Title: Improving oral health in cleft lip and/or palate: A health promotion intervention for children and parents
Funder: Department of Health and Social Care

Abstract: Background: Oral health can affect all children s quality of life but has particular significance for those with a cleft lip and/or palate (CL/P), who have additional, unique needs relating to their teeth. Evidence suggests that oral health is worse among this population. Poor oral health can mean that treatment is less effective and procedures (e.g. bone graft, orthodontics) have to be repeated or are not offered as an option. Successful orthodontic treatment requires children to be active agents in maintaining oral health. In addition, poor oral health makes it more likely that children with CL/P, who already face several procedures throughout their life, including surgery, risk avoidable interventions (e.g. fillings and extractions), which add to healthcare as well as psychosocial costs (e.g. emotional upheaval, missing time from school). Aims: We will refine a brief intervention (implementation intentions or if-then plans) for children and parents to help patients with CL/P improve their oral health. We will then determine the feasibility of this approach by evaluating procedures, recruitment and retention, and finalising measures. The feasibility study will also explore whether providing a booster/reminder has the potential to sustain and/or enhance the effects of implementation intentions. Plan: Firstly, qualitative interviews will be conducted with approximately 20 children who have CL/P and their parents to explore their views of oral health, including barriers and enablers to following tooth-brushing and other oral health recommendations. Interview data will be used to refine the if-then plans (implementation intentions) for parents and children. A feasibility study is planned because there are a number of unknowns that need addressing before embarking on a full trial. For example, this research will help us decide on the format (content/mode of delivery) of the implementation intentions. It will examine the acceptability of proposed measures and processes involved in the trial from the perspective of participants. It will provide data that can be used to inform a power calculation in a follow-up, definitive trial. The feasibility study will have three arms (each involving 20 children and their parent(s)): In Group 1 (controls), parents will be given a short educational leaflet about oral health and children will be given a colouring/activity book on this topic. Group 2 will receive the same educational resources as controls. They will also be invited to make an implementation intention relating to oral health by a dental nurse. Similarly, in Group 3, the educational resources and implementation intentions will be provided to parents and children by a dental nurse but they will also receive a booster through the post 3 months later. This will consist of a reminder to use the implementation intentions as instructed in everyday life. Benefits to patients: Children with CL/P are required to maintain good oral health to ensure that future treatment (e.g. orthodontics, bone grafting) is successful. Implementation intentions, if effective, offer a brief approach for these families to improve a key aspect of health in CL/P, families who already have many other aspects of the child s well-being to manage (e.g. hearing, speech, appearance and quality of life). Benefits to NHS: Treatment for cleft (e.g. orthodontics, bone grafts) may be less successful if good oral health is not maintained. Therefore, targeting this aspect of patients self-care is important. If successful in this situation, use of implementation intentions could be extended to others who have to assume responsibility for self-care (e.g. children with asthma using preventative inhalers).

Lay abstract: Children with a cleft lip and/or palate (CL/P) often struggle to look after their teeth and have poor oral health. This can affect success of their treatment, including bone grafts and braces. We want to see whether an approach known as implementation intentions can help these children improve their oral health. Implementation intentions reflect the fact that people generally want to act in a healthy way but struggle to do so. They involve specifying a cue (e.g. getting ready for bed) and linking it with an appropriate response (e.g. brushing teeth). They have been shown to be effective for health behaviours such as diet and exercise. They have been used in a limited way with children in the past, but not with those who have CL/P. Firstly, we plan to interview primary school aged children with CL/P and their parent(s) about tooth-brushing, the transfer of responsibility for oral health, and factors assisting or preventing positive oral health behaviours. Information from the interviews will help us refine the intervention &ndash; the implementation intentions. We will then test the intervention in a feasibility study. The feasibility study will answer questions about how to carry out a large scale trial in the future. For example, it will help us decide on the content and method of delivery of implementation intentions to help improve the oral health of children with CL/P. The feasibility study will also examine the acceptability of proposed measures and processes involved in the trial from the perspective of participants. It will provide data we can use to decide on the sample size, how best to recruit and retain children and parents in a study. We plan to use this information to plan a full trial to test whether implementation intentions improve oral health in primary school children with CL/P.

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