How did CariesCare International performed under pandemic conditions in children: 1-year multicenter single-group interventional study
Authors: Martignon Stefania , Beltrán Edgar O. , Douglas Gail V. A. , Newton J. Timothy , Pitts Nigel B. , Deery Christopher , Carletto‐Körber Fabiana P. M. , Cifuentes Olga L. , Fortich Natalia , Chavarria Nathaly , Echeverri Beatriz , Kuzmina Irina , Muller‐Bolla Michèle , Osorio Jesús R. , Ramos Ketty , Sanjuán Johanna , San-Martín Magdalena , Squassi Aldo , Villena Rita , Aïem Elody , Cáceres-Matta Sandra , Carreño Laura Marcela , Cerezo María P. , Conrado Adriana , Hermida Laura , Llamas José Ignacio , Oña Jennifer A. , Sanabria Angie , Said Daria , Sarrazola Angela , Sorazabal Ana , Zelada Diana , Abreu‐Placeres Ninoska , Braga Mariana M. , Lara J. Sebastián , Melo Paulo , Areias Cristina , de Luca Ana Clara Falabello , Tello Alejandra Rubi , Yunes-Fragoso Paula , Martinez-Mier E Angeles , Zandona Andrea Ferreira , Cortes Andrea 
Published: February 2024

Abstract
Background:In 2020, CariesCare International (CCI) -derived from ICCMS- was plannedto be tested for caries-control effectiveness in children by means of a multicenter randomized clinical trial (RCT). Nevertheless, due to the pandemic, RCTs proved unfeasible and aerosol-generating procedures (AGP) were associated with a spread of COVID-19. Consequently, the study design required to be modified to a single-interventional study and CCI had to be adapted excluding AGP and reducing on-site consultation (CCI-adapted).
Objective: This 12-month multicenter single-group interventional study aimed at assessing the effect of a pandemic CCI-adapted protocol on caries control in children.
Methods: Twenty-one Latin American and European centers with n³20 3-8-year-old children per center were invited to participate; 17 obtained IRB and signed written informed consents. Trained examiners assessed at baseline (T0) and 1-year follow-up (T1y) (blind to the intervention): CCI-caries risk, oral-health-related practices; dmf/DMFS with ICDAS-merged-Epi visual caries severity and activity criteria; dental sepsis and toothache. Individual- and tooth-surface-level personalized care plan was then performed by dental practitioners previously trained in CCI-adapted. After 5 months, parents’ and dentists’ dental-care-process acceptance (Treatment Evaluation Inventory) was assessed. The one-year caries-control effect of CCI-adapted was assessed in terms of tooth-surface and individual-level caries-progression control; oral-health behavior improvement, and caries-care system acceptability.
Results: Sixteen centers finished the study (94.1%; Latin America: n=13; Europe: n=3), with 337 children (78.6%;mean age of 5.5±1.6 years). There was a T0 to T1y significant decrease (p<0.05) in the mean number of tooth surfaces with caries lesions (7.7±9.1 to 2.8±4.6), with active caries lesions (6.8±8.8 to 0.8±2.2), and a tooth-surface caries-progression control of 99.3%. In the majority of children there was a significant (p<0.05) control of: caries progression (79.5%), high-caries risk (86.6%), and non-adequate oral-health behavior (72.7%). There was a very high (parents) and a high-very high (dentists) acceptability of CCI.
Conclusion: Given the challenge of the pandemic, this single-group interventional CCI-adapted study showed one-year control of caries progression, caries risk, and high parents’ and dentists’ CCI acceptance.
Trial registration:Retrospectively‐registered‐ClinicalTrials.gov NCT04666597 07/12/2020 (Protocol version 2): https://register.clinicaltrials. gov/prs/app/action/SelectProtocol?sid=S000AGM4&selectaction=Edit&uid=U00019IE&ts=2&cx=uwje3h