People with severe mental health difficulties accessing secondary care mental health services who have not been to the dentist in the past 3 years Oral Health
Conditions
Interventions
The researchers will recruit 84 participants from three NHS Trusts in North West England. Randomisation will be via a secure 24-hour web-based randomisation programme managed centrally by Liverpool Cl
Sponsors
Lancaster University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged >18 years 2. Able to provide informed consent 3. Receipt of care from a Community Mental Health Team (or equivalent service) or Early Intervention Team at the point of referral 4. No routine and planned dental appointment in the past 3 years. The person should not have accessed a dental service (e.g. high street dentist, special care dentist service) for routine or planned dental care in the past 3 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. The researchers do not consider emergency dental care (e.g. attendance at A&E, dental hospital) within this definition, although any follow-up routine and planned appointments with a dentist would exclude the person from taking part.
Exclusion criteria
Exclusion criteria: 1. Inpatient status on a psychiatric or secure ward. The researchers will allow participants in supported living to take part as long as they are in receipt of care from a Community Mental Health Team (or equivalent service) or Early Intervention for Psychosis Service 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 the referrer in approximately 1 month’s time (or a time period agreed in collaboration with the individual) to determine if the risk has subsided to a point where they are now eligible. 3. Enrolled in a dental trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility outcomes measured at 9 months follow-up: 1. Recruitment rates: the ability to randomise 84 participants to target in a 7-month recruitment window. Green =80%. Amber 60-79%. Red =59%. 2. Visiting data: percentage of participants with available data on dental visiting via self-report or BSA. Green =90%. Amber 60-89%. Red =59%. 3. Clinical exam: percentage of participants completing the dental examination. Green =80%. Amber 60-79%. Red: =59%. 4. Adherence to intervention: percentage of participants receiving intervention =1 sessions during a 9-month window. Green =80%. Amber 60-79%. Red =59%. 5. Intervention and trial protocol: qualitative data to understand the acceptability and feasibility of the procedures, assessments, and intervention to inform a full trial and service delivery. 6. Safety of intervention: monitoring and review of research-related serious adverse events (SAEs). The trial steering committee (TSC) will oversee SAEs across treatment arms. The researchers will discontinue the trial if the intervention or procedures elevate risk. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proposed primary outcomes for definitive trial: 1. Planned dental appointment as measured by self-report at baseline and 9 months 2. Planned dental appointment as measured by business service authority data for the 9-month intervention window and recorded at follow-up Self-report assessments at baseline and 9 months: 1. Orofacial pain measured using the gold-standard Brief Pain Inventory – short form 2. Pain-related disability measured using the Manchester Orofacial Pain Disability Scale 3. Oral health related quality of life measured using the Oral Health Impact Profile 4. Self-efficacy around dental visiting measured using the items: ‘How confident are you that you will be able to attend a dental appointment?’ (1, no confident; 7, very confident) 5. Self-esteem using the Rosenberg Self-Esteem Scale (RSES) 6. Dental anxiety using the Modified Dental Anxiety Scale 7. Depression using the Patient Health Questionnaire 8. Quality-adjusted life year using the EuroQol 5 Dimension (EQ-5D-5L) 9. Access to free or subsidised dental care 10. The number of completed routine dental visits 11. Oral health self-management, namely the use of brushing, flossing, and mouthwash Dental examination at baseline and 9 months: 1. Decayed, missing or filled teeth scores by dental examination 2. Pulpal involvement, ulceration due to trauma, fistula, and abscess by dental examination 3. Modified Plaque Score by dental examination Business services authority (BSA) data on dental attendance, access to free dental care, treatment, and distance travelled to appointment. BSA variables will be assessed for the 9-month intervention window and recorded at follow-up. | — |
Countries
England, United Kingdom
Outcome results
None listed