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

NCT02592278 | Completed Phase 4

• 1 other identifier: 04-2015
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Dental Caries; Fluoride Varnish; Preschool child; Prevention

Outcome Measures

Primary Outcomes (1)

• Number of first permanent molars with caries Lesion (taking into account ICDAS criteria)

  We are going to measure changed to decay surfaces in first permanent molars = ICDAS \> 0 in a year.

  One year

Study Arms (3)

Fluoride Varnish each 6 months

EXPERIMENTAL

Fluoride Varnish application every 6 months.

Drug: Fluoride Varnish

Fluoride Varnish each 3 months

EXPERIMENTAL

Fluoride Varnish application every 3 months.

Drug: Fluoride Varnish

Fluoride tooth paste

ACTIVE COMPARATOR

Control group. Twice a day brush with fluoride toothpaste.

Drug: Control Group

Interventions

Fluoride Varnish DRUG

Application of fluoride varnish every 3 and 6 months.

Also known as: Duraphat (Colgate)

Fluoride Varnish each 3 months; Fluoride Varnish each 6 months

Control Group DRUG

Twice a day brush with fluoride toothpaste.

Also known as: Colgate Total Toothpaste

Fluoride tooth paste

Eligibility Criteria

• Age: 6 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Informed Consent from parents.
• Child assent
• High risk of dental caries
• At least one sound first permanent molar (ICDAS=0)

You may not qualify if:

• Bad behaviour
• Any systemic condition, disability

Sponsors & Collaborators

• Universidad Iberoamericana: lead
• Colgate Palmolive: collaborator

MeSH Terms

Conditions

Dental Caries

Interventions

sodium fluoride topical preparation; Sodium Fluoride; Control Groups; hydrated silica gel-based toothpaste

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Sodium Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ninoska Abreu

  Universidad Iberoamericana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2015
• First Posted: October 30, 2015
• Study Start: March 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: November 4, 2016

Record last verified: 2016-11