Health Condition 1: null- Gingivitis (i.e., have pocket depths of 2-3 mm or less), but not periodontitis
Conditions
Interventions
Intervention1: LPOTC001-11: 15ml twice daily for 14 days
Control Intervention1: Colgate Plax: 15ml twice daily for 14 days
Sponsors
Laila Pharmaceuticals Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ Change in gingival Index from baseline to Day 7 and Day 14.Timepoint: Day 0, Day 7 and Day 14. | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Change from baseline to day 7 and day 14 in reduction of microorganism from Plaque using PCR analysisTimepoint: Day 0, Day 7 and Day 14;â?¢ Change in bad breath from baseline to day 7 and day 14 with an organoleptic scale ranging from 0 to 5Timepoint: Day 0, Day 7 and Day 14;â?¢ Change in Plaque Index from baseline to Day 7 and Day 14Timepoint: Day 0, Day 7 and Day 14;â?¢ Physicianâ??s global evaluation at week 1 and week 2 of treatmentTimepoint: Day 7 and Day 14;â?¢ Proportion of reduction in Plaque Index and Gingival index from baseline to day 7 and day 14Timepoint: Day 7 and Day 14 | — |
Countries
India
Contacts
Public ContactMr Sanjib Kumar Panda
Laila Pharmaceuticals Pvt. Ltd.,
Outcome results
None listed