SLS Clinical Research Consulting, Warrington, PA, United States of America.
Novonesis, Berlin, Germany.
J Breath Res. 2024 Nov 25;19(1). doi: 10.1088/1752-7163/ad8e7c.
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 OralChromareading of ⩾125 parts per billion (ppb) hydrogen sulfide (HS) 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 OralChromameasurement 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 (< 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 (< 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.
口腔异味会降低人的生活质量，受其影响的人群可能高达 50%。本项随机、安慰剂对照、观察者设盲、概念验证研究的目的是评估单次使用两种含漆酶和绿咖啡提取物（含或不含调味剂）的实验锭剂在降低内源性口腔异味方面的有效性和安全性。在避免口腔卫生 12-16 小时后，156 名一般健康受试者在筛选和基线就诊时的平均感官气味强度（OI）评分为 ⩾2，且 OralChrom读数 ⩾125 十亿分之几（ppb）的硫化氢（HS）气体，并随机分配接受两种实验锭剂之一、安慰剂锭剂或无产品。在监督使用指定产品后，立即在使用产品后（约 5 分钟）以及使用后 30 分钟、1 小时、2 小时、3 小时和 4 小时使用 OI 评估和 OralChrom 测量评估受试者的口腔异味，用于挥发性硫化合物（VSCs）。与安慰剂和无产品组相比，含和不含调味剂的两种实验锭剂在所有时间点（<0.001）的 OI 评分均显著降低。在产品使用后 5 分钟时，含和不含调味剂的实验锭剂在降低 VSCs 方面明显优于无产品组（<0.04）。个别 VSC 成分（硫化氢、甲硫醇和二甲硫醚）的结果各不相同；两种实验锭剂在大多数使用后评估中均显著降低了硫化氢和甲硫醇水平。报告了 4 例轻微不良事件，均与产品无关。总之，基于感官 OI 评分，含或不含调味剂的实验锭剂在 4 小时内安全有效，可降低口腔异味。临床试验编号：NCT05950529。
