A clinical trial to assess the Efficacy and Safety of LPOTC001-11 versus Colgate Plax in dental plaques and gingivitis
- Conditions
- Health Condition 1: null- Gingivitis (i.e., have pocket depths of 2-3 mm or less), but not periodontitis
- Registration Number
- CTRI/2012/02/002460
- Lead Sponsor
- aila Pharmaceuticals Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
• 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method