JMIR Publications

ABSTRACT

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 Clinical Trial: ClinicalTrials.gov NCT05084001