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Completed

NCT Number: NCT02592278

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

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).

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

6 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluoride varnish

Drug

Application of fluoride varnish every 3 and 6 months.

Other names: Duraphat (Colgate)

Control group

Drug

Twice a day brush with fluoride toothpaste.

Other names: Colgate Total Toothpaste

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Universidad Iberoamericana

Other

Collaborators

  • Colgate Palmolive

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 30, 2015
Registry last updated
Nov 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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