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

NCT ID: NCT02592278

Last Updated: 2016-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-03-31

Brief Summary

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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

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Conditions

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Dental Caries

Keywords

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Dental Caries Fluoride Varnish Preschool child Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Fluoride Varnish each 6 months

Fluoride Varnish application every 6 months.

Group Type EXPERIMENTAL

Fluoride Varnish

Intervention Type DRUG

Application of fluoride varnish every 3 and 6 months.

Fluoride Varnish each 3 months

Fluoride Varnish application every 3 months.

Group Type EXPERIMENTAL

Fluoride Varnish

Intervention Type DRUG

Application of fluoride varnish every 3 and 6 months.

Fluoride tooth paste

Control group. Twice a day brush with fluoride toothpaste.

Group Type ACTIVE_COMPARATOR

Control Group

Intervention Type DRUG

Twice a day brush with fluoride toothpaste.

Interventions

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Fluoride Varnish

Application of fluoride varnish every 3 and 6 months.

Intervention Type DRUG

Control Group

Twice a day brush with fluoride toothpaste.

Intervention Type DRUG

Other Intervention Names

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Duraphat (Colgate) Colgate Total Toothpaste

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Colgate Palmolive

INDUSTRY

Sponsor Role collaborator

Universidad Iberoamericana

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ninoska Abreu

Role: PRINCIPAL_INVESTIGATOR

Universidad Iberoamericana

Other Identifiers

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04-2015

Identifier Type: -

Identifier Source: org_study_id