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
Date: 2021
Persistent ID: https://hdl.handle.net/10216/149758
Origin: Repositório Aberto da Universidade do Porto
Subject(s): Aerosols; COVID-19; Children; Conservative care; Dental care; Dental caries; Multicenter study; Outcome assessment; Remote consultation
Description
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.
