Title: HARMONY – HeAlthieR sMiles fOr childreN with cleft bY improving tooth decay prevention and management
Funder: Department of Health and Social Care

Abstract: Research question What is the best way to prevent and manage early childhood caries (ECC) in children with a cleft lip and/or palate (CLP)? Background 'The cleft team refer to general dentistry, general dentistry refers back to the cleft team, and actually the person is caught in the middle of that' this was the prevailing message when undertaking Public and Patient Involvement focus groups. Children with a CLP are more likely to develop ECC than children without a CLP, this is thought to be due to defects in tooth development for children with CLP and the increased time for food to clear the mouth. In 1998 the Clinical Standards Advisory Group reported that cleft care in the United Kingdom, fell below European counterparts and recommended reorganisation of cleft services. In 2015 the Cleft Care UK study reported, since reorganisation there had been no demonstrable improvement in ECC in children with CLP, despite most other outcomes including speech and facial appearance improving. NHS England expects dental care to be shared between primary care and paediatric dentists on the cleft team, however the effectiveness of this arrangement is unclear. Aims and objectives Aim: To identify clearly the factors contributing to, and those that might address, high levels of ECC in children with CLP, to inform the co-production of a complex intervention to improve the prevention and management of ECC in this population Objectives: 1. To conduct an observational study to identify ECC prevalence in children between 18 months and 5-years of age with CLP and identify risk factors for ECC development and predictors for its management 2. To conduct an overview of systematic reviews on interventions to prevent and manage ECC in all children 3. To explore, through qualitative enquiry, patients' and key stakeholders' views on facilitators and barriers to preventing and managing ECC in children with CLP 4. To use theory-driven intervention design frameworks to co-produce recommendations for a complex intervention to improve the prevention and management of ECC in children with CLP Methods This is a mixed-methods study comprised of four interlinked work streams. WS1 is an epidemiological analysis of the Cleft Collective cohort to investigate ECC prevalence and identify risk factors for ECC development and management. WS2 is an overview of reviews into interventions to prevent and manage ECC in all children. WS3 is a qualitative enquiry of the facilitators and barriers to children with CLP developing ECC and accessing care, involving patients and relevant stakeholders. WS4 will be a theory driven co-production study, synthesising findings from WS1-3 to develop recommendations for a complex intervention that aims to improve the prevention and management of ECC in children with CLP. Anticipated impact and dissemination The main output will be recommendations for a complex intervention co-produced by relevant stakeholders and patients that can undergo feasibility testing in future work to benefit patients, their families, and the NHS. Findings will be disseminated at conferences, published in academic journals, and shared with the public and patients via lay summaries and public engagement events.

Lay abstract: TitleHARMONY - HeAlthieR sMiles fOr childreN with cleft bY improving tooth decay prevention and managementAimTo understand why children who have a cleft are likely to develop tooth decay, to explore patients' and dentists' views on why children with a cleft struggle to get the right care in the right place, and to co-produce recommendations for an intervention which aims to improve the prevention and management of tooth decay for children with a cleft.Background 1 in 700 children are born with a cleft in the United Kingdom (UK) each year. A cleft can cause issues with speech, facial growth and teeth. Tooth decay is preventable, but children aged 5 with a cleft are at an increased risk of developing it. This is thought to be due to children with a cleft: having a high risk for developing malformed teeth which are difficult to clean having difficulty brushing around the cleft siteTreatment for decay in young children often includes removing teeth under general anaesthetic (GA). This is expensive, costing 799 for each GA. Children with a cleft will undergo many surgeries as part of their cleft treatment. Preventing the need for additional operations to treat decay will benefit children with a cleft, their parents, and the NHS.In 1998 a government report: identified children at age 5 with a cleft in the UK had worse outcomes compared to European children recommended the reorganisation of cleft services including centralisation of care to be delivered in 11 specialised services compared to 57 hospitals recommended a paediatric specialist dentist leads the dental care for children with a cleftThe Cleft Care UK study in 2015 reported that since this reorganisation: the majority of cleft related outcomes including facial appearance and speech had improved the number of children at age 5 with a cleft and decay had not changed since 1998NHS England expects the dental care for children with a cleft to be shared between the cleft team paediatric dentist and general dentists in primary care. From our work discussing this issue with patients, it appears that there is a sense of confusion about who should provide dental care and a feeling that the current arrangement is ineffective.Design and MethodsThis research study will be split into four parts: Part 1 will study data from the Cleft Collective, a large study of children with cleft, to report how common decay is and investigate risk factors for its development and treatment. Part 2 will summarise scientific evidence about existing treatments used to prevent and manage decay in all children. Part 3 will include interviews with patients, general dentists, and paediatric dentists, to understand reasons for what currently does and does not work. Part 4 will be a workshop with patients and dentists to co-produce recommendations for ways to improve the prevention and treatment of decay in children with a cleftPatient and Public InvolvementPatients and the public were involved in: designing the research question providing advice on the design of this study reviewing this applicationPatients and the public will be: reimbursed and supported to contribute to the study included in the study steering group consulted at all stages of the study via regular meetings co-producing the final recommendations contributing to how the results of the study will be sharedDisseminationWe will: present the findings at scientific conferences publish the findings in academic journals share the findings with dental policy makers setup a study Twitter site for posting regular updates write a summary blog with patient and public involvement for the Cleft Lip and Palate Association (CLAPA).

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: ORAL AND GASTROINTESTINAL