Study To Asses The Anti-Plaque Efficacy Of Two Marketed Dentifrices

Objectives: To evaluate the anti-plaque efficacy of two marketed dentifrice products. Methods: This was a controlled, randomized, double-blind, two-treatment, cross-over, 4 day partial brushing plaque study comprised of four study periods. Test dentifrice products included Crest® Pro-Health® containing 0.454% stannous fluoride and Colgate Total® containing 0.3% triclosan/copolymer.  Prior to the treatment phase each subject had a dental prophylaxis and underwent an acclimation period using Colgate Cavity Protection® for at least 1 week. Each treatment period consisted of 4 days and was separated by a washout period of 1 week. Treatments consisted of a baseline visit plaque evaluation using the Turesky Modification of Quigley Hein Index scored on 6 surfaces per tooth, followed by teeth polishing. Subjects were then randomly assigned to a treatment sequence and used their assigned products under supervision twice daily for 4 days.  Subjects brushed their lingual surfaces for 30 seconds, expectorated, and immediately swished with slurry of the assigned dentifrice for one minute. On Day 4 post treatment, subjects returned for a final plaque exam. The treatment and washout periods were repeated until all four treatment periods were completed. A general linear mixed model was used to analyze plaque scores with baseline used as a covariate. Whole mouth surfaces were considered the primary outcome measure. Statistical comparisons were two-sided with a significance level of 0.05. Results: Of 28 subjects randomized to treatment, 25 completed the study with evaluable data for analysis. Treatments were balanced for baseline whole mouth plaque measurement (p>0.14). The 0.454% stannous fluoride  dentifrice exhibited a Day 4 adjusted whole mouth mean (SE) plaque level of 1.57 (0.076), which was significantly lower (p=0.021) by 8.7% compared to 1.72 (0.076) for the triclosan/copolymer dentifrice. Conclusions: This study demonstrated greater anti-plaque efficacy of a 0.454% stannous fluoride dentifrice relative to 0.3% triclosan/copolymer dentifrice.