= 0.003). Both toothbrushes were well-tolerated.
American journal of dentistry 09/2012; 25 Spec No A(A):10A-13A. · 0.76 Impact Factor
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ABSTRACT: To evaluate the efficacy of a novel multi-directional power toothbrush in reducing plaque and gingivitis relative to a standard manual toothbrush control.
This 4-week, randomized and controlled, single-center, parallel group, examiner-blinded clinical study enrolled adults with mild-to-moderate gingivitis. At baseline, pre-treatment gingivitis and plaque levels were assessed via the Lobene Modified Gingival Index (MGI), the Gingival Bleeding Index (GBI), and the Rustogi Modified Navy Plaque Index (RMNPI). Subjects qualifying were assigned randomly to one of two toothbrush groups: a novel multi-directional power toothbrush (Oral-B Professional Deep Sweep TRICLEAN 1000, also marketed as Oral-B TriZone) or a standard soft manual control toothbrush. Aside from a supervised brushing at baseline on-site, subjects brushed at home twice daily with their assigned test brush. After 1 week, subjects returned for RMNPI plaque evaluations. At Week 4, subjects were again recalled to evaluate toothbrush efficacy, and received MGI and GBI gingivitis and RMNPI plaque evaluations.
119 evaluable subjects completed the study. Both the novel power and manual control toothbrushes yielded statistically significant (P < 0.001) mean plaque reductions compared to baseline at Weeks 1 and 4 (except Week 1 manual brush gingival margin) and significant mean MGI and GBI gingivitis reductions (P < 0.001). Comparing the relative effectiveness of the test brushes, the novel multi-directional power brush produced significantly superior anti-gingivitis and anti-plaque reductions compared to pre-treatment relative to the manual control brush in every analysis at both time points. The Week 4 adjusted mean relative reductions favoring the multi-directional power brush were 3 and 1.49 times greater for whole mouth MGI and GBI, respectively (P < 0.001); and were 2.1, 4.7 and 2 times greater for the RMNPI whole mouth, gingival margin and interproximal regions, respectively (P < 0.001). Both toothbrushes were well-tolerated.
American journal of dentistry 09/2012; 25 Spec No A(A):14A-20A. · 0.76 Impact Factor
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ABSTRACT: 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.
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.
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.
American journal of dentistry 09/2012; 25 Spec No A(A):21A-26A. · 0.76 Impact Factor
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ABSTRACT: To assess the ability of a novel multi-directional power toothbrush to control plaque and gingivitis when compared to a marketed sonic power toothbrush control.
This was a randomized and controlled, examiner-blinded, parallel group, 8-week study at a single center, in adult subjects with mild-to-moderate gingivitis. Pre-treatment gingivitis levels and plaque coverage were evaluated at baseline using the Lobene Modified Gingival Index (MGI), the Gingival Bleeding Index (GBI), and the Rustogi Modified Navy Plaque Index (RMNPI). Qualified subjects were randomly assigned to either a novel multi-directional power toothbrush with a wireless display (Oral-B Professional Deep Sweep + SmartGuide TRICLEAN 5000, also marketed as Oral-B TriZone) or the marketed control sonic toothbrush (Philips Sonicare FlexCare). After a supervised brushing at the clinical site at baseline, subjects brushed unsupervised at home twice daily according to manufacturer instructions with the assigned test brush and standard sodium fluoride dentifrice. After 8 weeks, subjects were recalled to assess toothbrush efficacy via the MGI and GBI gingivitis and RMNPI plaque evaluations.
A total of 128 evaluable subjects completed the study. After 8 weeks of brushing, both test toothbrushes provided statistically significant reductions compared to baseline in mean whole mouth MGI and GBI, and in RMNPI whole mouth and interproximal (approximal) sites (P < 0.001). The novel multi-directional power brush consistently produced significantly superior anti-gingivitis and anti-plaque reductions relative to pre-treatment versus the sonic control brush: the Week 8 adjusted mean relative reductions were 30% and 29% greater for whole mouth MGI and GBI, respectively (P < 0.001); and were 44% and 77% greater for the RMNPI whole mouth and interproximal regions, respectively (P < or = 0.003). Both toothbrushes were well-tolerated.
American journal of dentistry 09/2012; 25 Spec No A(A):27A-32A. · 0.76 Impact Factor
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ABSTRACT: To compare the safety and efficacy of a novel sonic power toothbrush and a manual toothbrush in the reduction of gingivitis and plaque over a 4-week period.
