- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05606562
Drug-free Without Toothache. A Study of Free Dental Treatment as a Part of Substance Abuse Treatment (RUST)
October 31, 2022 updated by: University Hospital of North Norway
Drug-free Without Toothache. A Non-randomized Intervention Study of Free Dental Treatment as a Part of Substance Abuse Treatment.
Objectives: The main objective of the study is to investigate
- How many patients will attend and complete dental care if they are offered it for free during the stay at "The department of substance abuse treatment, University Hospital North Norway (UNN) in Narvik".
- Explore whether a parallel dental treatment in addition to the other treatment at the department has a beneficial effect on the abuse treatment, or whether it can be disruptive to offer dental treatment in combination with admission for drug rehabilitation?
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This is a non-randomized clinical study without a control group.
Approximately 50 persons admitted to "The department of substance abuse treatment (Russeksjon UNN Narvik)" will be offered free dental service during treatment for drug addiction.
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Stian Anthonsen, MD
- Phone Number: 97710986
- Email: andreas.holund@unn.no
Study Contact Backup
- Name: Stian Anthonsen
- Phone Number: +4797710986
- Email: stian.anthonsen@unn.no
Study Locations
-
-
Nordland
-
Narvik, Nordland, Norway, 8521
- Recruiting
- University Hospital North Norway
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
People who are hospitalized for drug abuse at Russeksjon UNN Narvik.
Exclusion Criteria:
Non
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dental treatment
All participants will be offered dental treatment for free.
|
Participants will be offered free dental care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dental treatment
Time Frame: Approximately 12 weeks
|
Proportion of participant who attend and complete dental treatment during the hospital stay.
|
Approximately 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Probability measures
Time Frame: Approximately 12 weeks
|
Measurement of drop-out from dental treatment.
Which factors increase the success of dental treatment (we do not know which factors this will be.
This is an exploratory analysis.
|
Approximately 12 weeks
|
Aspects of dental treatment
Time Frame: Approximately 12 weeks
|
Will dental treatment have positive or negative impact on drug abuse treatment
|
Approximately 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Merethe Kumle, MD, PhD, University Hospital of North Norway
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 6, 2022
Primary Completion (Anticipated)
December 31, 2025
Study Completion (Anticipated)
December 31, 2026
Study Registration Dates
First Submitted
February 24, 2022
First Submitted That Met QC Criteria
October 31, 2022
First Posted (Actual)
November 4, 2022
Study Record Updates
Last Update Posted (Actual)
November 4, 2022
Last Update Submitted That Met QC Criteria
October 31, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- #34765
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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