In Vivo Comparison of Salivary Fluoride Levels Following the Application of Different 5% NaF Varnishes

April 9, 2017 updated by: Danika J Downey, University of Michigan
This study will be a cross-over single blinded clinical study to evaluate the in vitro fluoride release of three different brands of 5% NaF varnish. The goal of this study is to determine if different formulations of varnish lead to differing amounts of fluoride release. Despite their similar concentrations of NaF (5%), some in vitro data have suggested that they may differ in the amount of fluoride release. Determining fluoride release of these varnishes in vivo is important in assessing both the safety and efficacy of the product.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will be a cross-over single blinded clinical study to evaluate the in vitro fluoride release of three different brands of 5% NaF varnish. Subjects will be recruited at the University of Michigan School of Dentistry and will participate in a 15 minute clinical session at the beginning of each study arm, followed by 6 saliva collection recalls. During these sessions a fluoride varnish or placebo will be applied to their teeth, and subsequent salivary samples will be taken 1 hour, 4 hours, 6 hours, 24 hours, and 48 hours after the application. All subjects will receive 3 commercially available varnishes, and a placebo varnish. Between applications there will be a minimum of 2 weeks wash-out period. The goal of this study is to determine if different formulations of varnish lead to differing amounts of fluoride release. Despite their similar concentrations of NaF (5%), some in vitro data have suggested that they may differ in the amount of fluoride release. Determining fluoride release of these varnishes in vivo is important in assessing both the safety and efficacy of the product.

Specific Aims

  1. Determine the concentration of fluoride available in the oral cavity at different time periods after the application of three different 5% NaF varnishes as measured in unstimulated human saliva.
  2. Compare the different patterns of fluoride release from each of the varnishes by comparing the fluoride concentration in saliva at corresponding time periods .
  3. Evaluate the validity of an in vitro model used to measure fluoride release from varnishes.

Percentage difference in fluoride release between the in vivo and in vitro data obtained from the same products will be compared. Because the comparison of different patterns of fluoride release from the varnishes is accomplished by analyzing the fluoride available concentration levels, it was an error to list that secondary aim as a secondary - or indeed any sort of outcome measure. The outcome measure data for "patterns of fluoride release" is exactly that which has been fully disclosed in the Primary Outcome Measure data tables. Therefore the secondary outcome measure previously listed: Compare the different patterns of fluoride release from each of the varnishes, which was really never properly an outcome measure, but an aim, has been deleted, with no loss of data transparency.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

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

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • University of Michigan School of Dentistry

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All subjects between 18-65 years of age and do not fall under any of the exclusion criteria

Exclusion Criteria:

  • Subjects with less than 20 teeth
  • Subjects with significant untreated disease to include gum disease, extensive decay, or the need for pre-medication prior to dental treatment
  • Pregnant or lactating women
  • Subjects with a history of allergy to materials to be used in the study
  • Subjects unable to produce adequate saliva for sampling
  • Subjects deemed low risk for dental caries (no history of restorative work or presence of caries lesions)
  • Subjects unable to be available for all 4 cycles of the study

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Enamel Pro
Varnish containing 5%NaF
Device: Enamel Pro
Varnish treatment containing 5% NaF
Other Names:
  • Varnish
Active Comparator: Duraphat
Varnish containing 5%NaF
Device: Duraphat
Varnish treatment containing 5% NaF
Other Names:
  • Varnish
Active Comparator: Vanish
Varnish containing 5%NaF
Device: Vanish
Varnish treatment containing 5% NaF
Other Names:
  • Varnish
Placebo Comparator: Placebo
Bland varnish containing no NaF
Device: Placebo
Bland varnish containing no NaF
Other Names:
  • Bland varnish

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fluoride Concentration and Release
Time Frame: Baseline, 1 hr, 4 hrs, 6 hrs, 26 hrs and 50 hrs
Fluoride release as measured by concentration of fluoride available in the oral cavity at different time periods after the application of 5% NaF varnish and placebo as measured in unstimulated human saliva
Baseline, 1 hr, 4 hrs, 6 hrs, 26 hrs and 50 hrs

Collaborators and Investigators

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

Sponsor

University of Michigan

Collaborators

Delta Dental Fund of Michigan

Investigators

  • Study Chair: Peter Yaman, DDS, MS, University of Michigan
  • Study Chair: Gisele Neiva, DDS, MS, University of Michigan School of Dentsitry
  • Study Chair: Joseph Dennison, DDS, MS, University of Michigan
  • Study Director: Carlos Gonzalez, DDS,MSD,PhD, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2012

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

June 10, 2012

First Submitted That Met QC Criteria

June 26, 2012

First Posted (Estimate)

June 27, 2012

Study Record Updates

Last Update Posted (Actual)

May 22, 2017

Last Update Submitted That Met QC Criteria

April 9, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00062943

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

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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