Malgorzata Klukowska1, Julie M Grender2, Erinn Conde3, Kimberly R Milleman4, Jeffery L Milleman4. 1. Principal Clinical Scientist, Procter and Gamble Company, Mason, Ohio. 2. Research Fellow Statistician, Procter and Gamble Company, Mason, Ohio. 3. Clinical Trial Manager, Procter and Gamble Company, Mason, Ohio. 4. Director, Salus Research, Inc., Fort Wayne, Indiana.
Abstract
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.
RCT Entities:
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.