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Article: Preventing early childhood caries with silver diamine fluoride: study protocol for a randomised clinical trial

TitlePreventing early childhood caries with silver diamine fluoride: study protocol for a randomised clinical trial
Authors
KeywordsSilver diamine fluoride
Sodium fluoride
Children
Caries
Prevention
Issue Date2020
PublisherBioMed Central Ltd. The Journal's web site is located at http://www.trialsjournal.com/
Citation
Trials, 2020, v. 21 n. 1, p. article no. 140 How to Cite?
AbstractBACKGROUND: Silver diamine fluoride (SDF) solution is effective in arresting early childhood caries (ECC). Previous studies have suggested that it might exert a preventive effect in managing ECC. However, no well-designed clinical trials have yet been performed to study the effect of SDF on caries prevention. The objective of this randomised clinical trial is to determine whether 38% SDF solution 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, randomised, double-blind, active-controlled, parallel-group pragmatic trial. The hypothesis tested is that 38% SDF would be more effective than 5% NaF in preventing new caries development in primary anterior teeth. Approximately 730 3-year-old children who are generally healthy and with parental consent will be recruited from Hong Kong kindergartens. This sample size will be sufficient for appropriate statistical analysis of a superiority trial with 90% power, allowing for a 20% drop-out rate. Stratified randomisation will be adopted for allocating the intervention. The intervention will either be 38% SDF or 5% NaF (as a positive control) therapy on primary upper anterior teeth. A single trained examiner will conduct a dental examination every 6 months until 30 months in kindergarten. Another operator will provide fluoride therapy immediately after each dental examination. The examiner, children and children's parents will be blinded to the treatment allocation. A questionnaire survey will be conducted to study the children's oral health-related behaviours and socioeconomic backgrounds. Chi-square tests, t tests, regression analyses and survival analyses will be adopted for data analysis. DISCUSSION: The effectiveness of 38% SDF in preventing ECC remains uncertain. If the results are as anticipated, care standards using 5% NaF for ECC prevention will be changed. In addition, the results will be widely available and increase the adoption of SDF in other countries to reduce the global burden of ECC. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04075474. Registered on 30 Aug 2019.
Persistent Identifierhttp://hdl.handle.net/10722/286604
ISSN
2018 Impact Factor: 1.975
2015 SCImago Journal Rankings: 1.077
PubMed Central ID

 

DC FieldValueLanguage
dc.contributor.authorGao, SS-
dc.contributor.authorChen, KJ-
dc.contributor.authorDuangthip, D-
dc.contributor.authorWong, MCM-
dc.contributor.authorLo, ECM-
dc.contributor.authorChu, CH-
dc.date.accessioned2020-09-04T13:27:55Z-
dc.date.available2020-09-04T13:27:55Z-
dc.date.issued2020-
dc.identifier.citationTrials, 2020, v. 21 n. 1, p. article no. 140-
dc.identifier.issn1745-6215-
dc.identifier.urihttp://hdl.handle.net/10722/286604-
dc.description.abstractBACKGROUND: Silver diamine fluoride (SDF) solution is effective in arresting early childhood caries (ECC). Previous studies have suggested that it might exert a preventive effect in managing ECC. However, no well-designed clinical trials have yet been performed to study the effect of SDF on caries prevention. The objective of this randomised clinical trial is to determine whether 38% SDF solution 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, randomised, double-blind, active-controlled, parallel-group pragmatic trial. The hypothesis tested is that 38% SDF would be more effective than 5% NaF in preventing new caries development in primary anterior teeth. Approximately 730 3-year-old children who are generally healthy and with parental consent will be recruited from Hong Kong kindergartens. This sample size will be sufficient for appropriate statistical analysis of a superiority trial with 90% power, allowing for a 20% drop-out rate. Stratified randomisation will be adopted for allocating the intervention. The intervention will either be 38% SDF or 5% NaF (as a positive control) therapy on primary upper anterior teeth. A single trained examiner will conduct a dental examination every 6 months until 30 months in kindergarten. Another operator will provide fluoride therapy immediately after each dental examination. The examiner, children and children's parents will be blinded to the treatment allocation. A questionnaire survey will be conducted to study the children's oral health-related behaviours and socioeconomic backgrounds. Chi-square tests, t tests, regression analyses and survival analyses will be adopted for data analysis. DISCUSSION: The effectiveness of 38% SDF in preventing ECC remains uncertain. If the results are as anticipated, care standards using 5% NaF for ECC prevention will be changed. In addition, the results will be widely available and increase the adoption of SDF in other countries to reduce the global burden of ECC. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04075474. Registered on 30 Aug 2019.-
dc.languageeng-
dc.publisherBioMed Central Ltd. The Journal's web site is located at http://www.trialsjournal.com/-
dc.relation.ispartofTrials-
dc.rightsTrials. Copyright © BioMed Central Ltd.-
dc.rightsThis work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.-
dc.subjectSilver diamine fluoride-
dc.subjectSodium fluoride-
dc.subjectChildren-
dc.subjectCaries-
dc.subjectPrevention-
dc.titlePreventing early childhood caries with silver diamine fluoride: study protocol for a randomised clinical trial-
dc.typeArticle-
dc.identifier.emailDuangthip, D: dduang@hku.hk-
dc.identifier.emailWong, MCM: mcmwong@hku.hk-
dc.identifier.emailLo, ECM: edward-lo@hku.hk-
dc.identifier.emailChu, CH: chchu@hku.hk-
dc.identifier.authorityDuangthip, D=rp02457-
dc.identifier.authorityWong, MCM=rp00024-
dc.identifier.authorityLo, ECM=rp00015-
dc.identifier.authorityChu, CH=rp00022-
dc.description.naturepublished_or_final_version-
dc.identifier.doi10.1186/s13063-020-4088-7-
dc.identifier.pmid32019596-
dc.identifier.pmcidPMC7001262-
dc.identifier.scopuseid_2-s2.0-85078962703-
dc.identifier.hkuros313936-
dc.identifier.volume21-
dc.identifier.issue1-
dc.identifier.spagearticle no. 140-
dc.identifier.epagearticle no. 140-
dc.publisher.placeUnited Kingdom-

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