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
2 other identifiers
interventional
480
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2026
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2026
CompletedFirst Posted
Study publicly available on registry
March 13, 2026
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2029
March 17, 2026
March 1, 2026
3.3 years
March 10, 2026
March 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Attendance at a planned care appointments
As measured by the National Health Services Business Services Authority (NHS BSA).
From baseline to nine-month follow-up assessment.
Oral health related quality of life
Oral Health Impact Profile - 14 item version (OHIP-14), range: 0-56, higher scores indicate worse oral health related quality of life
From baseline to nine-month follow-up assessment .
Secondary Outcomes (14)
Self-reported attendance at a planned dental appointment.
From baseline to nine-month follow-up assessment.
Orofacial pain & disability
From baseline to nine-month follow-up assessment
Confidence around dental visiting
From baseline to nine-month follow-up assessment.
Self-esteem
From baseline to nine-month follow-up assessment
Dental anxiety
From baseline to nine-month follow-up assessment.
- +9 more secondary outcomes
Study Arms (2)
Treatment as usual
NO INTERVENTIONTreatment 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 may include support from a care coordinator, support worker, psychologist, occupational therapist, and/or psychiatrist for care around their mental health. Treatment as usual may include medication and case management. The investigators will monitor, rather than withhold, assessment and treatment for oral health in the treatment as usual arm.
Treatment as usual plus a link work intervention
EXPERIMENTALParticipants in this arm will receive treatment as usual plus the link work intervention. This will consist of six sessions with a link worker over nine-months who will offer practical and emotional support around accessing a routine dental appointment.
Interventions
The mental health link work intervention uses link workers to empower and assist people with severe mental illness currently supported by secondary care mental health services, but not dental services, to access planned dental appointments. The link work intervention in the study proposal has the following dimensions: * Delivered by mental health support workers. * Focused on oral health as the primary health issue. * Setting is in secondary mental health care linking to dental care * Primary role is navigating or bridging services. * It builds motivation where needed and offers advocacy. * Its builds self-efficacy and recursively through social persuasion, positive reinforcement, and positive experiences of dental visits and interacting with dental services. * Training and supervision to link workers supports intervention delivery.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lancashire and South Cumbria NHS Foundation Trustlead
- Greater Manchester Mental Health NHS Foundation Trustcollaborator
- Pennine Care NHS Foundation Trustcollaborator
- Northumberland, Tyne and Wear NHS Foundation Trustcollaborator
- South London and Maudsley NHS Foundation Trustcollaborator
- Lancaster Universitycollaborator
- University of Liverpoolcollaborator
- University of Leedscollaborator
- University of Manchestercollaborator
- King's College Londoncollaborator
Study Sites (5)
Lancashire & South Cumbria NHS Foundation Trust
Preston, Lancashire, PR2 8DW, United Kingdom
Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
Newcastle upon Tyne, Northumberland, NE3 3XT, United Kingdom
Pennine Care NHS Foundation Trust
Ashton-under-Lyne, OL67SR, United Kingdom
South London and Maudsley NHS Foundation Trust
London, SE5 8AF, United Kingdom
Greater Manchester Mental Health NHS Foundation Trust
Manchester, M253BL, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Research assistants undertaking clinical assessments will be blind to the treatment allocation. The investigators will monitor and record all breaking of the blind on a structured form. The co-investigator team, TSC and DMC will review blind breaks to establish and implement learning and reduce further blind breaks. Where possible, when one researcher becomes unblinded, a second unblinded researcher will complete the assessment. Deliberate unblinding of the researchers during the trial is unlikely, but will be considered by the senior management team and could occur in cases of risk or safeguarding. Statisticians will be masked to randomisation outcome until finalisation of the statistical analysis plan to avoid bias.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Investigator; Senior Lecturer; Principal Clinical Psychologist
Study Record Dates
First Submitted
March 10, 2026
First Posted
March 13, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
July 31, 2029
Study Completion (Estimated)
July 31, 2029
Last Updated
March 17, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Exact plans and timescales will be developed during the early phases of the project and outlined within a Data Access Management Plan (DAMP). The IPD will only be available from the point of the results being published and after 31/07/2029.
- Access Criteria
- Exact specifications around who can apply for access to anonymized data and how will be outlined in the Data Access Management Plan (DAMP). Key considerations will include the confidentiality and privacy of participants; respect to the terms of consent by individuals who are involved in research; consistency with relevant legal, ethical and regulatory frameworks; and guarding against unreasonable costs.
Following publication of the trial results, the investigators will make suitable arrangements for anonymised data to be available from the research team, in line with NIHR data sharing guidance. This will be outlined in the Data Access Management Plan (DAMP) developed in the early phases of the project.