NCT04075474

Preventing Early Childhood Caries With Silver Diamine Fluoride

Preventing Early Childhood Caries With Silver Diamine Fluoride - a Randomised Clinical Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 730 (estimated)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 3 Years – 4 Years
• Healthy volunteers: Accepted

Summary

Background: Silver diamine fluoride (SDF) solution is effective in arresting early childhood caries (ECC). Previous studies suggested that it might exert a preventive effect in managing ECC. However, no well-designed clinical trial has been performed to study this topic. The aim of this randomised clinical trial is to assess whether 38% SDF is superior to 5% sodium fluoride (NaF) varnish in preventing new carious lesions in primary anterior teeth. Methods/Design: This is a Phase II single-centre randomized, double-blind, active-controlled, parallel-group pragmatic trial. The hypothesis tested is that 38% SDF is more effective than 5% NaF in preventing new caries development in primary anterior teeth. Approximately 2,100 three-year-old kindergarten children who are generally healthy and with parental consent will be recruited. This sample size is sufficient for an appropriate statistical analysis of superiority trial with power at 80%, allowing for a 15% drop-out rate. Stratified randomization will be adopted for the intervention allocation. The intervention is either 38% SDF or 5% NaF (as positive control) therapy on primary upper anterior teeth. Dental examination followed by fluoride therapy will be conducted every six months until 30 months in kindergartens by a single examiner. The examiner, children and children's parents will be blinded to the treatment allocation. Questionnaire survey will be conducted to study the children's oral health-related behaviours and their socioeconomic backgrounds. Discussion: The effectiveness of 38% SDF in preventing ECC remains uncertain. If the results are as anticipated, it will help change the standard of care that using 5% NaF for ECC prevention. In addition, the results will be widely available and increase adoption of SDF in other countries to reduce the global burden of ECC.

Conditions

• Dental Caries

Interventions

Type	Name	Description
DEVICE	silver diamine fluoride	38% SDF on primary upper anterior teeth
DEVICE	sodium fluoride	5% NaF on primary upper anterior teeth

Timeline

• Start date: 2020-10-27
• Primary completion: 2023-06-30
• Completion: 2023-06-30
• First posted: 2019-08-30
• Last updated: 2022-12-09

Locations

1 site across 1 country: Hong Kong

Regulatory

• FDA-regulated device study