Condition category
Mental and Behavioural Disorders
Date applied
11/05/2020
Date assigned
18/05/2020
Last edited
18/05/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Oral health is an important factor in the quality of life and overall health and well-being. People with mental health disorders are reported to have poorer oral health and poorer access to dental health services as compared to the general population. That is, there are barriers to oral health in adults with mental disorders. Little is known about why this patient group misses necessary dental treatment.
This study explores different aspects of oral health and dental health services use among persons with severe or long term mental illness.
We wanted to explore the experiences and views of patients with SMI regarding oral health care services and particularly to explore perceived barriers to obtaining optimal dental health care. Further, we wanted to identify possible facilitators to provide true access to dental health services for this population. The ultimate goal of our study was to develop and improve adequate oral health services for persons with SMI.

Who can participate?
Adults over 18 years who receive support from the Community Mental Health Services in a Norwegian municipality and live at home.

What does the study involve?
Participants were recruited by the Community mental health services. At the onset of the research project, all service users receiving individual support from the Community mental health team were informed and asked to participate by their individually assigned contact person in the team. Participation was based on informed and written consent. Participation in the study involved an intake interview by a clinical psychologist, and a dental examination by a dentist. When treatment needs were identified in the oral examination, dental treatment was offered and performed to all patients. As far as possible, dental treatment was arranged and carried out according to the patient’s own preferences.

What are the possible benefits and risks of participating?
Benefits: The participants were offered free oral examination and dental treatment from a highly competent dentist and were invited to bring about their own experiences of barriers and facilitators for dental care.
Risks: Telling your story about oral and mental health might be challenging for some and there could possibly be a risk for symptom increase. At the same time, a conversation like this can also be experienced as supportive. Interviewers and support persons has to take responsibility and be aware of this possible dilemma, and follow up participants when needed. The participants had ongoing contact with the Community mental health services during data collection.

Where is the study run from?
Stord Community Mental Health Centre (Norway)

When is the study starting and how long is it expected to run for?
October 2015 to December 2021

Who is funding the study?
1. Oral Health Centre of Expertise in Western Norway
2. Directorate of Health in Norway

Who is the main contact?
Jofrid Bjørkvik, jofrid.bjorkvik@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Jofrid Bjørkvik

ORCID ID

http://orcid.org/0000-0002-0270-3856

Contact details

Pb 2354
Møllendal
Bergen
5867
Norway
+47 41201631
jofrid.bjorkvik@vlfk.no

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

2015/1724-1

Study information

Scientific title

Oral health and dental treatment for persons with severe or long term mental illness

Acronym

Study hypothesis

The main goal of this study was to develop and improve adequate oral health services for persons with severe or long term mental illness (SMI). This study has three sub-objectives:
1. To study dental status and oral health for people affected by severe or long term mental health disorders
2. To explore perceived barriers to obtain optimal dental health care for patients with severe or long term mental illness, and to identify possible facilitators to provide true access to dental services for this population
3. To explore possibilities and obstacles to cooperation between dental health services and other health services that are relevant for this patient group

Ethics approval

Approved 22/10/2015, Regional Ethics Committee for Medical and Health Research in Western Norway (REK vest: Rogaland, Vestland, Norway; +47 55 97 50 00; rek-vest@uib.no), ref: 2015/1724-1

Study design

Longitudinal mixed-methods

Primary study design

Observational

Secondary study design

Longitudinal study

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

In need of long term psychosocial support

Intervention

Participants were recruited by the Community mental health services. At the onset of the research project, all service users receiving individual support from the Community mental health team were informed and asked to participate by their individually assigned contact person in the team (all psychiatric nurses). Participants have different psychiatric conditions, but are in need of long term psychosocial support.

Participation in the study involved an intake interview by the first author (JB, clinical psychologist PhD), a dental examination by the second author (DH, dentist), and a number of questionnaires comprising issues relevant for oral health. When treatment needs were identified in the oral examination, dental treatment was offered and performed to all patients. As far as possible, dental treatment was arranged and carried out according to the patient’s own preferences. There was a follow-up interview after completion of dental treatment in order to validate the content of the first interview and to provide the participants with an opportunity to add new information.

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

At baseline and follow up (after treatment end):
1. Dental anxiety measured using Modified Dental Anxiety Scale (MDA) and Index of Dental Anxiety and Fear (IDAF)
2. Oral quality of life measured using Oral Impact on Daily Performance (OIDP) questionnaire
3. Dry Mouth measured using the Xerostomy inventory
4. Dental hygiene measured using scale with four categories of never or rarely twice a day to questions about how often they brush their teeth, use dental floss or toothpicks, use mouthwash or fluoride
5. Smoking status (yes/no)
6. Mental health disorder measured using the Mini International Neuropsychiatric Interview) (M.I.N.I) Norwegian Translation Version 6.0.0
7. Oral status measured using dental survey conducted by dentist (DMFT index, Oral hygiene index, Periodontal Index, Sialometri)

Secondary outcome measures

Barriers and facilitators for oral health and access to dental services for people with SMI measured using semi-structured interview at baseline and follow up (after treatment end)

Overall trial start date

01/10/2015

Overall trial end date

31/12/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Receive support from the Community Mental Health Services in a Norwegian municipality
2. 18 years old or more
3. Psychiatric health challenges and are in need of psychosocial support
4. Live in their own homes

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

All service-users receiving support from the Community Me All service users (N=82) receiving individual support from the Community mental health team were informed and asked to participate. This was done in order to secure rich and diverse data from participants in the target group on the research question.

Total final enrolment

52

Participant exclusion criteria

Not understanding Norwegian or English language

Recruitment start date

01/12/2017

Recruitment end date

01/03/2019

Locations

Countries of recruitment

Norway

Trial participating centre

Community dental clinic
Stord
Stord
5401
Norway

Trial participating centre

Community Mental Health Centre
Stord
Stord
5401
Norway

Trial participating centre

Oral Health Centre of Expertise in Western Norway
Pb 2354 Møllendal
Bergen
5867
Norway

Sponsor information

Organisation

Oral Health Centre of Expertise in Western Norway

Sponsor details

Pb 2354
Møllendal
Bergen
5867
Norway
+47 55337600
ellen.berggren@vlfk.no

Sponsor type

Hospital/treatment centre

Website

https://www.vestlandfylke.no/tannhelse/tkvestland/

Funders

Funder type

Hospital/treatment centre

Funder name

Oral Health Centre of Expertise in Western Norway

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Directorate of Health in Norway

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Barriers and facilitators for dental treatment for people with severe mental illness (qualitative study, intended to be published in 2020 or 2021.
Oral health and dental treatment in persons with severe mental illness in Norway, as compared to general public norms.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date

Intention to publish date

31/12/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

18/05/2020: Trial’s existence confirmed by Regional Ethics Committee for Medical and Health Research in Western Norway.