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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01629290
First Posted: June 27, 2012
Last Update Posted: May 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Delta Dental Fund of Michigan
Information provided by (Responsible Party):
Danika J Downey, University of Michigan
  Purpose
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.

Condition Intervention
Dental Caries Device: Enamel Pro Device: Duraphat Device: Vanish Device: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: In Vivo Comparison of Salivary Fluoride Levels Following the Application of Different 5% NaF Varnishes

Resource links provided by NLM:


Further study details as provided by Danika J Downey, University of Michigan:

Primary Outcome Measures:
  • 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


Enrollment: 15
Study Start Date: June 2012
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Enamel Pro
Varnish containing 5%NaF
Device: Enamel Pro
Varnish treatment containing 5% NaF
Other Name: Varnish
Active Comparator: Duraphat
Varnish containing 5%NaF
Device: Duraphat
Varnish treatment containing 5% NaF
Other Name: Varnish
Active Comparator: Vanish
Varnish containing 5%NaF
Device: Vanish
Varnish treatment containing 5% NaF
Other Name: Varnish
Placebo Comparator: Placebo
Bland varnish containing no NaF
Device: Placebo
Bland varnish containing no NaF
Other Name: Bland varnish

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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): NCT01629290


Locations
United States, Michigan
University of Michigan School of Dentistry
Ann Arbor, Michigan, United States, 48104
Sponsors and Collaborators
University of Michigan
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
  More Information

Responsible Party: Danika J Downey, Graduate Student, Restorative Dentistry, University of Michigan
ClinicalTrials.gov Identifier: NCT01629290     History of Changes
Other Study ID Numbers: HUM00062943
First Submitted: June 10, 2012
First Posted: June 27, 2012
Results First Submitted: February 1, 2017
Results First Posted: May 22, 2017
Last Update Posted: May 22, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides
Sodium fluoride topical preparation
Sodium Fluoride
Listerine
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents