Effectiveness of SDF in Arresting Dental Caries in Preschool Children
Condition: Early Childhood Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 3

Summary: 
      Background: Tooth decay in children (Early childhood caries, or ECC) is a common childhood
      disease. Poor dentition significantly affects the nutrition, growth, development and general
      health of children. Conventional dental care for ECC is neither affordable nor accessible,
      particularly for the disadvantaged communities. Silver diamine fluoride (SDF) is a safe,
      cost-effective caries-arresting agent that appears to conform to the World Health
      Organization's Millennium Goals. SDF is commercially available at 38% and 12%, and topically
      used yearly or half-yearly to arrest ECC. The SDF regimens used for ECC treatment lack an
      evidence base. Therefore it is necessary to find the most suitable SDF concentration and
      application interval to arrest ECC. The purpose of this randomised controlled trial is to
      compare the efficacy of two commercially available SDF solutions at pre-prepared
      concentrations of 38% and 12% when applied at yearly or half-yearly intervals over 36 months
      in arresting caries in primary teeth.

      Methods / Design: This double-blinded study has recruited 888 kindergarten children aged 3-4
      years with caries. The sample size is sufficient for the appropriate statistical analyses.
      The children were classified into high and low caries rates and equally allocated into four
      groups for the caries treatment:

      Group A - semi-annual application of 12% SDF; Group B - annual application of 12% SDF; Group
      C - semi-annual application of 38% SDF; Group D - annual application of 38% SDF. The children
      will be followed for 36 months in their kindergartens until they enter primary school.
      Clinical examinations at 6-month intervals will be conducted to assess whether the caries are
      arrested. Information on confounding factors, such as oral hygiene habits and the use of
      other fluoride agents, will be collected through a parental questionnaire at the baseline and
      follow-ups.

      Discussion: This study will help determine the most suitable SDF concentration and
      application interval to arrest caries in children. Because SDF use for caries arrest is
      painless, simple, and low-cost, it can be widely recommended and promoted for caries control
      in young children or those with difficulty accessing and affording conventional dental care.
      The applicability of the findings and their impact on public health would be immense.
    


Intervention name(s): 12% SDF; 38% SDF
Intervention type(s): Drug; Drug
Intervention description(s): 12% silver diamine fluoride solution, of which the capability of arresting dental caries is not sure; 38% silver diamine fluoride solution, of which the capability of arresting dental caries is known
Other intervention name(s): 12% silver diamine fluoride; 38% silver diamine fluoride
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: silver diamine fluoride; randomized clinical trial; caries; children; fluoride