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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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN94481360
Enrollment
480
Registered
2026-03-13
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Access to planned dental care in people experiencing severe mental health difficulties. Oral Health

Interventions

Treatment as usual arm: Treatment as usual will include any treatments or services that the participant would normally have access to outside of the trial. For people with severe mental illness this m

Sponsors

Lancashire and South Cumbria NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 120 Years

Inclusion criteria

Inclusion criteria: 1. Aged =18 years. 2. Receipt of care from community mental health or early intervention teams at the point of referral. 3. 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. We do not consider emergency dental care (e.g. emergency attendance at Accident & Emergency Department or a dental hospital) within this definition, although any follow-up routine and planned appointments with a dentist would exclude the person from taking part. 4. Able to provide informed consent as determined by trained researchers in consultation with the clinical team.

Exclusion criteria

Exclusion criteria: Current key exclusion criteria as of 27/07/2026: 1. Current inpatient status on psychiatric ward. This does not include people in rehabilitation homes or supported accommodation in the community. 2. 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. 3. Enrolled in another dental randomised controlled trial. Previous key exclusion criteria: 1. Current inpatient status on psychiatric ward. This does not include people in rehabilitation homes or supported accommodation in the community. 2. 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. 3. Enrolled in another dental randomised controlled trial.

Design outcomes

Primary

MeasureTime frame
Attendance at a planned dental appointment measured using data from the NHS Business Services Authority (BSA) at 9-months;Oral health related quality of life measured using Oral Health Impact Profile - 14 item version (OHIP-14) at 9-months

Secondary

MeasureTime frame
Self-reported attendance at a planned dental appointment (private or NHS) measured using self-report items at 9-months;Orofacial pain & disability measured using Manchester Orofacial Pain Disability Scale at 9-months;Confidence around dental visiting measured using a self-report item at 9-months;Self-esteem measured using the Rosenberg Self-Esteem Scale at 9-months;Dental anxiety measured using the Modified Dental Anxiety Scale at 9-months;Depression measured using the Patient Health Questionnaire at 9-months;General anxiety measured using the Generalised Anxiety Disorder Questionnaire (GAD-7) at 9-months;The number of planned dental appointments attended measured using NHS Business Services Authority (BSA) data assessed at 9-months;Self-reported access to free/subsidised dental care measured using self-report items at 9-months;Exemption status for dental care measured using the NHS Business Services Authority (BSA) at 9-months;Completion of a course of dental treatment measured using the NHS Business Services Authority (BSA) at 9-months;Self-reported utilisation of urgent or emergency dental services measured using self-report items at 9-months;Quality adjusted life years measured using the European Quality of Life Five-Dimensional Questionnaire (EQ-5D-5L) at 9-months;Utilisation of healthcare resources measured using a co-designed health economics questionnaire at 9-months

Countries

England, United Kingdom

Contacts

Public ContactJasper Palmier-Claus
J.Palmier-Claus@lancaster.ac.uk+44 (0)1524 65201

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 25, 2026