CHOICE TRIAL: Changing Habits tO Prevent ChIld CariEs: A Randomized Controlled Trial of a Family-Focused Therapeutic Conversation Delivered by Dental Nurses in Primary Care

BACKGROUND: Child dental caries remains a significant problem in the UK, with high prevalence in deprived communities. The CHOICE Trial builds on the successful Dental RECUR Trial conducted in secondary care, which showed a significant benefit of the DR-BNI (Dental Recur – Brief Negotiated Interview) intervention for children scheduled for extractions. DR-BNI uses a personalised goal-centred approach to teach parents/guardians how to change habits that lead to tooth decay in favour of health promoting family routines. CHOICE Trial delivers DR-BNI in primary dental care, allowing evaluation of its effectiveness in high risk children at a much earlier stage of the disease. AIM: The aim of the trial is to evaluate the effectiveness and cost-effectiveness in NHS primary care of DR-BNI and usual care versus usual care alone, to prevent dental caries in children. PRIMARY OBJECTIVES: Compare the primary outcome (dental caries 2 years’ post-randomisation on any tooth which was caries free or unerupted at baseline) between DR-BNI and usual care versus usual care alone. Compare costs and benefits of DR-BNI and usual care with usual care alone within a cost effectiveness framework. SECONDARY OBJECTIVES include comparisons of secondary outcomes, taking account of episodes of dental pain, number of fillings and extractions, and reported oral health behaviours, process evaluation, and exploration of potential mediators (parental self-efficacy and regret/relief) of the effect of intervention on outcome. METHODS: 908 children aged 3 to 7 years with at least one decayed tooth, but who do not require dental extractions will be recruited from approximately 40 dental practices in four regions of the UK, and randomised 1:1 to either DR-BNI and usual care, or usual care only. The first 6 months of recruitment will form an internal pilot with stop/go targets. Dental nurses within practices will be trained to deliver the 30-minute intervention based on behaviour change theory and delivered using Motivational Interviewing. Baseline and intermediate clinical data (one year following delivery of the DR-BNI intervention) will be collected from dental practices. Parent reported outcomes will be collected at practices, or by post/telephone if participants do not attend. The primary outcome dental assessment at 2 years will be carried out for all participants by a single trained dentist, either at schools or dental practices. Audio recordings of DR-BNI sessions will be analysed for fidelity and dose using established protocols. TIMELINES FOR DELIVERY: The study will last 54 months including 6 months setup, 18 months recruitment, 24 months follow-up and 6 months analysis and reporting. Participants will remain in the study for two years. ANTICIPATED IMPACT AND DISSEMINATION: Academic outputs will include protocol publication, HTA monograph, and articles both in high impact journals, and publications with wide readership by dental practitioners. Lay summaries and social media campaigns will be used to disseminate to at risk communities. A commissioning policy group will be set up co-chaired by the PPI lead, and results presented and discussed with policy makers in all four UK countries. If effective in primary care, a resource for General Dental Practices to deliver a dental nurse-led motivational interviewing intervention to contribute to an effective caries prevention programme will be made widely available across the UK.