BACKGROUND
Tooth decay is a significant public health problem globally. The caries-arrest effectiveness of 38% silver diamine fluoride (SDF) has been well documented. However, information on the caries preventive effect of SDF on primary teeth is insufficient.
OBJECTIVE
The aim of this trial is to investigate the effectiveness of semi-annual application of 38% SDF and that of 5% sodium fluoride (NaF) varnish when compared to placebo control in preventing occlusal caries in primary molars of preschool children over 30 months.
METHODS
This three-arm, parallel design, double-blind, randomised controlled trial involves 791 preschool children. Children are randomly allocated to receive one of the three interventions as follows; Group 1) 38% SDF, Group 2) 5% NaF varnish, and Group 3) placebo control with tonic water. The intervention and dental examination will be carried out every 6 months. A parent-administered questionnaire including the children’s demographic background and oral health-related behaviours has been collected at baseline. Follow-up examinations to detect new caries development will be conducted every 6 months by a masked examiner. Caries development will be diagnosed at the cavitation level. Chi-square tests and logistic regression analyses will be adopted. A two-level logistic regression analysis will be performed to investigate the effects of the study interventions and other potential confounding factors on the development of occlusal caries.
RESULTS
Result: To date, a total of 791 children are participating in the study.
CONCLUSIONS
If SDF application is more effective than NaF varnish in preventing caries on occlusal surfaces of primary teeth, it can be a preferred choice for caries prevention in a kindergarten-based program. Results of this trial will provide valuable clinical evidence for the development of oral health strategies and policy on promotion of child oral health
CLINICALTRIAL
ClinicalTrials.gov NCT05084001