CTRI/2024/03/064553
Not yet recruiting
Phase 2/3
Comparative evaluation of Remineralizing Potential of Acidified Caesin Phosphopeptide Amorphous Calcium Phosphate Fluoride and Acidulated Phosphate Fluoride on early enamel carious lesion -A Randomized Controlled Trial
Dr Sasidharan S1 site in 1 country300 target enrollmentStarted: April 15, 2024Last updated:
Overview
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Dr Sasidharan S
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Reversal of early enamel lesion evaluated through ICDAS scores
Overview
Brief Summary
The early carious lesions categorized with ICDAS scores 1 & 2 in the dentition of 6 years and above age group children will be recruited and one group will be treated with Acidified CPP-ACPF gel (study group) and the other with conventional APF gel (comparator group). Upon 6th month and 1 year of observation, the early carious lesion reversal is observed and recorded to see the remineralisation efficiency of the test and control agents.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 6.00 Year(s) to 12.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Subjects with ICDAS II code 1
- •Those who have high caries prevalence experience.
Exclusion Criteria
- •Those with systemic disease
- •Those with special care needs children.
- •Caries with ICDAS II code more than
- •Those who don’t give consent to participate.
Outcomes
Primary Outcomes
Reversal of early enamel lesion evaluated through ICDAS scores
Time Frame: Reversal of early enamel lesion evaluated through ICDAS scores at month 6 and 12
Secondary Outcomes
- DMFS(6 and 12 month)
Investigators
Rahmath Meeral P
Saveetha Dental College and Hospital
Study Sites (1)
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