To compare the efficacy of a 0.454% stannous fluoride dentifrice and a 0.3% triclosan dentifrice in the reduction of dental plaque over a 6-week period.
This study utilized a randomized, two-treatment, double-blinded, parallel group design. Subjects who met the entrance criteria were randomly assigned to 6 weeks’ unsupervised home use of either the 0.454% stannous fluoride dentifrice or a positive control 0.3% triclosan dentifrice. Subjects were instructed to brush following manufacturers’ usage instruction. At baseline and again after product use at Week 3 and Week 6, subjects received plaque assessment using the Rustogi Modified Navy Plaque Index (RMNPI). Subjects abstained from all oral hygiene from 11pm the night before their appointment, and ceased eating, drinking and smoking 4 hours prior. Between group comparisons used analysis of covariance (ANCOVA) by week and Repeated Measures Analysis overall. Statistical comparisons were two-sided with a significance level of 0.05.
A total of 120 subjects were enrolled into the study. The mean age was 37.5 years. Baseline mean plaque scores were balanced between the two treatment groups (p=0.8). Both dentifrices significantly reduced dental plaque compared with baseline (p<0.0001). The 0.454% stannous fluoride dentifrice was statistically significantly (p<0.0001) more effective than the 0.3% triclosan dentifrice, with greater relative mean reductions in RMNPI of 30%, 45%, and 36% at Week 3, Week 6, and for Week 3 and 6 combined, respectively. The Week 3 and 6 combined adjusted change from baseline plaque reduction for the stannous fluoride group was 3 times greater versus that of the positive control group (p<0.0001).
The 0.454% stannous fluoride dentifrice provided statistically significantly superior plaque reduction relative to 0.3% triclosan dentifrice.
Keywords: Clinical trials, Dentifrices, Human, Oral hygiene and Plaque