Method: This was a controlled, double-blind, randomized, 2-treatment, 3-period, cross-over 4-day partial brushing plaque study. Twenty-nine subjects received study treatments. Test products included a novel 0.454% stannous fluoride dentifrice and a negative control dentifrice. Subjects received a dental prophylaxis prior to study initiation. Each study period took place over a span of 4 days. Treatment periods were separated by a washout period of 7 days. In each period, baseline visit involved a plaque examination using the Turesky modification of Quigley Hein plaque index (TMQHPI) followed by a polishing of the teeth. Subjects were then randomly assigned to a treatment sequence and used the products twice daily for 4 days over each study period. Subjects brushed their lingual surfaces for 30 seconds. After expectoration, each brushing was immediately followed by swishing with the dentifrice slurry for 60 seconds. Clinical examinations were conducted 4-day post treatment. Plaque scores were analyzed using analysis of variance (ANOVA) for crossover studies. Statistical comparisons were two-sided with a significance level of 0.05.
Result: Treatments were balanced for the baseline plaque measurement (p>0.13) with an overall mean of 2.28 for the whole mouth surfaces. The 0.454% stannous fluoride dentifrice provided statistically significantly larger plaque reduction when compared to the negative control (p<0.0001). Adjusted mean plaque level of the stannous fluoride dentifrice group (2.01) was 15.2% (p<0.0001) lower than that of the negative control dentifrice group (2.37).
The research demonstrated the effectiveness of the novel 0.454% stannous fluoride dentifrice in the control of dental plaque relative to a negative control dentifrice.
Keywords: Clinical trials, Dentifrices, Human, Oral hygiene and Plaque