An Open label, Clinical Study to Evaluate the Oral Mucosal Safety & Efficacy of HDNT-072012 in Healthy Adult Subjects

Himalaya Wellness Company0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年2月21日

试验速览

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•1.Subjects with age group 18 years to 60 years in general good health and oral health.
•2.Subjects willing to provide consent to the study
•3.Subjects with moderate oral hygiene and adhering to basic habits like using standard toothbrush and toothpaste
•4.No history of any clinically significant medical condition
•5.No recent history (past 3 months) of overall oral/gum bleeding disorders
•6.No history of any medical problems requiring hospital care.
•7.Willing to abide by and comply with the study protocol.
•8.Available to comply the study procedure for the entire duration of the study.
•9.Should not have participated in a similar clinical study in the past four weeks and who are willing not to participate in any other clinical study during participation in the current study.

•1.A known history or present condition of hyper sensitivity to any test product.
•2.No oral substance abuse such as current use or recent history of tobacco, pan, gutka, cigarette
•3.Pregnant and lactating subjects
•4.The use of antibiotic, antimicrobial, analgesic medications, desensitizing test product during the previous 1 month.
•5.Any history of periodontal therapy by surgical interventions.
•6.Any history of dentine hypersensitivity treatment.
•7.Any removable device such as a removable partial denture or orthodontic retainer.
•8.The presence of any large or defective restorations, cracked enamel, or caries on the History hypersensitive tooth.
•9.Having intrinsic dental stains.
•10.Having abnormal frenum attachment.
•11.Having moderate to severe level of calculus and/ tartar.
•12.Any underlying uncontrolled medical illness including diabetes mellitus, hypertension, liver disease or history of currently using any medication or expects to be on any medication which in the opinion of the investigator, may affect the evaluation of the test product, or place the subject at undue risk.
•13.Suffering from any form of systemic illness, oral infections, hospitalizations and pharmacological treatment.

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