CTRI/2025/09/095106
Not yet recruiting
Phase 3
Clinical research study to evaluate the efficacy of a stannous fluoride toothpaste on established dental plaque and gingivitis in adults
Colgate-Palmolive Company1 site in 1 country100 target enrollmentStarted: September 29, 2025Last updated:
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Colgate-Palmolive Company
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Gingivitis (Loe and Silness Index)
Overview
Brief Summary
The objective of this clinical research study is to evaluate the efficacy of a specialized toothpaste on established dental plaque and gingivitis in adults. This is a phase III, single center, randomized, parallel and double blinded study conducted on about 100 subjects in the age group between 18 to 70 years.
The subjects will be exposed to either of 2 different test products for a period of 6 months with a treatment regimen of whole mouth brushing twice daily for 2 minutes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Potential subjects must meet ALL of the following criteria: Males and females, between 18-70 years of age; Informed Consent Form signed and availability for the duration of the study; Good general health (absence of any condition that, in the opinion of the Principal Investigator, might constitute a risk to the subject while participating in the study.
- •Examples include heart problems, valve/hip replacements, etc); Willingness to provide information related to their medical history; Minimum of 15 uncrowned permanent natural teeth (excluding third molars); Initial mean gingivitis index of at least 1 as determined by the use of the Loe and Silness Gingival Index and mean Plaque Index score of at least 1.5 determined by the Turesky modification of the Quigley-Hein Plaque Index; Availability for the duration of the study.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Gingivitis (Loe and Silness Index)
Time Frame: Baseline, 3 months and 6 months
Secondary Outcomes
- Plaque (Turesky modification of the Quigley-Hein Plaque Index)(Baseline, 3 months and 6 months)
Investigators
Dr Ashish Kakar
GLOBAL HEALTH RESERCH GROUP
Study Sites (1)
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