This study employed a randomized two treatment, examiner-blinded, parallel group design. Subjects with evidence of gingivitis were randomly assigned to 4 weeks' twice daily home use of either the Oral-B Pulsonic sonic toothbrush or an ADA reference manual toothbrush. At baseline (Visit 1) and again after product use at Week 4, subjects received gingivitis evaluations with the Modified Gingival Index (MGI) and Gingival Bleeding Index (GBI) examinations, followed by plaque assessment using the Rustogi Modified Navy Plaque Index (RMNPI). For 12 hours before both visits, subjects abstained from all oral hygiene, and ceased eating, drinking and smoking 4 hours prior.
Both brushes significantly reduced gingivitis, gingival bleeding and plaque compared with baseline, and were well-tolerated by the 129 subjects completing the study. The sonic toothbrush was statistically significantly (P < 0.0001) more effective than the manual brush, with greater relative mean reductions in MGI, GBI and RMNPI of 11.9%, 62.3% and 46.5%, respectively.
American journal of dentistry 12/2010; 23(6):305-10. · 0.76 Impact Factor
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ABSTRACT: To compare the plaque removing efficacy of Oral-B Advantage 123 and Colgate 360 degrees manual toothbrushes on a single brushing after a 24-hour void in oral hygiene.
This study had a two-treatment (Advantage 123 versus Colgate 360 degrees), examiner-blind, randomized, four-period (visit) crossover design. At the first (baseline) visit, subjects received a plaque examination using the Rustogi Modified Navy Plaque Index (RMNPI) after which they were instructed to brush for 1 minute in their normal manner with their assigned toothbrush and a marketed dentifrice and unaided by access to a mirror. Post-brushing plaque was then assessed. At three further visits, each separated by a period of 3-8 days, brushes were assigned to subjects according to their treatment sequence and the same brushing and plaque grading procedure as at baseline was followed.
50 subjects were enrolled in the replicate single-use study; all were included in the analysis. Oral-B Advantage 123 was significantly better than Colgate 360 degrees at reducing whole mouth (P = 0.006), gingival margin (P = 0.010) and approximal (P = 0.040) plaque scores.
American journal of dentistry 07/2009; 22(3):189-92. · 0.76 Impact Factor
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ABSTRACT: To assess the extrinsic stain removal benefit of two different power toothbrushes: an experimental Oral-B Pulsonic rechargeable toothbrush and a positive control Sonicare FlexCare toothbrush.
This was a randomized, positive-controlled, examiner-blind, two-treatment, parallel group, two-week study. A Lobene stain index was performed at baseline on the facial surfaces of the anterior teeth. Subjects were randomized to one of two treatment groups: Pulsonic or FlexCare. Both groups were assigned the same fluoride dentifrice, and were instructed to brush their teeth twice per day for two minutes with the assigned toothbrush and dentifrice in front of a mirror. A further Lobene stain index was performed following two weeks of brushing.
A highly significant reduction (p < 0.001) in mean Lobene composite scores after two weeks was found for both the Pulsonic treatment group and the FlexCare treatment group (median reduction of 94.4% and 90.7%, respectively). Both treatment groups also showed a highly significant (p < 0.001) reduction in extent and intensity scores. No significant treatment group differences were seen in the reduction in mean Lobene scores (p > 0.1).
Both the experimental Pulsonic and the positive control FlexCare power toothbrushes showed highly effective stain removal efficacy relative to baseline following two weeks of brushing. Stain removal efficacy did not differ significantly between brushes.
The Journal of clinical dentistry 02/2009; 20(3):71-4.
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ABSTRACT: To assess extrinsic stain removal efficacy of a power toothbrush and a dental prophylaxis followed by the use of a standardized American Dental Association (ADA) reference manual toothbrush.
This was a randomized, positive-controlled, examiner-blind, parallel group, two-week study. A Lobene stain examination was performed at baseline. Subjects were randomized to one of two treatment groups: Group 1: Oral-B Vitality Pro White power toothbrush or Group 2: Subjects receiving a dental prophylaxis then using a standardized ADA reference manual toothbrush. Subjects were instructed to brush their teeth with the assigned toothbrush and a fluoride dentifrice in front of a mirror twice per day for 2 minutes. Stain was reassessed following 2 weeks of brushing.
A significant reduction (p <0.001) in mean Lobene composite scores after 2 weeks was found for Group 1 (90.6%) and Group 2 (94.4%). Both groups also showed a significant reduction (p <0.001) in extent and intensity scores. There was no significant group difference in reduction in mean Lobene composite scores (p>0.1).
The Oral-B Vitality Pro White power toothbrush showed effective stain removal at a level similar to receiving an oral prophylaxis followed by the use of an ADA reference manual toothbrush.
In this small study the Oral-B Vitality Pro White power toothbrush achieved statistically significant stain removal between dental visits.
The journal of contemporary dental practice 01/2008; 9(5):1-8.
