Oral Malodor Reduction/Control of Chlorine Dioxide-Containing Mouthrinse in Three-Week Study

Objectives: This three-week, parallel, two-treatment, randomized, double-blind, controlled study assessed the safety and efficacy of a chlorine dioxide-containing mouthrinse, compared to negative control, in reducing/controlling intrinsic oral malodor.

Methods: The study was designed according to ADA Guidelines for Products Used for Oral Malodor Management. Following IRB approval and informed consent, 64 subjects qualified with organoleptic score ≥2 using 0-5 Odor Intensity (OI) scale, (Rosenberg, McCulloch, 1992). Following one-week acclimation period of normal homecare, subjects were randomly assigned to TheraBreath^® Fresh Breath Oral Rinse (TBFB) or negative control rinse (NC). Subjects brushed twice daily in their usual manner with soft toothbrush and fluoride toothpaste, rinsed one minute and gargled 30 seconds with their randomly assigned mouthrinse: TBFB or NC. Overnight breath odor (≥ 12 hours after brush/rinse regimen) was assessed using OI (4 odor judges) and VSC/Halimeter levels at Baseline/Day 1, Day 7 and Day 21. Immediate effect of brushing and rinsing was assessed using OI at 5 minutes post-supervised use of products. The primary efficacy variable was the mean change in OI Scores from Baseline at Day 21.
Results: 64 subjects completed the study. There were few minor adverse events (dry mouth/taste change) that were related to both rinses. Relative to Baseline, both groups significantly reduced OI scores at 5 minutes, Days 7 and 21 as well as VSC levels at Days 7 and 21, p<0.0001. Compared to NC, there were no significant differences for OI at 5-minute timepoint and no differences in VSCs at Days 7 and 21. After 7 and 21 days, TBFB group showed significantly greater reduction in OI scores, 80.3% and 77.9%, respectively (p<0.0001).
Conclusions: These results demonstrate that TheraBreath^® Fresh Breath oral rinse is safe and effective against intrinsic oral malodor over 3 weeks when used in conjunction with standard oral hygiene.