A randomized cross-over clinical trial to evaluate the effect of a 0.454% stannous fluoride dentifrice on the reduction of oral malodor.

PURPOSES: To compare the oral malodor protection efficacy of a 0.454% stannous fluoride dentifrice versus a negative control (0.243% sodium fluoride) using a sulfide monitor (halimeter) as the measurement. A secondary objective was to assess the effects of tongue brushing.

METHODS

This was a four-treatment, five-period, examiner-blinded, crossover, randomized study. Healthy subjects who met the entrance criteria were enrolled into the study. A 5-day acclimation period, in which subjects brushed twice daily in their customary manner with a standard sodium fluoride dentifrice, occurred prior to baseline. After baseline halimeter measurements, subjects were randomly assigned to one of four treatments (SnF2 dentifrice groups, with or without tongue brushing; negative control dentifrice groups, with or without tongue brushing) based on baseline halimeter scores, age, and gender. Test products were used three times a day. Breath measurements were taken 24 hours after baseline (after three product uses). Subjects then brushed again with the product treatment. Final breath measurements were taken 4 hours later, 28 hours after baseline. A 5-day washout separated each treatment period.

RESULTS

33 subjects were enrolled and completed the study. The adjusted mean volatile sulfur compound (VSC) levels were significantly lower in the SnF2 groups than the NaF groups, at both 24 (P < 0.01) and 28 (P < 0.001) hours post baseline time points. Tongue brushing did not provide additional statistically significant breath benefits when compared to toothbrushing alone. Both dentifrices were well tolerated.