Controlling Oral Malodor Following Two-Weeks Use of a Fluoride Mouthrinse

Objectives: The purpose of this two-week clinical trial was to determine the degree and duration of effectiveness of two LISTERINE® SMART RINSE™ flavors (MINT SHIELD® and BERRY SHIELD™), anticavity fluoride (0.022% NaF) mouthrinse, compared to toothbrushing alone in reducing and controlling human intrinsic oral malodor using hedonic methodology. Methods: Upon IRB approval of this observer-blind, two-week, parallel group, controlled clinical study, qualified subjects with hedonic scores above the threshold value for unpleasant breath were randomized into one of two LISTERINE® SMART RINSE™ fluoride mouthrinses or toothbrushing alone (negative control). All subjects brushed with fluoride toothpaste for one minute and rinsed with water. Subjects assigned to the LISTERINE® SMART RINSE™ anticavity fluoride mouthrinses rinsed with 10 mL, 60 seconds. Following the supervised regimen, subjects were assessed for post-treatment hedonic ratings by five trained judges at 15, 30, 60, 90 and 120 minutes. The hedonic malodor evaluations were performed utilizing a nine point hedonic scale. Subjects followed their assigned treatment regimen twice daily for 14 consecutive days. At Day 14, oral malodor assessments were repeated. Data were analyzed using a step-wise procedure starting with a joint evaluation of the mean malodor ratings with testing post-rinse at 15 minutes, 30-60 minutes and 90-120 minutes. Evaluation of the 15 minutes post-rinse assessment was based on an ANCOVA and joint evaluations involving more than one assessment time point (30-60 and 90-120 post-rinse) were based on a repeated-measures ANCOVA. Results: 131 subjects completed the study. On Day 14, the two fluoride mouthrinse were statistically significant at all time points (15, 30, 60, 90 and 120 minutes) in reducing and controlling oral malodor as compared to brushing alone (p<0.05). Conclusion: Beyond brushing alone, the two LISTERINE® SMART RINSE™ anticavity fluoride mouthrinses effectively reduced and controlled intrinsic oral malodor using hedonic methodology in a two-week clinical trial.