{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,14]],"date-time":"2025-12-14T19:27:47Z","timestamp":1765740467187,"version":"3.48.0"},"reference-count":25,"publisher":"BMJ","issue":"6","funder":[{"DOI":"10.13039\/100000072","name":"National Institute of Dental and Craniofacial Research","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000072","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2017,6,1]]},"published-print":{"date-parts":[[2017,6]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>\n                      The study site is Pohnpei State, Federated States of Micronesia. The study population is 284 children 48\u201384\u2009months old. The primary outcome will be the surface-level primary molar caries increment (d\n                      <jats:sub>2-3<\/jats:sub>\n                      mfs\/DMFS) at 2\u2009years post baseline. The incremental dental caries at 1\u2009year 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\u2009year that gauges the child\u2019s response to the treatment.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trialregistration number<\/jats:title>\n                    <jats:p>NCT03082196.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2017-017866","type":"journal-article","created":{"date-parts":[[2017,7,17]],"date-time":"2017-07-17T14:51:31Z","timestamp":1500303091000},"page":"e017866","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":4,"title":["Efficacy evaluation of an anti-caries varnish: protocol for a phase II randomised controlled trial"],"prefix":"10.1136","volume":"7","clinical-trial-number":[{"clinical-trial-number":"nct03082196","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0784-9181","authenticated-orcid":false,"given":"Peter","family":"Milgrom","sequence":"first","affiliation":[{"name":"Department of Oral Health Sciences, School of Dentistry, University of Washington, Seattle, Washington, USA"},{"name":"Advantage Silver Dental Arrest, LLC, Redmond, Oregon, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ohnmar","family":"Tut","sequence":"additional","affiliation":[{"name":"Department of Oral Health Sciences, School of Dentistry, University of Washington, Seattle, Washington, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marilynn","family":"Rothen","sequence":"additional","affiliation":[{"name":"Department of Oral Health Sciences, School of Dentistry, University of Washington, Seattle, Washington, USA"},{"name":"Regional Clinical Dental Research Center, Institute of Translational Health Sciences, University of Washington, Seattle, Washington, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lloyd","family":"Mancl","sequence":"additional","affiliation":[{"name":"Department of Oral Health Sciences, School of Dentistry, University of Washington, Seattle, Washington, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marcelle","family":"Gallen","sequence":"additional","affiliation":[{"name":"Department of Dental Services, Pohnpei State Health Department, Kolonia, Federated States of Micronesia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jason M","family":"Tanzer","sequence":"additional","affiliation":[{"name":"Department of Oral and Maxillofacial Diagnostic Sciences, University of Connecticut Health Center, Farmington, Connecticut, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2017,6,30]]},"reference":[{"key":"2025121411250530000_7.6.e017866.1","doi-asserted-by":"publisher","DOI":"10.1186\/s12903-016-0171-6"},{"key":"2025121411250530000_7.6.e017866.2","doi-asserted-by":"publisher","DOI":"10.14219\/jada.archive.2013.0057"},{"key":"2025121411250530000_7.6.e017866.3","first-page":"E148","article-title":"Guideline on periodicity of examination, preventive dental services, anticipatory guidance\/counseling, and oral treatment for infants, children, and adolescents","volume":"35","author":"American Academy of Pediatric Dentistry","year":"2013","journal-title":"Pediatr Dent"},{"key":"2025121411250530000_7.6.e017866.4","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2014-0483"},{"key":"2025121411250530000_7.6.e017866.5","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2013-3501"},{"key":"2025121411250530000_7.6.e017866.6","doi-asserted-by":"publisher","DOI":"10.1016\/j.acap.2009.09.001"},{"key":"2025121411250530000_7.6.e017866.7","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/dkl085"},{"key":"2025121411250530000_7.6.e017866.8","doi-asserted-by":"crossref","first-page":"391","DOI":"10.1111\/j.1399-302X.2008.00441.x","article-title":"Effect of antiplaque compounds and mouthrinses