Long-term Release of Fluoride Formed on Enamel by Fluoride Gel or Varnish to Biofilm Fluid

NCT02486458 | Completed Early Phase 1

• 1 other identifier: FOPBioq005
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Caries

Keywords

Fluoride; Biofilm fluid; Calcium fluoride; Topical

Outcome Measures

Primary Outcomes (2)

• Change in fluoride concentration in enamel days after fluoride application

  Up to 28 days

• Change in fluoride concentration in dental biofilm fluid days after fluoride application

  Up to 28 days

Secondary Outcomes (1)

• Change in fluoride concentration in whole biofilm days after fluoride application

  Up to 28 days

Study Arms (4)

Negative control

NO INTERVENTION

No treatment will be applied

Varnish 4 h

EXPERIMENTAL

Fluoride varnish will be applied on teeth and removed after 4 hours

Drug: 5% sodium fluoride varnish

Varnish 24 h

EXPERIMENTAL

Fluoride varnish will be applied on teeth and removed after 24 hours

Drug: 5% sodium fluoride varnish

Fluoride Gel

EXPERIMENTAL

Fluoride gell will be applied on teeth and removed after 4 minutes

Drug: 1.23% sodium fluoride acidic gel

Interventions

5% sodium fluoride varnish DRUG

Fluoride varnish containing 22,600 ppm F, as NaF, in a neutral base

Varnish 24 h; Varnish 4 h

1.23% sodium fluoride acidic gel DRUG

Fluoride gel containing 12,300 ppm F (as NaF) in an acidic pH (by addition of phosphoric acid)

Fluoride Gel

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Good general health
• Good oral health
• At least 5 teeth in each hemiarch
• All 4 superior incisors in the mouth
• Rapid biofilm forming

You may not qualify if:

• Pregnancy
• Intake of medication that reduces salivary flow
• Chronic diseases
• Smokers
• Orthodontic appliances
• Dental prosthesis
• Allergy to fluoride varnish components

Sponsors & Collaborators

• University of Campinas, Brazil: lead

Study Sites (1)

Unochapecó

Chapecó, Santa Catarina, Brazil

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, MSc, PhD

Study Record Dates

• First Submitted: May 26, 2015
• First Posted: July 1, 2015
• Study Start: April 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: May 9, 2017

Record last verified: 2017-05

Locations

BR (1)