Silver Diamine Fluoride in Preventing Occlusal Caries in Primary Teeth
Status:
Recruiting
Trial end date:
2023-07-31
Target enrollment:
Participant gender:
Summary
In Hong Kong, approximately half of the kindergarten children have dental caries (tooth
decay) and the majority (>90%) of the decayed teeth were left untreated. There is a need to
generate clinical evidence for designing an effective dental caries prevention programme for
preschool children in Hong Kong. The objective of this study is to compare the effectiveness
of 38% silver diamine fluoride (SDF), 5% sodium fluoride (NaF) varnish and placebo control in
preventing dentine cavitated caries in primary molars in preschool children when applied
semi-annually over 30 months. Around 770 preschool children attending Grade 1 in selected
kindergartens will be invited to participate in this clinical trial. Only generally healthy
children with written parental consent will be included. At baseline, clinical examination
will be conducted in the kindergarten to assess the tooth and oral hygiene status of the
included children. After the baseline examination, the children will be randomly assigned to
one of the following three study groups and the occlusal (biting) surfaces of their primary
molars will receive the corresponding interventions: Group A - semi-annual topical
application of 38% SDF; Group B - semi-annual application of 5% NaF varnish; and Group C -
semi-annual application of placebo control with tonic water. Clinical examination of the
study teeth in the children will be conducted every 6 months after the baseline to assess the
outcome of the intervention. The primary outcome is whether cavitated dentine caries lesion
is found in the treated occlusal tooth surface. The null hypothesis tested is that there is
no difference in the effectiveness of semi-annual application of 38% SDF and that of 5% NaF
varnish versus placebo control in preventing dentin occlusal caries in primary molars of
preschool children. The results of the proposed study will provide evidence to strengthen or
refute the recommendation regarding the use of SDF for preventing occlusal caries in primary
molars. The study findings will be valuable for guiding decision-making among dental
practitioners and health policymakers on whether SDF should be complemented in a school-based
caries prevention program.