Preventing Early Childhood Caries With Silver Diamine Fluoride

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04075474
• Other study ID #: UW18-619
• Status: Recruiting
• Phase: Phase 2
• Start date: October 27, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: December 2022
• Source: The University of Hong Kong
• Contact: Chun Hung Chu, PhD
• Phone: (+852)28590287
• Email: chchu[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 730
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 4 Years

Eligibility

Inclusion Criteria:

• generally healthy, with parental consents

Exclusion Criteria:

• uncooperative and difficult to manage, have major systemic diseases such as porphyria, or are on long-term medication such as anti-epileptic drugs.

Related Conditions & MeSH terms

• Dental Caries

Intervention

Device:
• silver diamine fluoride
38% SDF on primary upper anterior teeth
• sodium fluoride
5% NaF on primary upper anterior teeth

Locations

Country	Name	City	State
Hong Kong	Local kindergartens	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	caries prevention	the number of sound tooth surfaces that become cavitated caries per child	at 30-month follow-up