The Mouth Matters in Mental Health Trial -2
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLancashire and South Cumbria NHS Foundation Trust
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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). 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.
Trial design
Treatments tested in this trial
- Link work intervention
Treatment groups
480 Participants
are divided into 2 treatment groupsSponsors and collaborators
Lancashire and South Cumbria NHS Foundation Trust
Lead sponsor
Lancaster University
Sponsor institution
Greater Manchester Mental Health NHS Foundation Trust
Collaborator
Pennine Care NHS Foundation Trust
Collaborator
Northumberland, Tyne and Wear NHS Foundation Trust
Collaborator
South London and Maudsley NHS Foundation Trust
Collaborator
Lancaster University
Collaborator
University of Liverpool
Collaborator
University of Leeds
Collaborator
University of Manchester
Collaborator
King's College London
Collaborator
Source ClinicalTrials.gov