To evaluate the effectiveness and acceptability of the fluoridated toothpaste to prevent plaque and gum diseases in children in the age group of 6 to 12 years
Phase 3
- Registration Number
- CTRI/2024/02/062692
- Lead Sponsor
- Avoden pvt ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Subjects with plaque score 1
Subjects with gingival scores 1 and 2
Subjects showing signs of mild marginal gingival inflammation
Subjects parent or guardian who agree to comply with all study requirements and are able to follow the study directions.
Exclusion Criteria
gingival scores more than 2
orthodontic bands and five or more carious lesions
History of allergies
Subject on antibiotics
Subject with five or more carious lesions requiring immediate restorative treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in the plaque and gingival scores <br/ ><br> <br/ ><br>Changes in the clinical signs of gingival inflammation <br/ ><br> <br/ ><br> <br/ ><br>Changes in the clinical signs of gingival inflammation <br/ ><br> <br/ ><br>Timepoint: Plaque and gingival score to be assessed at 1 monthi.e at 1st followup 2 months i.e at2nd followup and 3 months i.e at 3rd followup
- Secondary Outcome Measures
Name Time Method nderstanding products acceptability through survey data pointsTimepoint: acceptability and tolerability to be assessed after 1 month