An Open label Study to Evaluate the Efficacy and Safety of LPOTC001-11 versus Colgate Plax in dental plaques and gingivitis

aila Pharmaceuticals Pvt Ltd0 个研究点目标入组 40 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Both male and female subjects in the age group of 18 â?? 65
•Subject should have gingivitis (i.e., have pocket depths of 2-3 mm or less), but not periodontitis
•Subject with a mean plaque index (PI) (Turesky modification of the Quigley Hein Plaque Index, 1970) of at least 1.5 or more
•Subject with a mean gingival index (GI) (Loe and Silness in 1963 and modified in 1967) of at least 1.0 or more
•Subject should have a minimum of 20 natural teeth, including 4 molars
•Women with child-bearing potential & planning a pregnancy should be excluded or if otherwise, willing to adopt effective and approved birth control regimen for the entire trial duration (oral contraceptive, intrauterine device, barrier plus spermicide).
•Subjects willing to floss twice every day and have the necessary dexterity to floss

•Female Subject who are pregnant or lactating
•Subject with active carious lesions and orthodontic braces
•Subject with more than 2 crowns or bridges and more than 2 implants.
•Subject with full or partial dentures.
•Subject with periodontitis, i.e., pocket depths of 5 mm or more in more than 2 sites in the mouth
•Subject who had undergone scaling 30 days prior to screening.
•History of periodontal treatment within the last month.
•History of or current alcohol abuse that, in the opinion of the Investigator, could influence the outcome of the study.
•History of or current drug abuse.
•Use of concomitant medication that, in the opinion of the Investigator, might interfere with the outcome of the study (e.g. antibiotics, immuno-suppressants, steroids, or therapeutic doses of non-steroidal anti-inflammatory agents, phenytoin, calcium antagonists, cyclosporine or coumadin).
•Use of any antimicrobial mouth rinse within the last month.
•Participation in another trial within one month prior to the study.
•Inability to comply with the trial protocol by not rinsing with mouth rinse 20% of time.
•Known liver, kidney, cardiovascular, neurologic, or pulmonary disease; treated or untreated hypertension.
•Known hypersensitivity to curcuminoid.
•Require pre-medication with antibiotics for dental treatment.
•Cigarette-smoking or use of tobacco products

发起方

aila Pharmaceuticals Pvt Ltd