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

November 2, 2016 updated by: Universidad Iberoamericana

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 7 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fluoride Varnish each 6 months
Fluoride Varnish application every 6 months.
Drug: Fluoride Varnish
Application of fluoride varnish every 3 and 6 months.
Other Names:
  • Duraphat (Colgate)
Experimental: Fluoride Varnish each 3 months
Fluoride Varnish application every 3 months.
Drug: Fluoride Varnish
Application of fluoride varnish every 3 and 6 months.
Other Names:
  • Duraphat (Colgate)
Active Comparator: Fluoride tooth paste
Control group. Twice a day brush with fluoride toothpaste.
Drug: Control Group
Twice a day brush with fluoride toothpaste.
Other Names:
  • Colgate Total Toothpaste

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Iberoamericana

Collaborators

Colgate Palmolive

Investigators

  • Principal Investigator: Ninoska Abreu, Universidad Iberoamericana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

October 28, 2015

First Submitted That Met QC Criteria

October 28, 2015

First Posted (Estimate)

October 30, 2015

Study Record Updates

Last Update Posted (Estimate)

November 4, 2016

Last Update Submitted That Met QC Criteria

November 2, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dental Caries

Clinical Trials on Fluoride Varnish

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe