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