Effectiveness of Silver Diamine Fluoride (SDF) in Arresting Cavitated Caries Lesions
Condition: Cavities of Teeth
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is a Phase III, multisite, randomized, placebo-controlled trial, with two parallel
      groups. The groups are SDF or placebo and they are applied every 6 months. The primary
      hypothesis of the trial is that SDF is better than placebo for stopping cavities with dentin
      exposed in baby teeth when assessed at 6 months after initial application.
    

Detailed description: 
      This trial is a phase III, multicenter, randomized, placebo-controlled superiority trial,
      with two parallel groups (placebo vs. SDF applied to cavitated lesions) involving a total of
      1144 children with the primary outcome assessed at 6 months after initial treatment.

      One thousand one hundred forty four children, 12-71 months of age, from early childhood
      education programs, such as Head Start centers, Early Head Start centers, and equivalent
      city/state subsidized preschool programs, or children attending dental clinics associated
      with the clinical trial sites, will be randomized, in two cohorts. Trial visits will occur at
      baseline, 3 months, 6 months, and 8 months. SDF/placebo will be applied at baseline and 6
      months. Parents/legal guardians will be called 24 to 48 hours after the SDF/placebo
      application to assess adverse events and unanticipated problems and in-person visits for
      safety exams will be available for all child participants approximately 24 to 48 hours after
      SDF/placebo application. This visit could happen before or after the 24- to 48-hour call with
      the parent or legal guardian, but every attempt will be made so that the call occurs prior to
      the 24- to 48-hour visit. Additionally, intermediate contacts at 1.5 months, 4.5 months, and
      7 months will occur to determine if the child needs an additional visit to assess pain,
      lesion progression, etc. and to maintain contact with the participant.

      Randomization to SDF application (treatment) or placebo (control) will be at the
      participant-level; all teeth within a participant that meet the inclusion criteria will
      receive the same trial product. Both treatment and control will be dispensed from identical
      unit-dose ampules coded and labeled to ensure masking of all trial personnel. The number of
      ampules required to treat all carious lesions in the participant's mouth will be recorded. No
      caries removal will be performed. Teeth will be cleaned with a toothbrush and will be dried
      with cotton/gauze, and the solution will be painted on the dentin of each targeted cavitated
      lesion using a standardized applicator. Following application, the tooth will be blotted dry
      with gauze.

      At each clinical visit International Caries Detection and Assessment System (ICDAS)
      examinations, including cavitated lesion hardness assessments, soft tissue assessments and
      questionnaires on dental discomfort, family impact and treatment satisfaction and
      acceptability will be collected.
    

Intervention name(s): Silver Diamine Fluoride; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SDF will be applied twice during the study; This is being compared to the SDF and will also be applied twice
Other intervention name(s): Diammine Silver Fluoride
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment