The objective of this 2-month clinical study was to compare the efficacy of the two therapeutic dentifrices in the reduction of gingivitis among previous 0.3% triclosan dentifrice users with residual gingivitis.
This was a randomized, controlled, double-blind, parallel group, 2-month clinical study. Self-reported 0.3% triclosan dentifrice users were recruited and were provided with the 0.3% triclosan dentifrice to use for a month. Subjects who had residual gingivitis at the baseline visit were randomized into two treatment groups: a highly bio-available 0.454% Stannous fluoride dentifrice and a 0.3% triclosan dentifrice. Subjects performed their treatment unsupervised using their assigned dentifrice following manufacturers’ usage instructions for 2 months. The Modified Gingival Index (MGI) and Gingival Bleeding Index (GBI) were used to determine gingivitis benefits at baseline and month 2. An analysis of covariance were performed to compare treatment groups for the post baseline scores as well as change from baseline, with the baseline score as a covariate. All comparisons were two-sided at the 0.05 level of significance.
A total of 150 subjects were enrolled. Both treatment groups experienced significant reductions in gingival inflammation (MGI) and gingival bleeding (GBI) relative to baseline (p<0.001). At Month 2, the stannous fluoride dentifrice group demonstrated significantly lower adjusted mean scores versus the positive control for both MGI and GBI (p<0.0001). Between-treatment group comparisons for change from baseline values showed the gingival bleeding improvement from baseline for the stannous fluoride group was 48% greater versus that of the positive control (p<0.0001), and gingival inflammation improvement from baseline for the stannous fluoride group was 37% greater relative to the positive control (p<0.001).
The 0.454% Stannous fluoride dentifrice was significantly more efficacious than the 0.3% triclosan dentifrice in reducing gingivitis after 2 months among the triclosan users with residual gingivitis.
Keywords: Clinical trials, Dentifrices, Gingivitis, Human and Oral hygiene