Dental plaque is the primary cause of gingivitis. This study was to assess the anti-plaque efficacy of two therapeutic dentifrices using Digital Plaque Image Analysis (DPIA) Measures.
Method: This study employed a 2-treatment, parallel group, double blind, and randomized clinical study design. Ninety-six healthy adult subjects were enrolled into the study. The two treatments were: a 0.454% stannous fluoride dentifrice and a 0.3% triclosan dentifrice. Subjects were stratified and randomly assigned to one of the two treatment groups based on DPIA plaque measurements taken at the baseline visit. Subjects performed their treatment routine unsupervised using their assigned dentifrice following manufacturers’ usage instruction for the study duration. After three weeks of treatment, subjects had a final visit and had two replicate days of overnight pre-brushing DPIA images taken. The test groups were compared for mean plaque coverage using the analysis of covariance method with baseline as a covariate. All comparisons were two-sided at the 0.05 level of significance.
Result: Ninety-four subjects completed the study. Baseline mean plaque scores were balanced between the two treatment groups. The Week-3 adjusted over-night plaque value of the stannous fluoride group was 17% significantly lower than that of the triclosan group (p=0.04). Week-3 adjusted change from baseline plaque inhibition for the stannous fluoride group was 3 times greater versus that of the positive control group (p=0.04).
The research demonstrated the superior plaque inhibition effects of the 0.454% stannous fluoride dentifrice when compared to the 0.3% triclosan positive control dentifrice.
Keywords: Clinical trials, Dentifrices, Digital image analysis, Oral biology and Plaque