Preventing Early Childhood Caries With Silver Diamine Fluoride
NCT ID: NCT04075474
Last Updated: 2022-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
730 participants
INTERVENTIONAL
2020-10-27
2023-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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silver diamine fluoride
38% silver diamine fluoride
silver diamine fluoride
38% SDF on primary upper anterior teeth
sodium fluoride
5% sodium fluoride
sodium fluoride
5% NaF on primary upper anterior teeth
Interventions
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silver diamine fluoride
38% SDF on primary upper anterior teeth
sodium fluoride
5% NaF on primary upper anterior teeth
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
3 Years
4 Years
ALL
Yes
Sponsors
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The University of Hong Kong
OTHER
Responsible Party
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Chun-Hung Chu
Clinical Professor
Locations
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Local kindergartens
Hong Kong, , Hong Kong
Countries
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Central Contacts
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References
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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.
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.
Other Identifiers
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UW18-619
Identifier Type: -
Identifier Source: org_study_id