Xiping Feng1, Xi Chen, Richard Cheng, Lily Sun, Yuqing Zhang, Tao He. 1. Department of Preventive and Pediatric Dentistry, Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Key Basic Research Academic Discipline, China.
Abstract
PURPOSE: To determine the effectiveness of a novel stannous-containing sodium fluoride dentifrice in reducing malodor-causing volatile sulfur compound (VSC) levels versus a standard marketed fluoride (negative control) anti-caries dentifrice using pooled data from independent clinical trials. METHODS: Four randomized and controlled, evaluator-blinded, 3- or 4-period, 2-treatment crossover clinical studies were conducted at four separate centers in Asia and the United States in subjects with a baseline VSC score of > 100 ppb. Following a week-long acclimation period, subjects were randomly assigned to a treatment sequence specifying the order of use of a stannous-containing sodium fluoride dentifrice and a negative control dentifrice (Crest Cavity Protection). VSC levels were assessed at four time points using a Halimeter during each treatment period: (1) baseline prior to treatment; (2) 3-4 hours after baseline and a single brushing; (3) 24 hours post-baseline and after two total brushings ("overnight"/"morning breath"); and (4) 27-28 hours post-baseline following three total product uses. Brushing instructions were standardized and required two minutes of timed toothbrushing with the assigned dentifrice. Washout periods of at least 2 days separated the treatment periods. RESULTS:A total of 100 subjects were included in the meta-analysis. The stannous-containing dentifrice showed statistically significantly greater breath benefits via VSC reduction compared to the negative control dentifrice (P < 0.047) at all three time points. The stannous-containing dentifrice provided increasingly greater superior relative breath protection benefits of 7.7% at Hour 3-4 post-baseline, 10.6% after 24 hours ("overnight"/"morning breath"), and 24.5% at Hour 27-28. Similar malodor reduction benefits in favor of the stannous-containing dentifrice relative to the negative control were observed for each individual study.
RCT Entities:
PURPOSE: To determine the effectiveness of a novel stannous-containing sodium fluoride dentifrice in reducing malodor-causing volatile sulfur compound (VSC) levels versus a standard marketed fluoride (negative control) anti-caries dentifrice using pooled data from independent clinical trials. METHODS: Four randomized and controlled, evaluator-blinded, 3- or 4-period, 2-treatment crossover clinical studies were conducted at four separate centers in Asia and the United States in subjects with a baseline VSC score of > 100 ppb. Following a week-long acclimation period, subjects were randomly assigned to a treatment sequence specifying the order of use of a stannous-containing sodium fluoride dentifrice and a negative control dentifrice (Crest Cavity Protection). VSC levels were assessed at four time points using a Halimeter during each treatment period: (1) baseline prior to treatment; (2) 3-4 hours after baseline and a single brushing; (3) 24 hours post-baseline and after two total brushings ("overnight"/"morning breath"); and (4) 27-28 hours post-baseline following three total product uses. Brushing instructions were standardized and required two minutes of timed toothbrushing with the assigned dentifrice. Washout periods of at least 2 days separated the treatment periods. RESULTS: A total of 100 subjects were included in the meta-analysis. The stannous-containing dentifrice showed statistically significantly greater breath benefits via VSC reduction compared to the negative control dentifrice (P < 0.047) at all three time points. The stannous-containing dentifrice provided increasingly greater superior relative breath protection benefits of 7.7% at Hour 3-4 post-baseline, 10.6% after 24 hours ("overnight"/"morning breath"), and 24.5% at Hour 27-28. Similar malodor reduction benefits in favor of the stannous-containing dentifrice relative to the negative control were observed for each individual study.
Authors: Catarina Izidoro; João Botelho; Vanessa Machado; Ana Mafalda Reis; Luís Proença; Ricardo Castro Alves; José João Mendes Journal: Int J Environ Res Public Health Date: 2022-09-08 Impact factor: 4.614