To evaluate the efficacy and acceptability of the fluoridated toothpaste in its anti-plaque and anti-gingivitis properties in a pediatric population in the age group of 6 to 12 years – A non- randomized active controlled clinical trial.
Overview
- Phase
- Phase 3 4
- Status
- Not yet recruiting
- Sponsor
- Avoden pvt ltd
- Enrollment
- 300
- Locations
- 5
- Primary Endpoint
- Changes in the plaque and gingival scores
Overview
Brief Summary
T The study is a randomized controlled trial to check for the efficacy and acceptability of fluoridated toothpaste in a pediatric population. This study will be conducted across five centers in India with a total sample size of 300 pediatric patients. The primary outcome of the study is changes in the plaque and gingival scores and changes in the clinical signs of gingival inflammation. The secondary outcome is understanding products acceptability and tolerability through survey data points
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 6.00 Year(s) to 12.00 Year(s) (—)
- Sex
- All
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.
Outcomes
Primary Outcomes
Changes in the plaque and gingival scores
Time Frame: 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
Changes in the clinical signs of gingival inflammation
Time Frame: 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 Outcomes
- Understanding products acceptability through survey data points(acceptability and tolerability to be assessed after 1 month)
Investigators
Dr Ashok Dhoble
Indian Dental Association