Fluoride Therapies on Hypersensitive Carious Lesions in Primary Teeth
Condition: Dentin Hypersensitivity; Active Dental Caries
MeSH terms: Dental Caries; Dentin Sensitivity; Hypersensitivity
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This observational cohort study aims to evaluate the short-term (3 months) efficacy of the
      standard fluoride therapy in the German National Health System for managing hypersensitive
      carious lesions in primary teeth (fluoride varnish application), and further compare it to a
      different fluoride therapy utilizing a silver-containing fluoride agent combined with
      potassium iodide solution.
    

Detailed description: 
      A single trained investigator will screen for possible study participants of children aged
      2-5 years old, and their parents will be asked to participate in the study. The participants
      will be consecutively recruited from regular clinic attendees of the Department of Preventive
      and Pediatric Dentistry at the University of Greifswald, from whom present with active
      carious lesions (ICDAS 5) along symptoms of hypersensitivity to be treated with fluoride
      varnish, and further compared to participants treated with silver fluoride and potassium
      iodide application.

      Eligibility to the study will be determined by a single trained examiner through clinical
      findings of caries activity according to Bjørndal criteria, and reported history of
      hypersensitivity symptoms obtained from the parent/caregiver of the participant, followed by
      hypersensitivity confirmatory test using a triple syringe air blast on the exposed surface of
      the carious lesion to allocate areas with suspected dentin hypersensitivity.

      After clinical examination and obtainment of an informed consent, eligible children will be
      treated with fluoride varnish application (Duraphat®), or silver fluoride and potassium
      iodide application (Riva Star®) according to manufacturer's instructions.The participant's
      behavior shall be evaluated at the beginning, during and after treatment. Plaque Index (API)
      and Papillary Bleeding Index (PBI) will also be assessed prior to treatment and at the
      3-months mark. Procedures will be performed by six different dentists (four pediatric
      specialists and two post-graduate pediatric dentistry students), all of whom were briefed on
      the study protocol and received instructions in carrying in the interventions according to
      the manufacturer's guide, and their technical opinions regarding the performed procedures
      will be obtained following the procedure. Follow up examinations after 3 months will be done
      by a single examiner. Only one tooth per child will be included in the analysis.

      Data and information of this study will be recorded, handled, and stored in an organized and
      secure way, to allow its accurate reporting, interpretation, and verification. To assure
      confidentiality of clinical records, an unambiguous subject identification code will be used.
      Patients who are no longer willing to continue in the study will have the right to quit at
      any time without any penalty.

      All variables will be statistically analyzed using descriptive statistics, plots, and tests
      of normality. Means and standard deviations (SD) will be calculated for all quantitative
      variables, while frequencies and percentages will be calculated for categorical variables.

      Comparison between the two study groups will utilize independent samples t-test for
      quantitative normally distributed variables, and Mann-Whitney U for quantitative non-normally
      distributed variables and qualitative ordinal variables. Chi-squared and Fisher exact tests
      will be performed for comparing qualitative nominal variables between the two study groups.
      Comparing the baseline and follow-up shall be done using paired t-test when the variable is
      normally distributed, and Wilcoxon signed rank test when the variable is not normally
      distributed. For comparing lesion activity before and after treatment, McNemar test will be
      used and Friedman test for comparing the children's behavior at 3 different time points
      (before, during and after treatment).

      A Significance will be set at p<0.05. Data will be analyzed using IBM SPSS statistical
      software for windows (version 25).
    

Intervention name(s): 38% Silver Fluoride and Potassium Iodide solution (generic name; Riva Star®); Sodium fluoride varnish (generic name; Duraphat®)
Intervention type(s): Drug; Drug
Intervention description(s): 38% silver fluoride will be applied to the surface of the isolated hypersensitive carious lesion followed by application of potassium iodide solution and according to manufacturer's instructions.; 22,600 ppm sodium fluoride varnish will be applied on the surface of the affected hypersensitive active carious lesions.
Other intervention name(s): Riva Star®; Duraphat®
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride; Fluorides, Topical; Sodium fluoride topical preparation
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment