1. Assessment of the effects of a stannous fluoride dentifrice on gingivitis in a two-month positive-controlled clinical study.
- Author
-
He T, Barker ML, Biesbock AR, Sharma NC, Qaqish J, and Goyal CR
- Subjects
- Adolescent, Adult, Aged, Analysis of Variance, Dentifrices chemistry, Double-Blind Method, Drug Combinations, Female, Humans, Male, Maleates therapeutic use, Middle Aged, Periodontal Index, Polyvinyls therapeutic use, Prospective Studies, Silicic Acid therapeutic use, Toothpastes therapeutic use, Triclosan therapeutic use, Young Adult, Dentifrices therapeutic use, Gingivitis prevention & control, Phosphates therapeutic use, Tin Fluorides therapeutic use
- Abstract
Objective: The purpose of this study was to evaluate the anti-gingivitis effectiveness of a 0.454% stannous fluoride test dentifrice relative to a marketed positive-control triclosan-containing dentifrice in adults with gingivitis., Methods: This was a two-month, randomized and controlled, double-blind, parallel group, single-center investigation involving 150 adults with existing mild to moderate gingivitis. Pre-treatment gingivitis levels were assessed at baseline using the Lobene Modified Gingival Index (MGI) and the Gingival Bleeding Index (GBI). Qualified subjects were randomly assigned to either a 0.454% stannous fluoride test dentifrice or a marketed, positive-control 0.30% triclosan/copolymer dentifrice. Subjects then brushed for two months unsupervised in the home setting with their assigned dentifrice per manufacturer's instructions. At Month 2, subjects were re-evaluated for gingivitis via MGI and GBI examinations., Results: All 150 enrolled subjects completed the trial and were evaluable. Both the stannous fluoride test and triclosan/copolymer control dentifrices provided statistically significant reductions in average MGI, GBI, and number of bleeding sites relative to pre-treatment (p < 0.0001) at Month 2. The adjusted mean improvement from baseline at Month 2 for the stannous fluoride test dentifrice group was 65% greater for number of bleeding sites, 62% greater for GBI, and 45% greater for MGI compared to the triclosan/copolymer positive-control group, with groups differing significantly (p < 0.0001) via each of the three gingivitis measures. Both dentifrices were well-tolerated., Conclusion: An advanced stannous fluoride test dentifrice provided superior reductions in gingival inflammation and gingival bleeding compared to a commercially available triclosan/copolymer positive-control dentifrice after two months of tooth brushing.
- Published
- 2012