{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,26]],"date-time":"2026-06-26T17:56:00Z","timestamp":1782496560496,"version":"3.54.5"},"reference-count":42,"publisher":"BMJ","issue":"2","license":[{"start":{"date-parts":[[2026,2,12]],"date-time":"2026-02-12T00:00:00Z","timestamp":1770854400000},"content-version":"unspecified","delay-in-days":11,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100005916","name":"Universidad de La Frontera","doi-asserted-by":"publisher","award":["DI19-0091"],"award-info":[{"award-number":["DI19-0091"]}],"id":[{"id":"10.13039\/501100005916","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2025,12,18]]},"published-print":{"date-parts":[[2026,2]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Early childhood caries (ECC) continues to be a public health problem. The application of silver diamine fluoride (SDF) is a simple, non-invasive procedure. This study aims to evaluate SDF\u2019s effectiveness, acceptability and oral health-related quality of life (OHRQoL) compared with atraumatic restorative treatment in managing ECC.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>An open-label parallel superiority randomised clinical trial will be conducted involving children aged 2\u20135 years. Participants will include children with at least one active cavitated lesion (ICDAS 5+) of their primary teeth, with no signs of pulp involvement. The trial will occur at preschools in the La Araucan\u00eda and Metropolitan Regions of Chile from 2025 to 2027. The primary outcome variable will be the caries lesion arrest, acceptability and OHRQoL. We will also determine the presence of any adverse effects. Evaluations will be carried out at 6 and 12 months. A sample of 234 teeth with carious lesions per group is estimated. The primary inferential analysis will be performed on an intention-to-treat basis; a per-protocol analysis will be conducted for adverse effects. For caries lesion arrest, a multilevel logistic regression model adjusted for significant covariates will be used to account for within-child clustering. The acceptability will be assessed through quantitative and qualitative methods. The magnitude of change in OHRQoL between baseline and follow-up will be quantified using effect size estimates derived from the early childhood health impact scale survey data.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>This study\u2019s implementation benefits the study population, and the ethical principles of research have been considered and approved by the Science Committee of the University, Resolution N\u00b0049_19. The results and conclusions of the clinical trial will be published in academic conferences and peer-reviewed journals.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT06786975\">NCT06786975<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-106271","type":"journal-article","created":{"date-parts":[[2026,2,13]],"date-time":"2026-02-13T07:25:12Z","timestamp":1770967512000},"page":"e106271","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Effectiveness, acceptability and oral health-related quality of life of silver diamine fluoride compared with atraumatic restorative treatment for the management of early childhood caries: protocol of a pragmatic randomised clinical trial"],"prefix":"10.1136","volume":"16","clinical-trial-number":[{"clinical-trial-number":"nct06786975","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct06786975","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct06786975","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Patricia","family":"Mu\u00f1oz Mill\u00e1n","sequence":"first","affiliation":[{"name":"Department of Pediatric Dentistry and Orthodontics, Universidad de La Frontera, Temuco, Chile"},{"name":"Center for Research in Epidemiology, Economics and Oral Public Health(CIEESPO), Faculty of Dentistry, Universidad de La Frontera, Temuco, Chile"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patricia","family":"Pineda","sequence":"additional","affiliation":[{"name":"Department of Pediatric Dentistry and Orthodontics, Universidad de La Frontera, Temuco, Chile"},{"name":"Center for Research in Epidemiology, Economics and Oral Public Health(CIEESPO), Faculty of Dentistry, Universidad de La Frontera, Temuco, Chile"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Margherita","family":"Fontana","sequence":"additional","affiliation":[{"name":"Department of Cariology, Restorative Science and Endodontics, University of Michigan School of Dentistry, Ann Arbor, MI, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vicente Ar\u00e1nguiz","family":"Freyhofer","sequence":"additional","affiliation":[{"name":"Faculty of Dentistry, Universidad de Los Andes, Santiago, Chile"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Orme\u00f1o","sequence":"additional","affiliation":[{"name":"Faculty of Dentistry, Universidad de Los Andes, Santiago, Chile"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katalina","family":"Mu\u00f1oz","sequence":"additional","affiliation":[{"name":"Center for Research in Epidemiology, Economics and Oral Public Health(CIEESPO), Faculty of Dentistry, Universidad de La Frontera, Temuco, Chile"},{"name":"Master's Program in Odontology, Faculty of Dentistry, Universidad de La Frontera, Temuco, Chile"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5836-1138","authenticated-orcid":false,"given":"Mar\u00eda Jos\u00e9","family":"Martinez-Zapata","sequence":"additional","affiliation":[{"name":"Iberoamerican Cochrane Centre-Clinical Epidemiology and Public Health Service. 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