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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05695443
Other study ID # OralHlthRogaland
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2021
Est. completion date June 26, 2023

Study information

Verified date January 2024
Source Oral Health Center of Expertise Rogaland, Norway
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Motivational Interviewing
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.

Locations

Country Name City State
Norway Norwegian Correctional Service Sandnes

Sponsors (2)

Lead Sponsor Collaborator
Oral Health Center of Expertise Rogaland, Norway Helse Stavanger HF

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Other Questions asked by the prisoner Dental staff take notes of how many times the prisoner asks questions about his teeth. If the intervention successfully increases the prisoner's interest in his own oral health, we could expect more question about his oral health. Baseline-4 weeks-12 weeks
Primary 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 Questionnaire responses How would you rate your own dental health? Scores are measured on a five-point Likert-type scale from "very poor" to "very good"
Dental care products used (toothbrush, toothpaste, mouthwash, floss, toothpicks)
Drinking something added flavor/sugar during the last 4 weeks?
Eating sweet foods during the last 4 weeks?
Eaten/drinking sugary drinks outside of the main meals during the last 4 weeks?
Use of "Change plan"
Scores on 2-6 are measured on a six-point Likert-type scale from "several times a day" to "never")
How have you felt the last 4 weeks (very anxious, been so far down that nothing has been able to cheer you up, calm and harmonious, down and sad,happy?) Scores are measured on a six-point Likert-type scale (1=all the time, 2=almost all the time, 3=a lot of the time, 4=part of the time, 5=a little part of the time, 6=not at all)
Baseline- 4 weeks-12 weeks
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