This trial has been completed.

Condition dental caries
Treatments fluoride varnish, control group
Phase phase 4
Sponsor Universidad Iberoamericana
Collaborator Colgate Palmolive
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).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose prevention
Fluoride Varnish application every 6 months.
fluoride varnish Duraphat (Colgate)
Application of fluoride varnish every 3 and 6 months.
Fluoride Varnish application every 3 months.
fluoride varnish Duraphat (Colgate)
Application of fluoride varnish every 3 and 6 months.
(Active Comparator)
Control group. Twice a day brush with fluoride toothpaste.
control group Colgate Total Toothpaste
Twice a day brush with fluoride toothpaste.

Primary Outcomes

Number of first permanent molars with caries Lesion (taking into account ICDAS criteria)
time frame: One year

Eligibility Criteria

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

Additional Information

Official title Prevention of Dental Caries Lesions With Fluoride Varnish in Erupting First Permanent Molars
Principal investigator Ninoska Abreu
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Universidad Iberoamericana.