In Vivo Comparison of Salivary Fluoride Levels Following the Application of Different 5% NaF Varnishes
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      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.
    

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.
    

Intervention name(s): Enamel Pro; Duraphat; Vanish; Placebo
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Varnish treatment containing 5% NaF; Varnish treatment containing 5% NaF; Varnish treatment containing 5% NaF; Bland varnish containing no NaF
Other intervention name(s): Varnish; Varnish; Varnish; Bland varnish
Intervention MeSH terms: Sodium fluoride topical preparation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment