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

May 7, 2017 updated by: Livia Maria Andaló Tenuta, University of Campinas, Brazil

Retention of Fluoride Formed on Enamel by Fluoride Gel or Varnish Application and Its Release to Dental Biofilm Fluid - in Vivo Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Santa Catarina
      • Chapecó, Santa Catarina, Brazil
        • Unochapecó

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Negative control
No treatment will be applied
Experimental: Varnish 4 h
Fluoride varnish will be applied on teeth and removed after 4 hours
Drug: 5% sodium fluoride varnish
Fluoride varnish containing 22,600 ppm F, as NaF, in a neutral base
Experimental: Varnish 24 h
Fluoride varnish will be applied on teeth and removed after 24 hours
Drug: 5% sodium fluoride varnish
Fluoride varnish containing 22,600 ppm F, as NaF, in a neutral base
Experimental: Fluoride Gel
Fluoride gell will be applied on teeth and removed after 4 minutes
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in fluoride concentration in enamel days after fluoride application
Time Frame: Up to 28 days
Up to 28 days
Change in fluoride concentration in dental biofilm fluid days after fluoride application
Time Frame: Up to 28 days
Up to 28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in fluoride concentration in whole biofilm days after fluoride application
Time Frame: Up to 28 days
Up to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campinas, Brazil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

May 26, 2015

First Submitted That Met QC Criteria

June 26, 2015

First Posted (Estimate)

July 1, 2015

Study Record Updates

Last Update Posted (Actual)

May 9, 2017

Last Update Submitted That Met QC Criteria

May 7, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FOPBioq005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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