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dc.contributor.authorMilgrom, Peter
dc.contributor.authorTut, Ohnmar
dc.contributor.authorRothen, Marilynn
dc.contributor.authorMancl, Lloyd
dc.contributor.authorGallen, Marcelle
dc.contributor.authorTanzer, Jason M
dc.date.accessioned2020-10-25T23:58:41Z
dc.date.available2020-10-25T23:58:41Z
dc.date.issued2017
dc.identifier.issn2044-6055en_US
dc.identifier.doi10.1136/bmjopen-2017-017866en_US
dc.identifier.urihttp://hdl.handle.net/10072/398643
dc.description.abstractINTRODUCTION: Dental caries (tooth decay) is a common disease in which the products of sugar metabolism by certain bacteria that populate the tooth surface induce the development and progression of lesions (cavities). This is a phase II single-centre randomised, double-blind, active-controlled, parallel-group trial to assess the efficacy of a combination povidone iodine and sodium fluoride dental varnish to determine if it is superior to a varnish containing only sodium fluoride in the prevention of new caries lesions. The objective of this report is to describe the rationale and protocol for the trial. METHODS AND ANALYSIS: The study site is Pohnpei State, Federated States of Micronesia. The study population is 284 children 48-84 months old. The primary outcome will be the surface-level primary molar caries increment (d2-3mfs/DMFS) at 2 years post baseline. The incremental dental caries at 1 year will also be compared between the two interventions. The secondary outcome is the Facial Image Scale after the initial treatment and after the fifth treatment at 1 year that gauges the child's response to the treatment. ETHICS AND DISSEMINATION: The Western Institutional Review Board (designated IRB) and the Institutional Review Board of the College of Micronesia-FSM approved all study procedures. The US Food and Drug Administration (FDA) has issued IND 128835 covering this study. The study results will be published and submitted to the FDA in support of a new drug application. TRIALREGISTRATION NUMBER: NCT03082196.en_US
dc.description.peerreviewedYesen_US
dc.languageEnglishen_US
dc.language.isoeng
dc.publisherBMJ Publishing Groupen_US
dc.relation.ispartofpagefrome017866en_US
dc.relation.ispartofissue6en_US
dc.relation.ispartofjournalBMJ Openen_US
dc.relation.ispartofvolume7en_US
dc.subject.fieldofresearchClinical Sciencesen_US
dc.subject.fieldofresearchPublic Health and Health Servicesen_US
dc.subject.fieldofresearchOther Medical and Health Sciencesen_US
dc.subject.fieldofresearchcode1103en_US
dc.subject.fieldofresearchcode1117en_US
dc.subject.fieldofresearchcode1199en_US
dc.subject.keywordsScience & Technologyen_US
dc.subject.keywordsLife Sciences & Biomedicineen_US
dc.subject.keywordsMedicine, General & Internalen_US
dc.subject.keywordsGeneral & Internal Medicineen_US
dc.subject.keywordsEARLY-CHILDHOOD CARIESen_US
dc.titleEfficacy evaluation of an anti-caries varnish: protocol for a phase II randomised controlled trialen_US
dc.typeJournal articleen_US
dc.type.descriptionC1 - Articlesen_US
dcterms.bibliographicCitationMilgrom, P; Tut, O; Rothen, M; Mancl, L; Gallen, M; Tanzer, JM, Efficacy evaluation of an anti-caries varnish: protocol for a phase II randomised controlled trial, BMJ OPEN, 2017, 7, pp. e017866en_US
dcterms.licensehttp://creativecommons.org/licenses/by-nc/4.0/en_US
dc.date.updated2020-10-25T23:47:24Z
dc.description.versionVersion of Record (VoR)en_US
gro.rights.copyright© The Author(s) 2017. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/en_US
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gro.griffith.authorTut, Ohnmar


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