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

Abstract

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.