A clinical investigation of the efficacy of two dentifrices for controlling established supragingival plaque and gingivitis

Abstract

Objective: To assess the efficacy of a dentifrice containing 0.3% triclosan/2.0% polyvinylmethyl ether/maleic acid (PVM/MA) copolymer/0.243% sodium fluoride in a 17% dual silica base (Colgate Total Advanced Toothpaste-Test Dentifrice) for controlling established supragingival plaque and gingivitis, relative to that of a commercially available dentifrice containing 0.243% sodium fluoride in a silica base (Crest Cavity Protection Toothpaste-Control Dentifrice).

Methods: Following a baseline examination for supragingival plaque and gingivitis, qualifying adult male and female subjects from the Barcelona, Spain area were randomized into two treatment groups. Subjects were given a complete oral prophylaxis and instructed to brush their teeth twice daily (morning and evening) for one minute with their assigned dentifrice and a soft-bristled toothbrush. Examinations for supragingival plaque and gingivitis were repeated after three months and six months of product use.

Results: Ninety-four (94) subjects complied with the protocol and completed the study. Relative to the Control Dentifrice group, the Test Dentifrice group presented statistically significantly lower whole-mouth plaque index and gingival index scores (18.6% and 15.8%, respectively) after three months of product use. Similarly, relative to the Control Dentifrice group, the Test Dentifrice group exhibited statistically significant reductions in plaque index and gingival index scores measured on proximal sites (17.0% and 16.3%,respectively), and statistically significant reductions in plaque severity index and gingivitis severity index scores (22.2% and 46.9%, respectively) after three months of product use. Relative to the Control Dentifrice group, the Test Dentifrice group presented statistically significantly lower whole-mouth plaque index and gingival index scores (23.4% and 21.3%, respectively) after six months of product use. Similarly, relative to the Control Dentifrice group, the Test Dentifrice group exhibited statistically significant reductions in plaque index and gingival index scores measured on proximal sites (21.1% and 23.0%, respectively), and statistically significant reductions in plaque severity index and gingival severity index scores (27.1% and 64.5%, respectively) after six months of product use.

Conclusion: The overall results of this double-blind clinical study, conducted in accordance with the quantitative criteria established by the American Dental Association, support the conclusion that a dentifrice containing 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride in a 17% dual silica base is efficacious for the control of established supragingival plaque and gingivitis.