The Mouth Matters in Mental Health Trial -2
Recruiting · NCT07470437 · Interventional (participants receive a specific treatment) · Lead sponsor: Lancashire and South Cumbria NHS Foundation Trust
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This clinical trial will evaluate the effectiveness and cost-effectiveness of a link work intervention for supporting people with severe mental health difficulties to attend a routine dental appointment. There are two main outcomes, namely: i) attendance at a routine dental appointment; and ii) oral health quality of life. The main predictions are that: 1. The link work intervention plus treatment as usual will lead to greater likelihood of attendance at a routine dental appointment, compared with treatment as usual alone. 2. The link work intervention plus treatment as usual will lead to better oral health quality of life, compared with treatment as usual alone. 3. The link work intervention plus treatment as usual will be cost-effective compared with treatment as usual alone.
Who can take part
Inclusion criteria
- Aged ≥18 years.
- Receipt of care from community mental health or early intervention teams at the point of referral.
- No routine dental appointment (e.g. high street dentist, special care dentist service) in the past three years. This would include any dental examination, diagnosis, advice or treatment (e.g. fillings, root canal, extractions, crowns, dentures, bridges) resulting from a routine (non-emergency) appointment at a dental service. Emergency dental care (e.g. emergency attendance at an Accident \& Emergency Appointment or a dental hospital) is not included within this definition, although any follow-up routine and planned appointments with a dentist would exclude the person from taking part.
- Able to provide informed consent as determined by trained researchers in consultation with the clinical team.
Exclusion criteria
- Current inpatient status on psychiatric ward. This does not include people in rehabilitation homes or supported accommodation in the community.
- Immediate risk to self or others operationalised as the presence of active intent or planning to harm oneself or others in the near future (e.g. next month), or a suicide attempt in the past month (e.g. life-threatening self-harm, overdose). Where individuals are excluded on this basis, with the person's consent, the researcher will aim to re-contact them and/or the referrer in approximately one-months' time to determine if risk has subsided to a point where they are now eligible.
- Enrolled in another dental randomised controlled trial.
Where it is running
5 locations listed.
- Pennine Care NHS Foundation Trust - Ashton-under-Lyne, United Kingdom
- South London and Maudsley NHS Foundation Trust - London, United Kingdom
- Greater Manchester Mental Health NHS Foundation Trust - Manchester, United Kingdom
- Lancashire & South Cumbria NHS Foundation Trust - Preston, Lancashire, United Kingdom
- Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust - Newcastle upon Tyne, Northumberland, United Kingdom