Breath malodor reduction with use of a stannous-containing sodium fluoride dentifrice: A meta-analysis of four randomized and controlled clinical trials

摘要

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'V'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'V'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.