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.

Efficacy of stabilized chlorine dioxide-based unflavored mouthwash in reducing oral malodor: An 8-week randomized controlled study.

PURPOSE: To evaluate the efficacy of a mouthwash containing stabilized chlorine dioxide in reducing oral malodor when used as an adjunct to tooth brushing compared with the use of a placebo mouthwash. METHODS: This 8-week study in healthy subjects with clinically diagnosed intrinsic oral malodor was a 2-way crossover, double-blind, randomized, and controlled trial design, which was conducted at a single site. Subjects were randomized to receive either unflavored, non-fluoridated, and alcohol-free mouthwash containing 0.1% stabilized chlorine dioxide or a placebo mouthwash with identical bottle packaging. Both groups were provided with the same toothpaste and toothbrush. Subjects consented to the 8-week participation and were instructed to use their allocated treatment twice daily. In Phase I, quantified odor intensity [measured by an organoleptic intensity rating scale of 0-5, with 0=malodor cannot be detected and 5=very strong malodor] was independently evaluated by three calibrated judges at baseline, and after 1, 2, and 3 weeks of treatment. Following a 2-week washout period, Phase II initiated with the redistribution of test products. The subjects' organoleptic scores were assessed by the calibrated judges at baseline, and 6, 7, and 8 weeks of treatment. RESULTS: A total of 50 subjects were enrolled and randomized into the two groups. Of these, 47 subjects completed the study. The baseline organoleptic intensity scores for both groups during Phase I and Phase II were not significantly different (P= 0.224, P= 0.071, respectively). At all visits, the organoleptic scores for the placebo rinse group during both Phase I and Phase II were not significantly different. During Phase I, the mean of individual organoleptic change scores from the stabilized chlorine dioxide rinse group were significantly different from the baseline at the last two follow-up visits:Week 1 (P= 0.088), Week 2 (P= 0.001), Week 3 (P= 0.1×10-3). During Phase II, the mean of individual organoleptic change scores from the stabilized chlorine dioxide rinse group were also significantly different from the baseline at the last two follow-up visits: Week 6 (P= 0.120), Week 7 (P= 0.004), Week 8 (P= 0.002). CLINICAL SIGNIFICANCE: The results of this study suggest the daily use of a stabilized chlorine dioxide-containing unflavored mouthwash as an adjunct to brushing with fluoride toothpaste provides a clinically relevant reduction in oral malodor after 3 weeks of twice-daily use.