Prevention of Dental Caries Lesions With Fluoride Varnish in Erupting First Permanent Molars

Phase 4

Completed

• Conditions: Dental Caries
• Interventions: Drug: Fluoride Varnish; Drug: Control Group

• Registration Number: NCT02592278
• Lead Sponsor: Universidad Iberoamericana

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-10-28
• Study First Submitted QC: 2015-10-28
• Study First Posted: 2015-10-30
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-02
• Last Update Posted: 2016-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluoride Varnish each 3 months	Fluoride Varnish	Fluoride Varnish application every 3 months.
Fluoride Varnish each 6 months	Fluoride Varnish	Fluoride Varnish application every 6 months.
Fluoride tooth paste	Control Group	Control group. Twice a day brush with fluoride toothpaste.

Primary Outcome Measures

Name	Time	Method
Number of first permanent molars with caries Lesion (taking into account ICDAS criteria)	One year	We are going to measure changed to decay surfaces in first permanent molars = ICDAS \> 0 in a year.