NCT07470437Recruiting
The Mouth Matters in Mental Health Trial -2
A Link Work Intervention to Support Dental Visiting in People With Severe Mental Health Difficulties: The Mouth Matters in Mental Health Effectiveness and Cost-Effectiveness Trial
Source: ClinicalTrials.gov · Last updated 27 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 480 (estimated)
- First submitted
- 10 Mar 2026
- Start date
- May 2026
- Primary completion date
- Jul 2029
- Lead sponsor
- Lancashire and South Cumbria NHS Foundation Trust
- Diseases
- Schizophrenia
- NCT number
- NCT07470437
What you commit to
- Study type: Interventional
- Planned participants: 480
- From May 2026 to the primary completion date, Jul 2029
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Current inpatient status on psychiatric ward. This does not include people in rehabilitation homes or supported accommodation in the community.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pennine Care NHS Foundation Trust Coordinator of this site? Confirm its status | Ashton-under-Lyne | United Kingdom | Recruiting |
| South London and Maudsley NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Not yet recruiting |
| Greater Manchester Mental Health NHS Foundation Trust Coordinator of this site? Confirm its status | Manchester | United Kingdom | Recruiting |
| Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Recruiting |
| Lancashire & South Cumbria NHS Foundation Trust Coordinator of this site? Confirm its status | Preston | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.