Tao He1, Sarah Li, Lily Sun. 1. P&G Health Care Research Center, 8700 Mason-Montgomery Road, Mason, OH 45040, USA. he.t@pg.com
Abstract
PURPOSE: To compare the plaque removal efficacy of two manual toothbrushes: Oral-B Exceed and Asian Colgate 36 degrees manual toothbrush. METHODS: The study used an examiner-blind, two-treatment, randomized, four-period (visits) crossover design. Subjects used each brush twice during the study. At the first visit, 41 subjects who met inclusion criteria and provided informed consent received a baseline plaque examination using the Turesky Modified Quigley-Hein Plaque Index. Subjects then used their assigned toothbrush for 1 minute with a marketed toothpaste without access to a mirror. Brushing was monitored. A post-brushing plaque exam was then performed. Subjects were rescheduled for their next visit in approximately 3 days. At visits 2, 3 and 4 the same disclosing, brushing and plaque grading procedures were followed. Subjects used their own products at home between visits. RESULTS:39 subjects presented data for all four study periods; two subjects missed one period each. Baseline plaque scores were balanced between the two groups. Adjusted mean plaque removal (baseline minus post-brushing) scores were 0.479 for the Exceed toothbrush and 0.425 for the Asian Colgate 360 degrees toothbrush (P < 0.002). This translates to 12.7% greater plaque removal for the Exceed toothbrush versus the Asian Colgate 360 degrees toothbrush. No adverse events were reported during the study.
RCT Entities:
PURPOSE: To compare the plaque removal efficacy of two manual toothbrushes: Oral-B Exceed and Asian Colgate 36 degrees manual toothbrush. METHODS: The study used an examiner-blind, two-treatment, randomized, four-period (visits) crossover design. Subjects used each brush twice during the study. At the first visit, 41 subjects who met inclusion criteria and provided informed consent received a baseline plaque examination using the Turesky Modified Quigley-Hein Plaque Index. Subjects then used their assigned toothbrush for 1 minute with a marketed toothpaste without access to a mirror. Brushing was monitored. A post-brushing plaque exam was then performed. Subjects were rescheduled for their next visit in approximately 3 days. At visits 2, 3 and 4 the same disclosing, brushing and plaque grading procedures were followed. Subjects used their own products at home between visits. RESULTS: 39 subjects presented data for all four study periods; two subjects missed one period each. Baseline plaque scores were balanced between the two groups. Adjusted mean plaque removal (baseline minus post-brushing) scores were 0.479 for the Exceed toothbrush and 0.425 for the Asian Colgate 360 degrees toothbrush (P < 0.002). This translates to 12.7% greater plaque removal for the Exceed toothbrush versus the Asian Colgate 360 degrees toothbrush. No adverse events were reported during the study.