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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Delta Dental Fund of Michigan
Information provided by (Responsible Party):
Danika J Downey, University of Michigan
ClinicalTrials.gov Identifier:
NCT01629290
First received: June 10, 2012
Last updated: August 5, 2012
Last verified: August 2012
  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. 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.


Condition Intervention
Dental Caries
Device: Dental Varnish (Enamel Pro, Duraphat, Vanish)
Device: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
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 University of Michigan:

Primary Outcome Measures:
  • 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 [ Time Frame: 48 Hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare the different patterns of fluoride release from each of the varnishes [ Time Frame: 48 Hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: June 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Enamel Pro 5% NaF Device: Dental Varnish (Enamel Pro, Duraphat, Vanish)
3 varnishes with 5% NaF active ingredient and one bland varnish (No NaF)
Other Names:
  • Enamel Pro 5% NaF
  • Duraphat 5% NaF
  • Vanish 5% NaF
Active Comparator: Duraphat 5% NaF Device: Dental Varnish (Enamel Pro, Duraphat, Vanish)
3 varnishes with 5% NaF active ingredient and one bland varnish (No NaF)
Other Names:
  • Enamel Pro 5% NaF
  • Duraphat 5% NaF
  • Vanish 5% NaF
Active Comparator: Vanish 5% NaF Device: Dental Varnish (Enamel Pro, Duraphat, Vanish)
3 varnishes with 5% NaF active ingredient and one bland varnish (No NaF)
Other Names:
  • Enamel Pro 5% NaF
  • Duraphat 5% NaF
  • Vanish 5% NaF
Placebo Comparator: Placebo Device: Placebo
0.5 mls applied topically to buccal surfaces of teeth

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Danika J Downey, Graduate Student, Restorative Dentistry, University of Michigan
ClinicalTrials.gov Identifier: NCT01629290     History of Changes
Other Study ID Numbers: HUM00062943
Study First Received: June 10, 2012
Last Updated: August 5, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014