IADR Abstract Archives
Three-Week Clinical Efficacy of Chlorine Dioxide-Containing Mouthrinse on Oral Malodor
Objectives: This three-week study assessed the safety and efficacy of a 0.1% stabilized chlorine dioxide-containing mouthrinse compared to a negative control in reducing/controlling intrinsic oral malodor.
Methods: Following IRB review and informed consent, subjects were screened for the parallel, two-treatment, randomized, double-blind, controlled clinical trial. The study was designed according to ADA Guidelines for Products Used in Management of Oral Malodor. A 0-5 Odor Intensity (OI) scale, as described by Rosenberg and McCulloch (1992), was used to evaluate reduction/control of intrinsic oral malodor of TheraBreath® Fresh Breath Oral Rinse (TBFB) compared to a negative control rinse (NC). Following a one-week acclimation period, subjects brushed twice daily in their usual manner with a soft toothbrush and ADA-Accepted fluoride toothpaste, rinsed one minute and gargled 30 seconds with their randomly assigned mouthrinse: TBFB or NC. Subjects received OI assessment of overnight breath odor (≥ 12 hours after home care regimen) by 4 odor judges at Baseline, 5 minutes after supervised use of home care regimen, and at Days 7 and 21. The 4 odor judges were blind to treatment assignments and independently assessed odor. Independent t-tests were used for between-group comparisons, two-sided at α=0.05.
Results: Sixty-five subjects completed the study. There were two treatment-related adverse events (taste alteration) during the study which were mild and resolved after one day. Relative to Baseline, both groups provided significant reduction in breath odor at 5 minutes, Day 7 and 21 post-product uses. Compared to the NC group, there were no significant differences at 5 minutes and Day 7 post-product use. At Day 21, the TBFB group showed significantly greater reduction in OI scores, 20.1% (p=0.042).
Conclusions: Twice daily rinsing with TheraBreath Fresh Breath oral rinse following standard oral hygiene was shown to be safe and effective against intrinsic oral malodor over 3 weeks.
Methods: Following IRB review and informed consent, subjects were screened for the parallel, two-treatment, randomized, double-blind, controlled clinical trial. The study was designed according to ADA Guidelines for Products Used in Management of Oral Malodor. A 0-5 Odor Intensity (OI) scale, as described by Rosenberg and McCulloch (1992), was used to evaluate reduction/control of intrinsic oral malodor of TheraBreath® Fresh Breath Oral Rinse (TBFB) compared to a negative control rinse (NC). Following a one-week acclimation period, subjects brushed twice daily in their usual manner with a soft toothbrush and ADA-Accepted fluoride toothpaste, rinsed one minute and gargled 30 seconds with their randomly assigned mouthrinse: TBFB or NC. Subjects received OI assessment of overnight breath odor (≥ 12 hours after home care regimen) by 4 odor judges at Baseline, 5 minutes after supervised use of home care regimen, and at Days 7 and 21. The 4 odor judges were blind to treatment assignments and independently assessed odor. Independent t-tests were used for between-group comparisons, two-sided at α=0.05.
Results: Sixty-five subjects completed the study. There were two treatment-related adverse events (taste alteration) during the study which were mild and resolved after one day. Relative to Baseline, both groups provided significant reduction in breath odor at 5 minutes, Day 7 and 21 post-product uses. Compared to the NC group, there were no significant differences at 5 minutes and Day 7 post-product use. At Day 21, the TBFB group showed significantly greater reduction in OI scores, 20.1% (p=0.042).
Conclusions: Twice daily rinsing with TheraBreath Fresh Breath oral rinse following standard oral hygiene was shown to be safe and effective against intrinsic oral malodor over 3 weeks.