Protocol for a feasibility trial of a co-produced intervention: ‘Enabling Service Users with Severe Mental Illness to Learn about and Engage with Good Oral Health (SMILE)’
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Background
People with severe mental illness (SMI) report poorer oral health outcomes than the general population, are less likely to attend regular dental check-ups, and may require additional support to visit a dentist. Our previous research showed that interventions tailored to their needs and support from the mental health care system are needed to improve oral health outcomes in people with SMI. Although there is some provision of urgent dental care for people with SMI, there are currently limited available interventions that integrate dental and mental health care and provide dental support in a mental healthcare setting. To address this gap, the aims of the SMILE project are to 1) co-develop and 2) test the feasibility and acceptability of an oral health intervention for people with SMI, delivered by mental health professionals in secondary community mental health care settings. This paper describes the protocol for the feasibility and acceptability testing of the SMILE intervention.
Methods
This is a single-arm, non-randomised feasibility trial assessing the feasibility and acceptability of an intervention to support the oral health of mental healthcare service users with SMI. The intervention was co-produced with service users, carers, mental health and dental health professionals, and includes advice on maintaining good oral hygiene and lifestyle habits to maintain good oral health. The main aim of the study is to assess the feasibility and acceptability of delivering the intervention, using quantitative data collected at baseline, three and six-month follow-up, and qualitative interviews with participants and mental health staff involved in delivering the intervention.
Results
The study results will determine whether the intervention can be successfully delivered in secondary community mental health care settings and inform the most appropriate primary and secondary outcomes for a future trial.
Conclusion
The findings of this study will inform the feasibility of progression to the pilot stage of a randomised controlled trial to assess the clinical and cost effectiveness of delivering an oral health intervention in a mental healthcare setting.
Trial registration
This protocol was pre-registered via the ISRCTN (ref no.: ISRCTN44497673 ) on 19/02/2026.
