Superior Anti-calculus Efficacy of an experimental 0.454% SnF2 Dentifrice

Objectives: To evaluate the anti-calculus efficacy and stain formation potential of an experimental 0.454% Stannous Fluoride (SnF2)/sodium hexametaphosphate dual-phase dentifrice. Methods: This was a 6-month, parallel groups, examiner-blind, randomized and controlled clinical trial in which the experimental dentifrice was compared to a marketed positive control (Colgate® Total™). Subjects received dental prophylaxis and then entered a 2 month run-in phase, during which they brushed unsupervised with a cavity protection dentifrice. At the end of the 2 months, subjects received Volpe Manhold Index (V-MI) calculus examination. Qualified subjects who formed a minimum of 1.5mm of calculus per tooth were re-prophied and randomly assigned to one of the two treatments. Subjects brushed unsupervised with their assigned product for 6 months, with V-MI, Lobene stain index and OST exams at Months 3 and 6. Analysis of covariance (ANCOVA) with treatment as a factor and baseline V-MI score as the covariate was used to assess treatment differences separately at Months 3 and 6. Results: Of the 80 subjects who were randomized to treatment, 77 completed the study. The mean calculus score for the experimental dentifrice group was statistically significantly lower than that of the Colgate Total group, at both Months 3 and 6 (p<0.0001). At both Months 3 and 6, the experimental dentifrice group had an adjusted mean 70% lower than that of the Colgate Total group. The mean stain score for the experimental dentifrice group was statistically significantly lower than that of the Colgate Total group, at Month 3 (p=0.01). There was no statistically significant difference between the two treatment groups at Month 6. Both test products were well tolerated. Conclusions: The research demonstrated superior anticalculus efficacy of the SnF2 dentifrice relative to the positive control dentifrice in a 6-month duration.