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

Abstract Background Comprehensive caries care has shown effectiveness in controlling progression and improving health outcomes by risk, preventing initial-caries lesions progression, patient satisfaction. To date, the caries-progression control of patient-centred risk-based CariesCare International (CCI) system, derived from ICCMS™ for practice (2019), remains unproven. With onset COVID-19 pandemic a previously planned multi-centre RCT shifted to this “Caries OUT” study, aiming assess single-intervention group children, caries-control CCI adapted with non-aerosols generating procedures (non-AGP) reducing in-office time. Methods In 1-year single-group interventional trial adapted-CCI will be assessed one single terms tooth-surface level control, secondarily, individual-level children’s oral-health behaviour change, parents’ dentists’ process acceptability, costs exploration. A sample size 258 3–5 6–8 years old patients was calculated after removing half previous RCT, allowing 25% dropout, including generally children (27 per centre). The intervention 4D-cycle care, non-AGP reduced appointments’ trained examiner centre conduct examinations at baseline, 5–5.5 months (3 basic management), 8.5 12 months, assessing child’s risk behaviour, visually staging caries-lesions severity activity without air-drying (ICDAS-merged Epi); fillings/sealants; missing/dental-sepsis teeth, tooth symptoms, synthetizing together parent external-trained dental practitioner (DP) patient- diagnoses personalised plan. DP deliver care. Parents’ acceptability via Treatment-Evaluation-Inventory questionnaires, number appointments activities. Twenty-one centres 13 countries participate. Discussion results Caries OUT provide clinical data that could help support shifting towards individualised improvement tooth-preserving outcomes, explore if can controlled during conducting 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.