To evaluate the anti-plaque efficacy of a 0.454% stannous fluoride dentifrice relative to a 0.3% triclosan dentifrice in a 6-week clinical study.
Method:
This study utilized a randomized, two-treatment, double-blinded, parallel group design. Subjects who met the entrance criteria were randomly assigned to either the 0.454% highly bioavailable stannous fluoride dentifrice or a 0.3% triclosan control dentifrice (Colgate Total®). Subjects were instructed to brush twice daily unsupervised following manufacturers’ usage instructions. 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.
Result:
A total of 120 subjects were enrolled and 117 of them completed the study. Treatment groups were balanced (p>0.21) on age, ethnicity, and gender. Baseline mean RMNPI was 0.63 for both the stannous fluoride and the triclosan groups. Both dentifrices significantly reduced dental plaque compared with baseline (p<0.0001). Combing Weeks 3 and 6, the stannous fluoride dentifrice exhibited significantly (p=0.0006) lower mean whole mouth RMNPI relative to the triclosan control group. At each post-baseline Week 3 and Week 6 visit, the stannous fluoride dentifrice resulted in significantly (p<0.01) lower mean whole mouth RMNPI relative to the triclosan control group. In addition, the stannous fluoride dentifrice demonstrated significantly (p<0.03) lower mean plaque along the gingival margin and interproximally versus the triclosan control for each post-baseline visit and overall.
Conclusion:
The 0.454% stannous fluoride dentifrice provided significantly superior plaque reduction relative to 0.3% triclosan dentifrice over a 6-week period in hard-to-reach and whole mouth areas.