NCT05695443

Brief Summary

This study investigates the effects of an intervention based on Motivational Interviewing (MI) on oral hygiene, oral cleaning routines, and attitudes toward own oral health of prisoners in Norway. Motivational Interviewing is a collaborative, person-centered form of guiding to elicit and strengthen motivation for change. All prisoners in the study undergo an oral examination to establish a baseline of oral health and a comprehensive questionnaire to identify risk factors and their attitudes towards their oral health and oral treatment. Norwegian-speaking prisoners are then randomized into either a treatment or control group. In the treatment group, dental staff initiate a conversation with the prisoner based on techniques from MI. Both groups finally receive a toilet bag with basic equipment to regularly clean their teeth. After 4 weeks and 12 weeks, prisoners are invited back for another oral examination and a follow-up questionnaire, to measure changes in oral hygiene, oral cleaning routines, and attitude toward their oral health. At four weeks a screening of general learning difficulties using the validated screening tool The Hayes Ability Screening Index (HASI) will be conducted. If the intervention proves to be an effective tool in improving oral hygiene, oral cleaning routines, and/or attitude towards own oral health, it can serve as an alternative proactive approach to improve the oral health of a vulnerable group in society. If the improvements in oral hygiene and oral cleaning routines are long-lasting, this may in turn lead to a reduced need for oral treatment. An improved attitude towards own oral health may, together with other rehabilitation programs in prison, improve the prisoner's self-esteem and chances to successfully returning to society after having served their prison sentence.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
328

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 22, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 25, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2023

Completed
Last Updated

January 23, 2024

Status Verified

January 1, 2024

Enrollment Period

1.6 years

First QC Date

November 22, 2022

Last Update Submit

January 20, 2024

Conditions

Keywords

Oral healthPrisonerMotivational InterviewingOral hygiene

Outcome Measures

Primary Outcomes (1)

  • Changes from baseline Mucosal-plaque index (MPS)

    A four-point plaque score (PS) and a four-point mucosal score (MS). For the PS, score of 1 suggests no visible plaque, score of 2 suggests plaque is barely visible, score of 3 suggests a moderate amount of plaque, and score of 4 suggests large amount of plaque almost covering the whole surface of teeth. For the MS, score of 1 suggests normal mucosal, score of 2 suggests mild inflammation, score of 3 suggests medium inflammation, and score of 4 suggests strong inflammation. For both scores, if in doubt between 1 and 2, they are instructed to score 1. If in doubt between 3 and 4, they are instructed to score 4. The index is designed to evaluate oral health and oral hygiene in groups of individuals. This makes it a suitable index to be used when conditions are not optimal to assess the patient. In prison, dental staff have limited equipment and poor light compared to an ordinary dental clinic. Therefore, using an index designed to be used outside of clinics was important.

    Baseline- 4 weeks-12 weeks

Secondary Outcomes (1)

  • Questionnaire responses

    Baseline- 4 weeks-12 weeks

Other Outcomes (1)

  • Questions asked by the prisoner

    Baseline-4 weeks-12 weeks

Study Arms (2)

Motivational Interviewing

EXPERIMENTAL

Prisoners in this group are subjected to a MI-based conversation lasting up to 30 minutes aiming at improving oral health and oral health related behavior

Behavioral: Motivational Interviewing

Control group

NO INTERVENTION

Prisoners in this group do not receive the MI-based intervention

Interventions

This study investigates the effects of an intervention based on Motivational Interviewing (MI) on oral hygiene, oral cleaning routines, and attitudes towards own oral health. The first step is for the dental staff to ask open questions to the prisoner about their oral health or oral health behavior. The next step is to confirm to the prisoner what he or she is doing. The third step is called reflection. At this stage, dental staff tries to provide reflections on what the prisoner have said, for example by repeating what the prisoner have said or say the same using synonyms (simple reflection), by extracting the underlying opinion or feeling (complex reflection), or by illuminate both negative and positive sides of the situation (double sided reflection). The final step is to summarize the conversation. In addition, the intervention includes a change plan, in which the prisoner and dental staff agrees on specific behavior that the prisoner should follow based on the MI conversation.

Motivational Interviewing

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Everyone serving time in one of the four prisons during the period of the study (November 2021 to June 2023)
  • Sufficient Norwegian language

You may not qualify if:

  • \- Insufficient Norwegian language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian Correctional Service

Sandnes, 4302, Norway

Location

Related Publications (1)

  • Bryne E, Bergum KH, Gjedrem WG. Improving Oral Health in Prisons (PriOH): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Dec 11;13:e60817. doi: 10.2196/60817.

MeSH Terms

Interventions

Motivational Interviewing

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Vibeke H Bull, PhD

    Oral Health Centre of Expertise, Stavanger

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Prisoners are not informed whether they are in the treatment or control group and are therefore blind to treatment status. Dental staff is blind to prisoners' treatment status at the first oral examination and questionnaire. The prisoner's treatment status is revealed just after this. Hence, dental staff collects data prior to knowing the prisoners' treatment status, and only learns this when they start the MI-based conversation. When prisoners are back at T1 and T2 for follow-up oral examinations and questionnaires, dental staff might still remember whether the prisoner was treated or not. To partially account for potential bias in the oral examination (assessment of plaque and mucosal inflammation), there are two independent assessments of this at T1 and T2.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Following the initial oral examination and questionnaire, prisoners are randomly assigned into either a treatment or control group, blocking at prison level. The randomization tool at www.randomizer.org is used. Prisoners in the treatment group receive an up to 30 Motivational Interviewing conversation, aiming at improving oral health and oral health-related behavior. The intervention is carried out by dental staff in prison. Prisoners in the control group do not receive the MI intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2022

First Posted

January 25, 2023

Study Start

November 1, 2021

Primary Completion

June 26, 2023

Study Completion

June 26, 2023

Last Updated

January 23, 2024

Record last verified: 2024-01

Locations