357 Effects of Manual Toothbrush with Flexing Elements on Gingivitis Reduction

Thursday, March 22, 2012: 2 p.m. - 3:15 p.m.
Presentation Type: Poster Session
P. AMINI1, J. QAQISH2, S. FARRELL3, J.M. GRENDER3, and P. CUNNINGHAM3, 1BioSci Research, Las Vegas, NV, 2BioSci Research America, Inc, Las Vegas, NV, 3Procter & Gamble Company, Mason, OH
Objectives: ,  This randomized, parallel-design, examiner-blinded clinical trial evaluated effects of a new manual tooth brush with flexing elements on gingivitis reduction relative to a positive control marketed manual toothbrush. Methods: , Sixty healthy adult volunteers with mild to moderate gingivitis were randomized to one of the two manual brushes: 1) new manual toothbrush with flexing elements (Oral-B Pro-Health Clinical Pro-Flex) as a test brush or 2) marketed Oral-B CrossAction Pro-Health manual toothbrush as a positive control. All subjects received regular cavity protection toothpaste (Crest Cavity Protection). Subjects brushed with their assigned products in their customary manner twice a day for 4 weeks. Gingivitis was assessed using Modified Gingival Index (MGI) and Gingival Bleeding Index (GBI) at Baseline, Week 2 and Week 4.  Results: , The mean age of study participants was 35.5 years, and 62% of subjects were female. The groups were balanced (p > 0.3) for age, gender, Baseline MGI and GBI scores. The mean Baseline MGI scores were 2.16 and 2.14, and the mean Baseline GBI scores were 0.108 and 0.095 for the test and the positive control brush, respectively. At each visit, both treatment groups demonstrated significant (p ≤ 0.003) reduction of MGI and GBI scores relative to Baseline. At the end of the 4-week treatment, use of the test brush resulted in 4.2% reduction of the mean MGI score and 25.9% reduction of the mean GBI score relative to baseline, while the corresponding percent reductions for the positive control brush were 4.7% and 36.8%. There were no significant differences between brushes in gingivitis reduction at 2 weeks or 4 weeks (p > 0.4). Both brushes were well-tolerated; no adverse events were reported. Conclusions: , Four-week use of a new manual toothbrush with flexing elements resulted in gingivitis reduction similar to that of a positive control marketed manual toothbrush.

Keywords: Clinical trials, Effectiveness, Gingivitis, Oral hygiene and Toothbrushes
Presenting author's disclosure statement: research funded by Procter & Gamble