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

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02486458
• Other study ID #: FOPBioq005
• Status: Completed
• Phase: Early Phase 1
• First received: May 26, 2015
• Last updated: May 7, 2017
• Start date: April 2015
• Est. completion date: December 2016

Study information

• Verified date: May 2017
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries

Intervention

Drug:
• 5% sodium fluoride varnish
Fluoride varnish containing 22,600 ppm F, as NaF, in a neutral base
• 1.23% sodium fluoride acidic gel
Fluoride gel containing 12,300 ppm F (as NaF) in an acidic pH (by addition of phosphoric acid)

Locations

Country	Name	City	State
Brazil	Unochapecó	Chapecó	Santa Catarina

Sponsors (1)

Lead Sponsor	Collaborator
University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in fluoride concentration in enamel days after fluoride application		Up to 28 days
Primary	Change in fluoride concentration in dental biofilm fluid days after fluoride application		Up to 28 days
Secondary	Change in fluoride concentration in whole biofilm days after fluoride application		Up to 28 days