Prevention of Dental Caries Lesions With Fluoride Varnish in Erupting First Permanent Molars
This trial has been completed.
|Treatments||fluoride varnish, control group|
|Start date||March 2015|
|End date||March 2016|
|Trial size||180 participants|
|Trial identifier||NCT02592278, 04-2015|
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).
|Intervention model||parallel assignment|
|Masking||single blind (investigator)|
Number of first permanent molars with caries Lesion (taking into account ICDAS criteria)
time frame: One year
Male or female participants from 6 years up to 7 years old.
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
|Official title||Prevention of Dental Caries Lesions With Fluoride Varnish in Erupting First Permanent Molars|
|Principal investigator||Ninoska Abreu|
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