{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,8]],"date-time":"2026-04-08T16:47:09Z","timestamp":1775666829249,"version":"3.50.1"},"reference-count":49,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2021,7,1]],"date-time":"2021-07-01T00:00:00Z","timestamp":1625097600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2021,7,1]],"date-time":"2021-07-01T00:00:00Z","timestamp":1625097600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"IADR Regional Development Program - Latin American Region"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Oral Health"],"published-print":{"date-parts":[[2021,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>Comprehensive caries care has shown effectiveness in controlling caries progression and improving health outcomes by controlling caries risk, preventing initial-caries lesions progression, and patient satisfaction. To date, the caries-progression control effectiveness of the patient-centred risk-based CariesCare International (CCI) system, derived from ICCMS\u2122 for the practice (2019), remains unproven. With the onset of the COVID-19 pandemic a previously planned multi-centre RCT shifted to this \u201cCaries OUT\u201d study, aiming to assess in a single-intervention group in children, the caries-control effectiveness of CCI adapted for the pandemic with non-aerosols generating procedures (non-AGP) and reducing in-office time.\n<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>In this 1-year multi-centre single-group interventional trial the adapted-CCI effectiveness will be assessed in one single group in terms of tooth-surface level caries progression control, and secondarily, individual-level caries progression control, children\u2019s oral-health behaviour change, parents\u2019 and dentists\u2019 process acceptability, and costs exploration. A sample size of 258 3\u20135 and 6\u20138\u00a0years old patients was calculated after removing half from the previous RCT, allowing for a 25% dropout, including generally health children (27 per centre). The single-group intervention will be the adapted-CCI 4D-cycle caries care, with non-AGP and reduced in-office appointments\u2019 time. A trained examiner per centre will conduct examinations at baseline, at 5\u20135.5\u00a0months (3\u00a0months after basic management), 8.5 and 12\u00a0months, assessing the child\u2019s CCI caries risk and oral-health behaviour, visually staging and assessing caries-lesions severity and activity without air-drying (ICDAS-merged Epi); fillings\/sealants; missing\/dental-sepsis teeth, and tooth symptoms, synthetizing together with parent and external-trained dental practitioner (DP) the patient- and tooth-surface level diagnoses and personalised care plan. DP will deliver the adapted-CCI caries care. Parents\u2019 and dentists\u2019 process acceptability will be assessed via Treatment-Evaluation-Inventory questionnaires, and costs in terms of number of appointments and activities. Twenty-one centres in 13 countries will participate.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Discussion<\/jats:title>\n                <jats:p>The results of Caries OUT adapted for the pandemic will provide clinical data that could help support shifting the caries care in children towards individualised oral-health behaviour improvement and tooth-preserving care, improving health outcomes, and explore if the caries progression can be controlled during the pandemic by conducting non-AGP and reducing in-office time.<\/jats:p>\n                <jats:p><jats:italic>Trial registration<\/jats:italic>: Retrospectively-registered-ClinicalTrials.gov-NCT04666597-07\/12\/2020: <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/register.clinicaltrials.gov\/prs\/app\/action\/SelectProtocol?sid=S000AGM4&amp;selectaction=Edit&amp;uid=U00019IE&amp;ts=2&amp;cx=uwje3h\">https:\/\/register.clinicaltrials.gov\/prs\/app\/action\/SelectProtocol?sid=S000AGM4&amp;selectaction=Edit&amp;uid=U00019IE&amp;ts=2&amp;cx=uwje3h<\/jats:ext-link>. Protocol-version 2: 27\/01\/2021.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12903-021-01674-1","type":"journal-article","created":{"date-parts":[[2021,7,1]],"date-time":"2021-07-01T20:03:07Z","timestamp":1625169787000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["CariesCare International adapted for the pandemic in children: Caries OUT multicentre single-group interventional study protocol"],"prefix":"10.1186","volume":"21","clinical-trial-number":[{"clinical-trial-number":"nct04666597","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6505-8356","authenticated-orcid":false,"given":"Stefania","family":"Martignon","sequence":"first","affiliation":[]},{"given":"Andrea","family":"Cortes","sequence":"additional","affiliation":[]},{"given":"Gail V. A.","family":"Douglas","sequence":"additional","affiliation":[]},{"given":"J. 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The corresponding written consent form (Additional file ) and assent form (Additional file ) will be signed by parents and\/or children (in countries and ages that require it). A total of 21 centres, 20 dental schools and one health provider, will be included in this study: seven in Colombia (Universidad El Bosque, Corporaci\u00f3n Universitaria Rafael N\u00fa\u00f1ez, Fundaci\u00f3n Universitaria de Colegios de Colombia UNICOC Bogot\u00e1, Universidad Aut\u00f3noma de Manizales, Universidad Cooperativa de Colombia Envigado, Universidad de Cartagena, Viva 1A IPS Barranquilla), two in Argentina (Universidad de Buenos Aires, Universidad Nacional de C\u00f3rdoba), two in the USA (Indiana University, Tufts University), and one each in Brazil (University of Sao Paulo), Dominican Republic (Universidad Iberoamericamericana UNIBE), France (Universite Cote d\u2019 Azur), M\u00e9xico (Universidad de Guadalajara), Per\u00fa (Universidad San Mart\u00edn de Porres), Portugal (University of Porto), the Netherlands (ACTA), Russia (Moscow State University of Medicine and Dentistry), United Kingdom UK (The University of Sheffield), and Uruguay (Universidad Cat\u00f3lica de Uruguay). Study organisational frame (Fig.\u00a0): The Study Steering Committee (SM, AC, GD, TN, NP, VA, MUV, LFG, CD, EB) is in charge of monitoring and communicating with all centres, and of general project oversight. The Coordinating Centre\u2013CC (SM, AC, EB) is in UNICA at Universidad El Bosque and its role is helping coordinating the study from its start to its completion. The Endpoint Adjudication Committee (SM, AC, VA, EB) is in charge of managing the adjudication specific process during the whole study. The Data Management Team-DMT (SM, AC, VA, LFG, EB) is responsible for the overall data management collected from all centres. This will report to the Study Steering Committee and it is independent from the sponsor. The Local Centres Leaders\u2019 Committee is composed by the centres\u2019 coordinators together with the representatives of the CC (SM, AC, CD, NAP, CB, MB, FC, PC, MPC, NC, IK, JSL, EAMM, PM, MMB, EO, JRO, KR, JS, MSM, AS, RV, AFZ, EB). The assessment\/reassessments and care data will be recorded by examiners and dental practitioner\/s. Data will be kept anonymous. Patients will be identified by a number assigned for each patient and their care centre.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"329"}}