Objectives:The management of early childhood caries is challenging and the impacts of its treatment on child oral health-related quality of life (COHRQoL) and dental anxiety among Australian Aboriginal children is relatively unknown. The aim of the study was to compare the impact on COHRQoL and dental anxiety after approximately 12 months among Aboriginal children treated for early childhood caries (ECC) using the Atraumatic Restorative Treatment and the Hall Technique (ART/HT: test) or standard care (control).Methods: Consenting Aboriginal communities in the North-West of Western Australia were randomized into early (test) or delayed (control) intervention for the management of ECC. Children and parents/carers completed a questionnaire at baseline and at follow-up. The questionnaire sought information on COHRQoL using the proxyreported Early Childhood Oral Health Impact Scale (ECOHIS) and the self-reported Caries Impacts and Experiences Questionnaire for Children (CARIES-QC). The test group was provided with the ART/HT care at baseline while the control group was advised to seek care through the usual care options available within the community. At follow-up, both groups were offered care using the ART/HT approach. Changes in the mean scores from baseline to follow-up within groups were evaluated using appropriate paired (t-test, Wilcoxon paired test), and between groups with unpaired tests (ttest). Multivariate regression analysis after multiple imputations of missing data used generalized estimating equation (GEE) controlling for clustering within communities.Results: Twenty-five communities and 338 children (mean age = 3.6 years, sd 1.7) participated in the study (test = 177). One child was excluded from the analysis because of a missing questionnaire and clinical data at baseline and follow-up. At baseline, test group children were older (test = 3.8 years, 95% CI 3.6-4.1;control = 3.3 years, 95% CI 3.1-3.6) and had higher caries experience (test dmft = 4.4, 95% CI 3.8-5.0;control dmft = 3.1, 95% CI 2.5-3.7), but there was no significant difference in COHRQoL or
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