search
Back to results

Drug-free Without Toothache. A Study of Free Dental Treatment as a Part of Substance Abuse Treatment (RUST)

Primary Purpose

Substance Abuse, Dental Caries

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Dental care
Sponsored by
University Hospital of North Norway
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Substance Abuse focused on measuring Non Randomized Interventional study

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: People who are hospitalized for drug abuse at Russeksjon UNN Narvik. Exclusion Criteria: Non

Sites / Locations

  • University Hospital North NorwayRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dental treatment

Arm Description

All participants will be offered dental treatment for free.

Outcomes

Primary Outcome Measures

Dental treatment
Proportion of participant who attend and complete dental treatment during the hospital stay.

Secondary Outcome Measures

Probability measures
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.
Aspects of dental treatment
Will dental treatment have positive or negative impact on drug abuse treatment

Full Information

First Posted
February 24, 2022
Last Updated
October 31, 2022
Sponsor
University Hospital of North Norway
search

1. Study Identification

Unique Protocol Identification Number
NCT05606562
Brief Title
Drug-free Without Toothache. A Study of Free Dental Treatment as a Part of Substance Abuse Treatment
Acronym
RUST
Official Title
Drug-free Without Toothache. A Non-randomized Intervention Study of Free Dental Treatment as a Part of Substance Abuse Treatment.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 6, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital of North Norway

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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?
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse, Dental Caries
Keywords
Non Randomized Interventional study

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dental treatment
Arm Type
Experimental
Arm Description
All participants will be offered dental treatment for free.
Intervention Type
Procedure
Intervention Name(s)
Dental care
Intervention Description
Participants will be offered free dental care
Primary Outcome Measure Information:
Title
Dental treatment
Description
Proportion of participant who attend and complete dental treatment during the hospital stay.
Time Frame
Approximately 12 weeks
Secondary Outcome Measure Information:
Title
Probability measures
Description
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.
Time Frame
Approximately 12 weeks
Title
Aspects of dental treatment
Description
Will dental treatment have positive or negative impact on drug abuse treatment
Time Frame
Approximately 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: People who are hospitalized for drug abuse at Russeksjon UNN Narvik. Exclusion Criteria: Non
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stian Anthonsen, MD
Phone
97710986
Email
andreas.holund@unn.no
First Name & Middle Initial & Last Name or Official Title & Degree
Stian Anthonsen
Phone
+4797710986
Email
stian.anthonsen@unn.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merethe Kumle, MD, PhD
Organizational Affiliation
University Hospital of North Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital North Norway
City
Narvik
State/Province
Nordland
ZIP/Postal Code
8521
Country
Norway
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Drug-free Without Toothache. A Study of Free Dental Treatment as a Part of Substance Abuse Treatment

We'll reach out to this number within 24 hrs