Preventing Early Childhood Caries With Silver Diamine Fluoride
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|ClinicalTrials.gov Identifier: NCT04075474|
Recruitment Status : Recruiting
First Posted : August 30, 2019
Last Update Posted : September 30, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Dental Caries||Device: silver diamine fluoride Device: sodium fluoride||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||730 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Preventing Early Childhood Caries With Silver Diamine Fluoride - a Randomised Clinical Trial|
|Actual Study Start Date :||September 18, 2019|
|Estimated Primary Completion Date :||June 30, 2022|
|Estimated Study Completion Date :||June 30, 2022|
Experimental: silver diamine fluoride
38% silver diamine fluoride
Device: silver diamine fluoride
38% SDF on primary upper anterior teeth
Active Comparator: sodium fluoride
5% sodium fluoride
Device: sodium fluoride
5% NaF on primary upper anterior teeth
- caries prevention [ Time Frame: at 30-month follow-up ]the number of sound tooth surfaces that become cavitated caries per child
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04075474
|Contact: Chun Hung Chu, PhD||(+852)firstname.lastname@example.org|
|Hong Kong, Hong Kong|