Minimally invasive dentistry based on atraumatic restorative treatment to manage early childhood caries in rural and remote Aboriginal communities: protocol for a randomized controlled trial

BACKGROUND: The caries experience of Aboriginal children in Western Australia (WA) and elsewhere in Australia is more than twice that of non-Aboriginal children. Early childhood caries (caries among children <6 years) has a significant impact on the quality of life of children and their caregivers, and its management is demanding and commonly undertaken under general anesthesia. A randomized controlled trial using a minimally invasive dentistry approach based on Atraumatic Restorative Treatment (ART) in metropolitan Perth, WA, has demonstrated a significant reduction in the rate of referral to a dental specialist for dental care among children with early childhood caries, potentially reducing the need for treatment under general anesthesia. The tested approach was clinically successful and was without adverse effects on child dental anxiety. The model of ART-based primary care requires further testing and development if similar outcomes for Aboriginal children in remote and rural settings are to be achieved. OBJECTIVE: The study aims to develop, implement, and evaluate a remote primary care model to deliver effective primary dental services, encompassing treatment and preventive services, to Aboriginal preschool children (based on minimally invasive approaches including ART). METHODS: This is a two-arm parallel cluster randomized controlled study in which a test group will be provided with the intervention treatment at the start of the study and a control group will be provided with the intervention treatment 12 months after study commencement (delayed intervention). Participating communities, stratified by size of community (ie, number of children in the sample frame) and baseline caries experience, will be randomly assigned using a computer-generated block randomized list into immediate (test group) or delayed intervention (control group; provided with standard care). Informed consent will be obtained from all participants. Aboriginal research assistants will explain the study to the parents and assist the parents in completing the questionnaires. Participants in the randomized study will be examined at baseline and at 12 months follow-up by a calibrated examiner. Test group participants will subsequently be contacted and appropriate appointments coordinated for treatment. Control group participants will be provided with standard preventive care by the Aboriginal Health Workers and managed for treatment as per standard procedures. RESULTS: Community consultations have been undertaken and 26 communities have agreed to participate. Fieldwork is in progress to recruit study participants. CONCLUSIONS: The significance of the study lies in its holistic approach to testing the model of care. Clinical evaluations as well as oral health‒related quality of life evaluations will be undertaken. Cost-effectiveness and cost-utility evaluations will assist in the development of policy options for oral health services for rural and remote communities. The elicitation of caregiver perspectives through focus group interviews will supplement the clinical, psychosocial, and cost-utility evaluations and provide a richer evaluation of the intervention. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12616001537448; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371735 (Archived by WebCite at http://www.webcitation.org/70UMxndFZ). REGISTERED REPORT IDENTIFIER: RR1-10.2196/10322.