Please use this identifier to cite or link to this item:
https://hdl.handle.net/10216/149758
Author(s): | Martignon, S Cortes, A Douglas, GVA Newton, JT Pitts, NB Avila, V Usuga-Vacca, M Gamboa, LF Deery, C Abreu-Placeres, N Bonifacio, C Braga, MM Carletto-Körber, F Castro, P Cerezo, MP Chavarría, N Cifuentes, OL Echeverri, B Jácome-Liévano, S Kuzmina, I Lara, JS Manton, D Martínez-Mier, EA Melo, P Muller-Bolla, M Ochoa, E Osorio, JR Ramos, K Sanabria, AF Sanjuán, J San-Martín, M Squassi, A Velasco, AK Villena, R Zandona, AF Beltrán, EO |
Title: | CariesCare International adapted for the pandemic in children: Caries OUT multicentre single-group interventional study protocol |
Publisher: | BMC |
Issue Date: | 2021 |
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. |
Subject: | Aerosols COVID-19 Children Conservative care Dental care Dental caries Multicenter study Outcome assessment Remote consultation |
URI: | https://hdl.handle.net/10216/149758 |
Source: | BMC Oral Health. 2021 Jul 1;21(1):329 |
Document Type: | Outra Publicação em Revista Científica Internacional |
Rights: | openAccess |
License: | https://creativecommons.org/licenses/by/4.0/ |
Appears in Collections: | ISPUP - Outra Publicação em Revista Científica Internacional |
Files in This Item:
File | Description | Size | Format | |
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martignon-bmcoh-2021.pdf | 4.97 MB | Adobe PDF | View/Open |
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