The anti-plaque efficacy of a novel stannous-containing sodium fluoride dentifrice: A randomized and controlled clinical trial

摘要

Purpose: To evaluate the anti-plaque efficacy of a novel stannous-containing sodium fluoride dentifrice compared to a negative control regular anti-caries dentifrice and a positive control marketed triclosan-containing dentifrice. Methods: This was a randomized and controlled, single-center, double-blind, three-treatment, three-period, crossover clinical trial in generally healthy adults. A prophylaxis was followed by three 4-day treatment periods of limited brushing, each separated by an approximate 7-day washout phase. Subjects used the test dentifrice on Days 0-3 of each period according to their randomly assigned sequence; either Crest Cavity Protection (negative control); an experimental stannous-containing sodium fluoride dentifrice; or a marketed triclosan positive control (Colgate Total). A dental polishing was given at Day 0 of each treatment period, and subjects brushed the lingual surfaces only and then swished the entire dentition with a dentifrice slurry twice daily under supervision through Day 3. At baseline and Day 4 of each treatment period, plaque levels were assessed via the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI). Results: Twenty-eight fully evaluable subjects completed the trial. Both the experimental and positive control dentifrices provided significantly lower mean whole mouth TMQHPI plaque scores after treatment compared to the negative control: 11.4% lower for the experimental stannous-containing dentifrice and 8.4% for Colgate Total (P< 0.0001). The experimental stannous-containing dentifrice group resulted in directionally lower whole mouth plaque scores when compared to Colgate Total (P= 0.07). The experimental stannous-containing dentifrice had significantly lower mean plaque scores post-treatment at lingual sites compared with Total (P= 0.0355). All dentifrices were well-tolerated.