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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02592278

Enrollment

180

Registered

2015-10-30

Start date

2015-03-31

Completion date

2016-03-31

Last updated

2016-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries

Keywords

Dental Caries, Fluoride Varnish, Preschool child, Prevention

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).

Interventions

DRUGFluoride Varnish

Application of fluoride varnish every 3 and 6 months.

DRUGControl Group

Twice a day brush with fluoride toothpaste.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

6 Years to 7 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026