Malgorzata Klukowska1, Julie M Grender, Hans Timm. 1. Dr. Malgorzata Klukowska, Procter & Gamble Health Care Research Center, 8700 Mason-Montgomery Road, Mason, OH 45040, USA. klukowska.m@pg.com
Abstract
PURPOSE: 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. METHODS: 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. RESULTS: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.
RCT Entities:
PURPOSE: 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. METHODS: 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. RESULTS: 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.
Authors: Shaima Bahammam; Chia-Yu Chen; Yoshiki Ishida; Akito Hayashi; Yutaka Ikeda; Hiroaki Ishii; David M Kim; Shigemi Nagai Journal: Int J Environ Res Public Health Date: 2021-12-12 Impact factor: 3.390