on the activity of glucosyltransferases from Streptococcus sobrinus and insoluble glucan production","volume":"23","author":"Furiga","year":"2008","journal-title":"Oral Microbiol Immunol"},{"key":"2025121411250530000_7.6.e017866.9","doi-asserted-by":"publisher","DOI":"10.1177\/00220345790580040301"},{"key":"2025121411250530000_7.6.e017866.10","doi-asserted-by":"publisher","DOI":"10.1111\/j.1752-7325.2006.tb02576.x"},{"key":"2025121411250530000_7.6.e017866.11","doi-asserted-by":"publisher","DOI":"10.1111\/j.1752-7325.2009.00118.x"},{"key":"2025121411250530000_7.6.e017866.12","first-page":"204","article-title":"Topical antimicrobial therapy in the prevention of early childhood caries: a follow-up report","volume":"24","author":"Lopez","year":"2002","journal-title":"Pediatr Dent"},{"key":"2025121411250530000_7.6.e017866.13","first-page":"5","article-title":"Effect of povidone-iodine on Streptococcus mutans in children with extensive dental caries","volume":"26","author":"Amin","year":"2004","journal-title":"Pediatr Dent"},{"key":"2025121411250530000_7.6.e017866.14","doi-asserted-by":"crossref","first-page":"249","DOI":"10.1111\/j.1752-7325.2010.00163.x","article-title":"Topical iodine and fluoride varnish combined is more effective than fluoride varnish alone for protecting erupting first permanent molars: a retrospective cohort study","volume":"70","author":"Tut","year":"2010","journal-title":"J Public Health Dent"},{"key":"2025121411250530000_7.6.e017866.15","first-page":"143","article-title":"Topical iodine and fluoride varnish effectiveness in the primary dentition: a quasi-experimental study","volume":"78","author":"Milgrom","year":"2011","journal-title":"J Dent Child"},{"key":"2025121411250530000_7.6.e017866.16","doi-asserted-by":"crossref","first-page":"47","DOI":"10.1046\/j.0960-7439.2001.00322.x","article-title":"Validation of a Facial image Scale to assess child dental anxiety","volume":"12","author":"Buchanan","year":"2002","journal-title":"Int J Paediatr Dent"},{"key":"2025121411250530000_7.6.e017866.17","first-page":"27","article-title":"Cluster-randomized xylitol toothpaste trial for early childhood caries prevention","volume":"81","author":"Chi","year":"2014","journal-title":"J Dent Child"},{"key":"2025121411250530000_7.6.e017866.18","doi-asserted-by":"publisher","DOI":"10.2307\/2684968"},{"key":"2025121411250530000_7.6.e017866.19","unstructured":". R package version 1.1-3. 2015. https:\/\/CRAN.R-project.org\/package=pwr (Accessed on December 1, 2016)."},{"key":"2025121411250530000_7.6.e017866.20","doi-asserted-by":"crossref","unstructured":"Schafer JL . Analysis of Incomplete Multivariate Data. New York, NY. USA: BMJ Publishing Group, 1997.","DOI":"10.1201\/9781439821862"},{"key":"2025121411250530000_7.6.e017866.21","doi-asserted-by":"crossref","unstructured":"Hardin JW , Hilbe JM . Chapman and Hall\/CRC. Generalized Estimating Equations. New York, 2003.","DOI":"10.1201\/9781420035285"},{"key":"2025121411250530000_7.6.e017866.22","doi-asserted-by":"crossref","first-page":"353","DOI":"10.1128\/mr.50.4.353-380.1986","article-title":"Role of Streptococcus mutans in human dental decay","volume":"50","author":"Loesche","year":"1986","journal-title":"Microbiol Rev"},{"key":"2025121411250530000_7.6.e017866.23","doi-asserted-by":"crossref","first-page":"1028","DOI":"10.1002\/j.0022-0337.2001.65.10.tb03446.x","article-title":"The microbiology of primary dental caries in humans","volume":"65","author":"Tanzer","year":"2001","journal-title":"J Dent Educ"},{"key":"2025121411250530000_7.6.e017866.24","unstructured":"\u00a0U.S. Department of Health and Human Services (USDHHS). Oral Health in America: A Report of theSurgeon General. Rockville, MD: BMJ Publishing Group, 2000."},{"key":"2025121411250530000_7.6.e017866.25","doi-asserted-by":"publisher","DOI":"10.1159\/000264686"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2017-017866","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,14]],"date-time":"2025-12-14T19:25:14Z","timestamp":1765740314000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2017-017866"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017,6]]},"references-count":25,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2017,6,30]]},"published-print":{"date-parts":[[2017,6]]}},"alternative-id":["10.1136\/bmjopen-2017-017866"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2017-017866","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"type":"print","value":"2044-6055"},{"type":"electronic","value":"2044-6055"}],"subject":[],"published":{"date-parts":[[2017,6]]}}}