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

Primary Purpose

Dental Caries

Status
Completed
Phase
Early Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
5% sodium fluoride varnish
1.23% sodium fluoride acidic gel
Sponsored by
University of Campinas, Brazil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries focused on measuring Fluoride, Biofilm fluid, Calcium fluoride, Topical

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Unochapecó

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Negative control

Varnish 4 h

Varnish 24 h

Fluoride Gel

Arm Description

No treatment will be applied

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in fluoride concentration in whole biofilm days after fluoride application

Full Information

First Posted
May 26, 2015
Last Updated
May 7, 2017
Sponsor
University of Campinas, Brazil
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1. Study Identification

Unique Protocol Identification Number
NCT02486458
Brief Title
Long-term Release of Fluoride Formed on Enamel by Fluoride Gel or Varnish to Biofilm Fluid
Official Title
Retention of Fluoride Formed on Enamel by Fluoride Gel or Varnish Application and Its Release to Dental Biofilm Fluid - in Vivo Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campinas, Brazil

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
Fluoride, Biofilm fluid, Calcium fluoride, Topical

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Negative control
Arm Type
No Intervention
Arm Description
No treatment will be applied
Arm Title
Varnish 4 h
Arm Type
Experimental
Arm Description
Fluoride varnish will be applied on teeth and removed after 4 hours
Arm Title
Varnish 24 h
Arm Type
Experimental
Arm Description
Fluoride varnish will be applied on teeth and removed after 24 hours
Arm Title
Fluoride Gel
Arm Type
Experimental
Arm Description
Fluoride gell will be applied on teeth and removed after 4 minutes
Intervention Type
Drug
Intervention Name(s)
5% sodium fluoride varnish
Intervention Description
Fluoride varnish containing 22,600 ppm F, as NaF, in a neutral base
Intervention Type
Drug
Intervention Name(s)
1.23% sodium fluoride acidic gel
Intervention Description
Fluoride gel containing 12,300 ppm F (as NaF) in an acidic pH (by addition of phosphoric acid)
Primary Outcome Measure Information:
Title
Change in fluoride concentration in enamel days after fluoride application
Time Frame
Up to 28 days
Title
Change in fluoride concentration in dental biofilm fluid days after fluoride application
Time Frame
Up to 28 days
Secondary Outcome Measure Information:
Title
Change in fluoride concentration in whole biofilm days after fluoride application
Time Frame
Up to 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Unochapecó
City
Chapecó
State/Province
Santa Catarina
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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