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CariesCare International adapted for the pandemic in children: Caries OUT multicentre single-group interventional study protocol

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Stefania Martignon, Andrea Cortes, Gail V A Douglas, J Timothy Newton, Nigel B Pitts, Viviana Avila, Margarita Usuga-Vacca, Luis F Gamboa, Christopher Deery, Ninoska Abreu-Placeres, Clarisa Bonifacio, Mariana M Braga, Fabiana Carletto-Körber, Patricia Castro, María P Cerezo, Nathaly Chavarría, Olga L Cifuentes, Beatriz Echeverri, Sofía Jácome-Liévano, Irina Kuzmina & 16 more J Sebastián Lara, David Manton, E Angeles Martínez-Mier, Paulo Melo, Michèle Muller-Bolla, Emilia Ochoa, Jesús R Osorio, Ketty Ramos, Angie F Sanabria, Johanna Sanjuán, Magdalena San-Martín, Aldo Squassi, A Karina Velasco, Rita Villena, Andrea Ferreira Zandona, Edgar O Beltrán

Original languageEnglish
Article number329
Pages (from-to)329
JournalBMC Oral Health
Volume21
Issue number1
DOIs
PublishedDec 2021

Bibliographical note

Funding Information: Acknowledgements to the International Association for Dental Research Regional Development Program Latin American Region (IADR RDP LAR), the participating centres with their dental teams, the Colombian Chapter of the Alliance for a Cavity Free Future (CC-ACF), the Colombian Ministry of Science, Technology and Innovation (MinCiencias), the Global Collaboratory for Caries Management (GCCM) at King?s College London, and CariesCare International (CCI?). Funding Information: Part of this project will be funded by a grant from the IADR’s Regional Development Program—Latin American Region (IADR RDP LAR) (June 24th 2020). The centres located within the IADR Latin American Region countries will participate of this partial funding (Argentina, Brazil, Colombia, Dominican Republic, Perú, Uruguay). The IADR RDP LAR representatives have reviewed a general proposal of the study. The funding of IADR’s RDP LAR is only intended for strengthening of the collaborative network with the IADR LAR Divisions/Sections, contributing in the development of research skills of researchers, institutions and IADR Divisions/Sections. IADR’s RDP LAR does not have authority in any of the following: study design, collection, management, analysis, and interpretation of data; writing of the report; the decision to submit the report for publication. Publisher Copyright: © 2021, The Author(s). Copyright: Copyright 2021 Elsevier B.V., All rights reserved.

King's Authors

Abstract

BACKGROUND: 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™ for the practice (2019), remains unproven. With the onset of the COVID-19 pandemic a previously planned multi-centre RCT shifted to this "Caries OUT" 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.

METHODS: 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's oral-health behaviour change, parents' and dentists' process acceptability, and costs exploration. A sample size of 258 3-5 and 6-8 years 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' time. A trained examiner per centre will conduct examinations at baseline, at 5-5.5 months (3 months after basic management), 8.5 and 12 months, assessing the child's 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' and dentists' 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.

DISCUSSION: 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.

TRIAL REGISTRATION: Retrospectively-registered-ClinicalTrials.gov-NCT04666597-07/12/2020: https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S000AGM4&selectaction=Edit&uid=U00019IE&ts=2&cx=uwje3h . Protocol-version 2: 27/01/2021.

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