Anti-gingivitis effects of a novel 0.454% stabilized stannous fluoride dentifrice relative to a positive control.

PURPOSE: To compare the anti-gingivitis efficacy of a novel 0.454% stannous fluoride dentifrice to a commercially available positive control triclosan-containing dentifrice in a population of adults with gingivitis. METHODS: This single-center, randomized and controlled, double-blind, parallel group, 2-month trial enrolled 200 adults with mild-to-moderate gingivitis. At baseline, pre-treatment gingivitis levels were assessed with both the Lobene Modified Gingival Index (MGI) and the Gingival Bleeding Index (GBI). Subjects were randomly assigned to one of two test dentifrices: either 0.454% highly bioavailable stannous fluoride or the 0.30% triclosan positive control. Following at-home, unsupervised toothbrushing according to manufacturer's instructions with their assigned test dentifrice for 2 months, subjects were re-evaluated for gingivitis again via the MGI and GBI examinations. RESULTS: A total of 196 subjects completed the trial and were evaluable. At Month 2, both test dentifrices produced statistically significant reductions in number of bleeding sites, GBI, and MGI on average relative to pre-treatment (P< 0.0001). The Month 2 adjusted mean improvement from baseline for the stannous fluoride dentifrice group was 62% greater for number of bleeding sites, 60% greater for GBI, and 45% greater for MGI versus the triclosan/copolymer positive control group; groups differed significantly (P<0.0001) for each gingivitis measure at Month 2. Both dentifrices were well-tolerated.