Randomized Clinical Trial to Validate Organoleptic Judges

Objectives: The objective of the study was to validate organoleptic judges by evaluating the effectiveness of a marketed antiseptic mouthrinse to reduce oral malodor relative to a distilled water control.
Methods: This was a randomized, two treatment group cross-over clinical trial to compare organoleptic judges using the odor intensity (OI) index after a 30 second treatment with Listerine Cool Mint Antiseptic Mouthwash relative to a distilled water control. Generally healthy and consented volunteers who fulfilled all inclusion/exclusion criteria with an average Halimeter reading ≥ 100 ppb volatile sulfur compounds (VSC) were enrolled in the study. Subjects with a baseline morning breathe OI score >2 by each organoleptic judge were randomized and supervised with their first dose. Judges performed OI evaluations at 30, 60, 90 and 120 minutes after the 30 second rinse. Wilcoxon’s Signed Rank Tests were used for both within- and between-treatment analyses comparing changes from baseline. Analysis of Covariance (ANCOVA) was also utilized to compare the 8-judge average differences at each post-treatment time point using judges’ average baseline as the covariate. All Statistical tests were two-tailed and employed a 0.05 level of significance.
Results: All 19 subjects who were randomized to treatment completed the study. The Signed Rank test and ANCOVA analysis resulted in highly statistically significant (p<0.0001) differences between treatments at each post-treatment time point.
Conclusions: The organoleptic judge validation exercise using the OI index resulted in excellent differentiation between products over sequential evaluation periods.