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

Universidad Iberoamericana

Status and phase: Completed; Phase 4

Conditions: Dental Caries

Treatments: Drug: Control Group; Drug: Fluoride Varnish

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02592278

04-2015

Details and patient eligibility

About

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).

Enrollment: 180 patients

Sex: All

Ages: 6 to 7 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 3 patient groups

Fluoride Varnish each 6 months

Experimental group

Description:

Fluoride Varnish application every 6 months.

Treatment:

Drug: Fluoride Varnish

Fluoride Varnish each 3 months

Experimental group

Description:

Fluoride Varnish application every 3 months.

Treatment:

Drug: Fluoride Varnish

Fluoride tooth paste

Active Comparator group

Description:

Control group. Twice a day brush with fluoride toothpaste.

Treatment:

Drug: Control Group