The Oral-Malodor Reduction Efficacy of a 0.454% Stannous Fluoride Dentifrice

Objectives: To compare the oral malodor protection efficacy of a 0.454% stannous fluoride dentifrice versus a negative control (0.243% sodium fluoride) using Halimeter as the measurement.

Methods: This is a 4 treatment, 5 periods, examiner-blinded, cross-over and randomized study design. Healthy subjects who met the entrance criteria were enrolled into the study. After baseline halimeter measurement, subjects were randomly assigned to one of the 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 measurement was taken 24 hours after baseline the next day morning, followed by a product treatment. Final breath measurement was taken four hours post-treatment that was 28 hours after baseline.

Results: Thirty-three 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.

Conclusions: The present study demonstrated the safety and effectiveness of the 0.454% stannous fluoride dentifrice in the malodor control relative to a negative control.