Award Title: 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
Funder: Public Health Agency, NI

Abstract: Unfortunately, child tooth decay is a major problem in the UK and many children end up in hospital to have teeth removed due to severe decay. We know the advice and support for parents and carers of these children on how to improve dental health is lacking. Children develop more tooth decay in the future because family routines and lifestyles do not change once the child has recovered from the operation to remove teeth. Many of these families live in deprived communities and face life challenges. Understandably, they can struggle to prioritise oral health and hygiene over other more pressing needs. Families may not be aware of the high sugar content in soft drinks and snacks consumed by their children after school, at grandparents or during weekend activities. They may also not realise the damage that snacking throughout the day can cause to their children’s teeth. _x000D_
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We plan to invite parents whose children have tooth decay to visit a local dentist so that they can meet a dental nurse trained in supporting them to change their children’s tooth brushing and dietary habits. We believe that every child should have the opportunity to grow up with a healthy mouth and a bright smile. Children who have healthy smiles have more self-esteem and confidence. This encourages and supports them to have the best possible chance to succeed in life. This study provides families with knowledge and skills to develop healthy tooth brushing habits and an understanding of how healthy eating can prevent child tooth decay._x000D_
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Here, we want to explore the benefits of a dental nurse to provide parents with supportive advice and plans, personal to them, to help prevent or reduce future tooth decay. We also want to see if dental practices are the best places to deliver this within local communities. We will identify children with at least one decayed tooth. We will then invite their parent/carer to talk with a dental nurse to learn about how best to prevent tooth decay in the future._x000D_
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The study will last up to two years. We plan to ask around 900 parents and children to take part when they attend for a dental check-up with their dentist. Half will be randomly selected to have an initial, supportive conversation with the dental nurse (lasting half an hour) while the other half will not, as they will have their usual dental care. Parents will be asked to come to the dental practice, on one occasion only, to meet with the dental nurse, fill out some questionnaires and learn about how to prevent further tooth decay in their child. The dental nurse will support parents to identify areas of their home life that can be changed and they will set goals that will achieve this. We will ask parents to set two goals of their choice. These goals will usually focus on controlling sugar in the diet and tooth brushing. We know that both can help prevent tooth decay. At the end of this visit, the child will attend the dentist as normal for their check-up. At the end of year one and two, parents will be asked to complete a questionnaire that they will get in the dental practice or by post and return to the study office. At the end of two years, children will have a dental check-up either in the dental practice or in school by the study dentist. _x000D_
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Some children may benefit from their parent/carer learning about how to prevent tooth decay, leading to less dental problems in the future. All parents who take part in the study will receive a free oral health pack for their child.

Lay Abstract: 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._x000D_
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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. _x000D_
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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._x000D_
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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._x000D_
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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. _x000D_
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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._x000D_
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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.

Research Activity Codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health Categories: ORAL AND GASTROINTESTINAL