Prevention of Dental Caries Lesions With Fluoride Varnish in Erupting First Permanent Molars
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Universidad Iberoamericana
- Enrollment
- 180
- Primary Endpoint
- Number of first permanent molars with caries Lesion (taking into account ICDAS criteria)
Study Overview
Brief Summary
The aim of this study is to determine the effectiveness of fluoride varnishes in the prevention of dental caries lesions in erupting permanent first molars, in high-risk patients. Using as reference ICDAS criteria, when the success means that the surface maintain an ICDAS value 0 and failure that has change in ICDAS value 0 to 1.
Sample: The sample comprise 180 patients between 6-7 years old with high-risk of dental caries.
Study design: It proposed an experimental design randomized into 3 groups according to the frequency of topical fluoride application.(Group A: every 6 month; Group B: every 3 month; Group C: positive control).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 6 Years to 7 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Informed Consent from parents.
- •Child assent
- •High risk of dental caries
- •At least one sound first permanent molar (ICDAS=0)
Exclusion Criteria
- •Bad behaviour
- •Any systemic condition, disability
Arms & Interventions
Fluoride Varnish each 6 months
Fluoride Varnish application every 6 months.
Intervention: Fluoride Varnish (Drug)
Fluoride Varnish each 3 months
Fluoride Varnish application every 3 months.
Intervention: Fluoride Varnish (Drug)
Fluoride tooth paste
Control group. Twice a day brush with fluoride toothpaste.
Intervention: Control Group (Drug)
Outcomes
Primary Outcomes
Number of first permanent molars with caries Lesion (taking into account ICDAS criteria)
Time Frame: One year
We are going to measure changed to decay surfaces in first permanent molars = ICDAS \> 0 in a year.
Secondary Outcomes
No secondary outcomes reported