MedTrace Logo

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

NCT02592278 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2016-11-04

No results posted yet for this study

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).

Conditions

  • Dental Caries

Interventions

DRUG

Fluoride Varnish

Application of fluoride varnish every 3 and 6 months.

DRUG

Control Group

Twice a day brush with fluoride toothpaste.

Sponsors & Collaborators

  • Colgate Palmolive

    collaborator INDUSTRY

  • Universidad Iberoamericana

    lead OTHER

Principal Investigators

  • Ninoska Abreu · Universidad Iberoamericana

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2016-03-31
Completion
2016-03-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02592278 on ClinicalTrials.gov