Assessment of the Effects of a Novel Stabilized Stannous Fluoride Dentifrice on Gingivitis in a Two-Month Positive-Controlled Clinical Study.

Objectives: The aim of this study was to compare the antibleeding/antigingivitis effectiveness of a newly formulated 0.454% stabilized stannous fluoride dentifrice and a marketed positive control triclosan-containing dentifrice in adults with mild-to-moderate gingivitis.

Methods: This single-center, two-month, randomized and controlled, double-blind, parallel group clinical trial involved adults with preexisting mild-to-moderate gingivitis. Baseline bleeding and gingivitis levels were assessed with the Gingival Bleeding Index (GBI) and Lobene Modified Gingival Index (MGI). Subjects were randomly assigned to either a new smooth formula 0.454% stabilized stannous fluoride test dentifrice (Crest® Pro-Health™) or a commercially available positive control 0.30% triclosan dentifrice (Colgate® Total®). Subjects brushed with their assigned dentifrice at home according to the manufacturer's instructions. At Month 2, subjects were re-evaluated for bleeding and gingivitis as at Baseline, with MGI and GBI evaluations.

Results: Of the 200 subjects randomized to treatment, 197 completed the study and had fully evaluable data. At Month 2, both the stannous fluoride and triclosan control dentifrices produced statistically significant reductions (p < 0.0001) in the mean number of bleeding sites, MGI, and GBI compared to Baseline. Use of this 0.454% stannous fluoride dentifrice resulted in 22% fewer bleeding sites versus the positive control triclosan dentifrice (p < 0.0001). Similarly, after two months of brushing, the stannous fluoride dentifrice group showed statistically significant lower mean MGI and GBI scores than subjects using the triclosan positive control dentifrice (p < 0.0001). Both dentifrices were well-tolerated.

Conclusions: Subjects brushing with a newly formulated stannous fluoride dentifrice had statistically significantly fewer bleeding sites and less gingivitis than those using a positive control triclosan dentifrice after two months.