Preventing Early Childhood Caries With Silver Diamine Fluoride

NCT04075474 | Unknown Phase 2 FDA Device

• 1 other identifier: UW18-619
• Study Type: interventional
• Target: 730
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• caries prevention

  the number of sound tooth surfaces that become cavitated caries per child

  at 30-month follow-up

Study Arms (2)

silver diamine fluoride

EXPERIMENTAL

38% silver diamine fluoride

Device: silver diamine fluoride

sodium fluoride

ACTIVE COMPARATOR

5% sodium fluoride

Device: sodium fluoride

Interventions

silver diamine fluoride DEVICE

38% SDF on primary upper anterior teeth

silver diamine fluoride

sodium fluoride DEVICE

5% NaF on primary upper anterior teeth

sodium fluoride

Eligibility Criteria

• Age: 3 Years - 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• generally healthy, with parental consents

You may not qualify if:

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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Local kindergartens

Hong Kong, Hong Kong

RECRUITING

Related Publications (2)

• Zheng FM, Yan IG, Duangthip D, Lo ECM, Gao SS, Chu CH. Randomized Clinical Trial on Caries Prevention of Silver Diamine Fluoride. J Dent Res. 2025 Sep 9:220345251363837. doi: 10.1177/00220345251363837. Online ahead of print.

  PMID: 40926346 DERIVED

• Gao SS, Chen KJ, Duangthip D, Wong MCM, Lo ECM, Chu CH. Preventing early childhood caries with silver diamine fluoride: study protocol for a randomised clinical trial. Trials. 2020 Feb 4;21(1):140. doi: 10.1186/s13063-020-4088-7.

  PMID: 32019596 DERIVED

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Chun Hung Chu, PhD

CONTACT

(+852)28590287; chchu@hku.hk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: August 30, 2019
• Study Start: October 27, 2020
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: December 9, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)