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Trial record 81 of 292 for:    Sodium Fluoride OR Duraphat

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

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ClinicalTrials.gov Identifier: NCT02486458
Recruitment Status : Completed
First Posted : July 1, 2015
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Livia Maria Andaló Tenuta, University of Campinas, Brazil

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.

Condition or disease Intervention/treatment Phase
Dental Caries Drug: 5% sodium fluoride varnish Drug: 1.23% sodium fluoride acidic gel Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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 Start Date : April 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2016

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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)




Primary Outcome Measures :
  1. Change in fluoride concentration in enamel days after fluoride application [ Time Frame: Up to 28 days ]
  2. Change in fluoride concentration in dental biofilm fluid days after fluoride application [ Time Frame: Up to 28 days ]

Secondary Outcome Measures :
  1. Change in fluoride concentration in whole biofilm days after fluoride application [ Time Frame: Up to 28 days ]


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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02486458


Locations
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Brazil
Unochapecó
Chapecó, Santa Catarina, Brazil
Sponsors and Collaborators
University of Campinas, Brazil

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Responsible Party: Livia Maria Andaló Tenuta, DDS, MSc, PhD, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT02486458     History of Changes
Other Study ID Numbers: FOPBioq005
First Posted: July 1, 2015    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Keywords provided by Livia Maria Andaló Tenuta, University of Campinas, Brazil:
Fluoride
Biofilm fluid
Calcium fluoride
Topical
Additional relevant MeSH terms:
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Listerine
Fluorides
Sodium Fluoride
Fluorides, Topical
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents