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NCT Number: NCT07470437

The Mouth Matters in Mental Health Trial -2

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.

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Key information

Conditions

Mental Health Behavior Mental Disorders Oral Health Care Personal Satisfaction Psychological Well-Being Psychosis Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lancashire & South Cumbria NHS Foundation Trust, Preston, Lancashire, United Kingdom

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About this study

Aim: To evaluate the effectiveness and cost-effectiveness of a link work intervention to facilitate dental attendance in people with severe mental illness.

Methods: An effectiveness randomised-controlled trial with integrated cost-effectiveness analysis and process evaluation. 480 participants will be recruited from five NHS Trusts and randomised (ratio 1:1) to either treatment as usual or treatment as usual plus the link work intervention. The link work intervention will follow the manual co-developed and used in the feasibility trial. Blind research assistants will support participants to complete assessments at baseline and after nine-months. The investigators will obtain consent to access participant's dental visiting data via the Business Services Authority. The primary outcomes are i) attendance at a routine dental appointment, and ii) oral health related quality of life. Health economics analysis will assess whether the intervention is cost-effective. A qualitative process evaluation will help to understand how it works and might be implemented.

Results/conclusions: This research hopes to produce the first evidenced-based intervention for improving the oral health of people with severe mental illness. It could help to overcome inequities in dental access.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Link work intervention

Behavioral

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.

Primary outcomes

  1. Attendance at a planned care appointments

    Time frame: From baseline to nine-month follow-up assessment.

    As measured by the National Health Services Business Services Authority (NHS BSA).

  2. Oral health related quality of life

    Time frame: From baseline to nine-month follow-up assessment .

    Oral Health Impact Profile - 14 item version (OHIP-14), range: 0-56, higher scores indicate worse oral health related quality of life

Secondary outcomes

  1. Self-reported attendance at a planned dental appointment.

    Time frame: From baseline to nine-month follow-up assessment.

    Self-report dental attendance items.

  2. Orofacial pain & disability

    Time frame: From baseline to nine-month follow-up assessment

    Manchester Orofacial Pain Disability Scale. Two binary outcomes plus scale. Range: 0-52. Higher scores indicates greater pain (binary) / help seeking (binary) / pain related disability (scale).

  3. Confidence around dental visiting

    Time frame: From baseline to nine-month follow-up assessment.

    Single item of self-efficacy around attendance. Range 1-7. A higher score indicates greater confidence around dental visiting.

  4. Self-esteem

    Time frame: From baseline to nine-month follow-up assessment

    Rosenberg Self-Esteem Scale. Range: 0-30. A higher score indicates better self-esteem.

  5. Dental anxiety

    Time frame: From baseline to nine-month follow-up assessment.

    Modified Dental Anxiety Scale. Range: 5-25. A higher score indicates greater levels of dental anxiety.

  6. General anxiety

    Time frame: From baseline to nine-month follow-up assessment .

    Generalised Anxiety Disorder Questionnaire. Range: 0-21. A higher score indicates greater levels of anxiety.

  7. Depression

    Time frame: From baseline to nine-month follow-up assessment.

    Patient Health Questionnaire - 9 items. Range 0-27. A higher score indicates greater levels of depression.

  8. The number of planned dental appointments attended

    Time frame: From baseline to nine-month follow-up assessment.

    Recorded via the National Health Service Business Services Authority.

  9. Self-reported access to free/subsidised dental care.

    Time frame: From baseline to nine-month follow-up assessment.

    Self-report items

  10. Exemption status for dental care

    Time frame: From baseline to nine-month follow-up assessment.

    As recorded by the National Health Service Business Services Authority

  11. Completion of a course of dental treatment

    Time frame: From baseline to nine-month follow-up assessment.

    As record via the National Health Service Business Services Authority.

  12. Self-reported utilisation of urgent or emergency dental services.

    Time frame: From baseline to nine-month follow-up assessment.

    Self-report items

  13. Quality adjusted life years

    Time frame: From baseline to nine-month follow-up assessment.

    European Quality of Life five-dimensional questionnaire (EQ-5D-5L). Five health dimensions plus overall health score on a visual analogue scale range. Range on visual analogue scale: 0-100. A higher score indicates better health.

  14. Utilization of healthcare resources

    Time frame: From baseline to nine-month follow-up

    Co-designed health economics questionnaire recording utilisation of services and treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Palmier-Claus, PhD, DClinPsy

CONTACT

[email protected]

+44 1772 773500

Sponsors and collaborators

Lead sponsor

Lancashire and South Cumbria NHS Foundation Trust

Network

Collaborators

  • Greater Manchester Mental Health NHS Foundation Trust
  • King's College London
  • Lancaster University
  • Northumberland, Tyne and Wear NHS Foundation Trust
  • Pennine Care NHS Foundation Trust
  • South London and Maudsley NHS Foundation Trust
  • University of Leeds
  • University of Liverpool
  • University of Manchester

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 13, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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