Preventing Caries With Silver Diamine Fluoride
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 2

Summary: 
      Background: Early childhood caries (tooth decay, ECC) affected 55% 5-year-old Hong Kong
      children, and 70% of these children had gross destruction of the upper anterior teeth with
      negative long-term impacts on health and quality of life. The existing standard of care for
      prevention of ECC, topical application of 5% sodium fluoride (NaF) varnish, is inadequate. In
      Hong Kong and other parts of the world, 38% silver diamine fluoride (SDF) solution, applied
      topically to cavities, is used to arrest ECC. Work published by our research group suggests
      it likely also has a preventive effect of ECC. Moreover, SDF has been shown to be preventive
      in tooth decay in permanent teeth. Nevertheless, no pivotal clinical trial has been performed
      to support a change in usual practice.

      Aim: This is a Phase II single-centre randomized, double-blind, active-controlled,
      parallel-group pragmatic trial with two arms to assess the effectiveness of 38% SDF and 5%
      NaF in preventing new caries lesions in primary anterior teeth. Methods: 688 three-year-old
      kindergarten children who are healthy will be recruited, stratified by school, and block
      randomized to receive either 38% SDF (treatment group) or 5% NaF (standard treatment group)
      therapy on primary upper anterior teeth. This sample size is sufficient for a superiority
      trial with power at 90%, allowing for a 15% dropout rate. The primary outcome is the number
      of sound tooth surfaces that become cavitated caries per child at 12-month follow-up. The
      secondary outcome is the number of carious tooth surfaces developed after baseline that
      become arrested at 12-month for each child. Dental examinations for the status of caries
      (active or arrested) will be conducted by the same calibrated examiner. The examiner,
      children and children's parents will be blind to treatment allocation. Parents will be
      surveyed to study the children's oral health-related behaviours and socioeconomic
      backgrounds, which will allow the adjustment for effect modification. Possible results and
      implications: If the results are as anticipated, it will help change the standard of care for
      caries prevention. If adopted in Hong Kong, SDF therapy will prevent 20,800 (13% of the
      160,000) kindergarten children from having caries developed in their anterior teeth, thus
      reduce significantly the burden of ECC of the children and related stress of their family.
      Moreover, the results will be widely available and increase adoption of SDF in other
      countries to reduce the global burden of ECC among children.
    


Intervention name(s): SDF; NaF
Intervention type(s): Device; Device
Intervention description(s): 38% silver diamine fluoride solution; 5% sodium fluoride varnish
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 5% NaF and 38% SDF
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention