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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Negative control

No treatment will be applied

Group Type NO_INTERVENTION

No interventions assigned to this group

Varnish 4 h

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

Group Type EXPERIMENTAL

5% sodium fluoride varnish

Intervention Type DRUG

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

Varnish 24 h

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

Group Type EXPERIMENTAL

5% sodium fluoride varnish

Intervention Type DRUG

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

Fluoride Gel

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

Group Type EXPERIMENTAL

1.23% sodium fluoride acidic gel

Intervention Type DRUG

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

Interventions

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5% sodium fluoride varnish

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

Intervention Type DRUG

1.23% sodium fluoride acidic gel

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes