Objective: This randomized and controlled, blinded, 2-period crossover clinical trial was conducted to assess cumulative breath benefits with twice daily use of 0.454% stabilized stannous fluoride (SnF2) dentifrice with sodium hexametaphosphate relative to 0.243% sodium fluoride (NaF) negative control dentifrice over a 4-week period. Methods: Twenty healthy adult subjects were randomly assigned to one of two sequences specifying the order of use of the test dentifrices for each of the 4-week treatment periods. Oral malodor was measured using a halimeter to monitor volatile sulfur compounds (VSCs) at Hour 0, and again at 3 and 8 hours post-brushing on Visit Days 0, 7, 14, 21 and 28 of each treatment period. Gingival microbial sampling to quantitate total facultative anaerobes and Gram-negative anaerobes was conducted at Hour 0, 3 and 8 hours on Day 0, 7, 14 and 28. A 1-week washout period was scheduled between periods. All VSC data and mean log10 cfus for the microbial populations generated at individual time points were evaluated via analysis of covariance (ANCOVA). Trends over time were assessed using a mixed model Analysis of Variance. All comparisons were tested using a two-sided 0.10 level of significance. Results: The SnF2 dentifrice provided significantly superior reductions in VSCs relative to the NaF negative control with a statistically significant trend for the 8 hour time points to decrease over 4 weeks for the SnF2 dentifrice (p=0.01). The mean number of total facultative anaerobes and Gram-negative anaerobes for the SnF2 dentifrice were statistically significantly lower than the NaF negative control by 4 weeks (p<0.01). Conclusion: This research demonstrates the ability of the 0.454% stabilized stannous fluoride dentifrice with sodium hexametaphosphate to deliver superior breath benefits relative to the NaF negative control by monitoring of volatile sulfur compounds and microbial populations over a 4 week usage period.

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