2-Month Gingivitis Treatment Comparison of Stannous Fluoride and Triclosan/Copolymer Dentifrices

Objectives: The present clinical trial compared the treatment of gingivitis for a 0.454% stannous fluoride dentifrice relative to a positive control dentifrice after 2 months use.  Methods: This randomized, positive-controlled, double-blind, parallel-group study enrolled 200 healthy adult volunteers assigned equally to either a highly bioavailable 0.454% stannous fluoride dentifrice or a 0.3% triclosan/copolymer 0.23% sodium fluoride dentifrice (positive control) each used according to manufacturers' instructions.  Subjects brushed with the assigned dentifrice using a soft manual toothbrush for 2 months.  Whole-mouth sum of Gingival Bleeding Index (GBI), number of Bleeding Sites (bleeding), and average Modified Gingival Index (inflammation) scores were obtained at Baseline and Month 2, and groups were compared for change from baseline using analysis of covariance methods.  Results:   Mean age was 38 years ranging from 19 to 79, and groups were balanced (p>0.36) on demographics and baseline gingivitis scores with overall means (SD) of 15.85 (10.41) for GBI, 15.56 (9.96) for bleeding, and 2.085 (0.094) for inflammation.   At 2 months, 196 subjects completed the research, and both the stannous fluoride dentifrice group and the positive control group demonstrated a statistically significant (p<0.001) reduction versus baseline for each gingivitis measure.  At Month 2, the adjusted mean improvement from baseline for the stannous fluoride group was 60% greater for GBI, 62% greater for bleeding, and 45% greater for inflammation versus the positive control.  Groups differed significantly (p<0.001) for each gingivitis measure at Month 2.  Conclusions: This randomized controlled clinical trial demonstrated superior 2-month treatment of gingivitis for a 0.454% stannous fluoride dentifrice relative to a 0.3% triclosan/copolymer 0.23% sodium fluoride dentifrice.