Oral malodor negatively impacts a person's quality of life and may affect up to 50% of the population. The aim of this randomized, placebo and no-product controlled, evaluator-blind, proof-of-concept study was to evaluate the effectiveness and safety of the single use of two experimental lozenges containing the laccase enzyme and green coffee extract (with and without flavor) in reducing intrinsic oral malodor. Following 12-16 h of avoidance of oral hygiene,156 generally healthy subjects presented at screening and baseline visits with a mean organoleptic odor intensity (OI) score of ⩾2 and an OralChromaTMreading of ⩾125 parts per billion (ppb) hydrogen sulfide (H2S) gas and were randomly assigned to receive either one of the two experimental lozenges, a placebo lozenge, or no-product. Following the supervised use of the assigned products, subjects' oral malodor was evaluated using OI assessments and OralChromaTMmeasurement for volatile sulfur compounds (VSCs) immediately following product use (approximately 5 min), and at 30 min, 1 h, 2 h, 3 h and 4 h. The two experimental lozenges, with and without flavor, showed significant reductions in OI scores compared with the placebo and no-product groups at all time points (p< 0.001). At 5 min post-product use, the experimental lozenges, with and without flavor, were significantly better than the no-product group in reducing the VSCs (p< 0.04). The results of individual VSC components (hydrogen sulfide, methyl mercaptan and dimethyl sulfide) were variable; both experimental lozenges notably reduced hydrogen sulfide and methyl mercaptan levels in most post-use assessments. Four minor adverse events were reported, none of which were directly linked to the product. In conclusion, the experimental lozenges, whether flavored or not, were safe and effective in reducing oral malodor over a span of 4 h, based on organoleptic OI scores.Clinical Trial No: NCT05950529.
Keywords: green coffee extract; halitosis; laccase enzyme; oral malodor; organoleptic assessment; volatile sulfur compounds.
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