A clinical validation of Zugu Oral Rinse Liquid Toothpaste for antiplaque and antigingivitis potential, as an alternative to conventional toothpaste. - Nil

Ruba Ventures Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年8月21日

试验速览

暂无简介。

•1) Age: 18 to 55 years (both inclusive) at the time of consent.2) Sex: Healthy male and non-pregnant/non-lactating females.3) Females of childbearing potential must have a negative urine pregnancy test performed on screening.4) Subjects are in good general health as determined by the Investigator on the basis of medical history.5) Subjects having clinically relevant mouth malodor evident by Halimeter.6) Subjects with mild and moderate plaque with plaque index 2-4.7) Subjects with mild to moderate gingivitis with modified gingival index 0.1-2.0.8) Subjects should be willing to come to the study site without brushing their teeth in the morning for visit 1, visit 2, and visit 3.9) Subject willing to stay at study center for 6 hrs on visit 1, visit 2, and visit 3.10) Subjects should be willing to not consume anything except water after the meal of previous night.11) Subjects must be able to understand and provide written informed consent to participate in the study.12) Subjects should be willing and able to follow the study directions to participate in the study.

•1) Subjects with orthodontic bands.
•2) Subjects with plaque index of 0, 1 and 5
•3) Subjects with partial removable dentures.
•4) Subjects having tumor(s) of the soft or hard tissues of the oral cavity.
•5) Subjects with advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone)
•6) Subjects with a history of drug-induced tooth discoloration.
•7) Subjects having carious lesion which requires immediate restorative treatment.
•8) Subjects with ongoing antibiotic treatment at the time of screening.
•9) Subjects having participated in any other dental clinical study
•within the last six months prior to entry into the study.
•10) Subjects with dental prophylaxis during the past two weeks prior to baseline examinations.
•11) Subjects with a history of allergies to any oral care/personal care consumer products or their ingredients.
•12) Subjects on any prescription medicines that might interfere with the study outcome.
•13) Pregnant and lactating women.
•14) Subjects habitual to consumption of any medicated sweets, chewing gum, breath fresheners, etc. containing antimicrobial agents.
•15) Subjects with diseases or having a history that potentially can contribute to oral malodor (e.g. diabetes mellitus, bronchitis, tonsillitis, sinusitis etc.)
•16) Subjects habitual of consumption of alcohol, tobacco, and smoking cigarettes.

发起方

Ruba Ventures Private Limited