A randomized, blinded, clinical investigation of breath odor reduction efficacy of a stabilized chlorine-dioxide containing flavored mouthwash.

PURPOSE

To evaluate the efficacy of a flavored, non-fluoridated, alcohol-free mouthwash containing 0.1% chlorine dioxide in reducing oral malodor.

METHODS

This was a randomized, 8-week, single site, double blind, crossover design with a 2-week washout period between crossover phases. Fifty subjects with clinically diagnosed intrinsic oral malodor were enrolled according to inclusion/exclusion criteria and randomized to one of two groups. Washout period initiated at end of Phase I and crossover design implemented prior to Phase II. Calibration for organoleptic judges performed at baseline for both phases.

RESULTS

48 subjects completed the study. No significant differences in intensity scores at baseline were found for both groups during both phases (P> 0.05). Within group comparisons for placebo revealed no significant differences with organoleptic intensity scores for all visits during both phases (P> 0.05). During Phase I, the mean changes in organoleptic scores for the test group were significantly different from the baseline at each visit: Weeks 1 to 3 (P< 0.05). After crossover, significant differences were found for the last two visits: Weeks 7 and 8 (P< 0.05). No adverse effects to oral tissues were observed or reported. This product is safe to use for up to 3 weeks and resulted in a decrease in oral malodor.

CLINICAL SIGNIFICANCE

Results suggested that twice-daily use of a 0.1% chlorine dioxide-containing flavored mouthwash, in conjunction with normal oral hygiene care, provided clinically relevant improvements in oral malodor for up to 3 weeks.