Overview

This trial is active, not recruiting.

Condition dental caries
Treatments 5% sodium fluoride varnish, 1.23% sodium fluoride acidic gel
Phase phase 0
Sponsor University of Campinas, Brazil
Start date April 2015
End date December 2015
Trial size 62 participants
Trial identifier NCT02486458, FOPBioq005

Summary

The anticaries effect of professional fluoride application has been associated with the formation of calcium fluoride-like products ("CaF2") on dental surface, which may function as a slow release fluoride reservoir. Among professional fluoride products, fluoride gel and varnish are the most important, and have different soluble fluoride concentrations, pHs and vehicles. Although the concentration of fluoride formed on enamel after the use of both is similar, the retention of these reaction products is unknown. Also, it is unknown the capacity of these reservoirs to enhance dental biofilm fluid with fluoride. Moreover, the effect of the varnish application time on these parameters is unknown. Therefore, the aim of this study is to compare the capacity of fluoride gel and varnish to form fluoride reservoirs on enamel and increase dental biofilm fluid fluoride concentration with time. Rapid biofilm-forming individuals will be selected to participate and divided into 4 experimental groups: 1. Negative control: no treatment; 2. Varnish 4 hours: fluoride varnish will be applied and kept on teeth for 4 hours; 3. Varnish 24 h: fluoride varnish will be applied on teeth and kept for 24 h; and 4. Gel: Fluoride gel will be applied on teeth. Microbiopsies of enamel will be obtained by a microbiospy technique to assess fluoride concentration before, 7 and 28 days after the treatments. Dental biofilm will be collected before and 3, 7, 14 and 28 days after treatments. Fluoride concentration on enamel and in the biofilm fluid will be determined by an ion-specific electrode. Data will be analyzed statistically comparing the groups and collection times.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose prevention
Arm
(No Intervention)
No treatment will be applied
(Experimental)
Fluoride varnish will be applied on teeth and removed after 4 hours
5% sodium fluoride varnish
Fluoride varnish containing 22,600 ppm F, as NaF, in a neutral base
(Experimental)
Fluoride varnish will be applied on teeth and removed after 24 hours
5% sodium fluoride varnish
Fluoride varnish containing 22,600 ppm F, as NaF, in a neutral base
(Experimental)
Fluoride gell will be applied on teeth and removed after 4 minutes
1.23% sodium fluoride acidic gel
Fluoride gel containing 12,300 ppm F (as NaF) in an acidic pH (by addition of phosphoric acid)

Primary Outcomes

Measure
Change in fluoride concentration in enamel days after fluoride application
time frame: Up to 28 days
Change in fluoride concentration in dental biofilm fluid days after fluoride application
time frame: Up to 28 days

Secondary Outcomes

Measure
Change in fluoride concentration in whole biofilm days after fluoride application
time frame: Up to 28 days

Eligibility Criteria

Male or female participants from 18 years up to 30 years old.

Inclusion Criteria: - Good general health - Good oral health - At least 5 teeth in each hemiarch - All 4 superior incisors in the mouth - Rapid biofilm forming Exclusion Criteria: - Pregnancy - Intake of medication that reduces salivary flow - Chronic diseases - Smokers - Orthodontic appliances - Dental prosthesis - Allergy to fluoride varnish components

Additional Information

Official title Retention of Fluoride Formed on Enamel by Fluoride Gel or Varnish Application and Its Release to Dental Biofilm Fluid - in Vivo Study
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Campinas, Brazil.