A crossover, randomized, double-blind, two-arm, placebo-controlled, clinical study to evaluate the efficacy of SBO-635 in halitosis and oral microbiota modulation in healthy adult subjects with halimeter score above 200

Innovation Labo Research0 个研究点目标入组 42 人开始时间: 2023年2月1日最近更新: 2023年2月13日

研究概览

暂无简介。

•1. Non-smoking healthy subjects between 21 to 55 years (inclusive) of age
•2. Subjects with conformed halitosis (Organoleptic score =2 and Halimeter score =180)
•3. Subjects who are free from any active oral infections or inflammatory conditions such as dental caries, mouth ulcers, gingivitis or periodontitis
•4. Subjects willing to give written informed consent and willing to comply with the trial protocol
•5. Subjects willing to adhere to a standard oral care protocol during the study period
•6. Subjects willing to refrain from using alcohol during the study period
•7. Subjects who are able to understand the risks/benefits of the protocol
•8. Subject should be available for the duration of the study period (6 weeks)

•1. Subjects with a history of oral malignancy
•2. Subjects with possible extra oral causes for halitosis: laryngopharyngeal reflux, tonsillitis, sinusitis, metabolic acidosis or alkalosis, renal diseases, liver malfunctions, dental brackets or bridges, dental infections and diabetes mellitus
•3. Pregnant or lactating females
•4. Subjects who have used oral antibiotics, non-steroid anti-inflammatory drugs (NSAIDs) corticosteroids or nutrition supplements within 3 months from the start of the study
•5. Subjects who are participating or have participated in any other clinical trial within 3 months from the start of the study
•6. Subjects with a history of psychiatric disorder that may impair the ability of subjects to provide written informed consent
•7. Drug or alcohol abusers
•8. Any other condition that the Principal Investigator thinks may jeopardize the study outcome

发起方

Innovation Labo Research