Substance AbuseRUSTNCT05606562
Drug-free Without Toothache. A Study of Free Dental Treatment as a Part of Substance Abuse Treatment
A study testing Dental care in people with Substance Abuse and Dental Caries, run by University Hospital of North Norway at 1 site in Norway.
Trial summary
Objectives: The main objective of the study is to investigate 1. 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". 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Abuse, Dental Caries
- What is being tested?
- Dental care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNorway
- Study dates
- 6 Apr 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People who are hospitalized for drug abuse at Russeksjon UNN Narvik.
Who cannot join
- Non
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
University Hospital North Norway
Narvik, Nordland, 8521
About this study
Official title: 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?
Read the 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.
- Conditions
- Substance Abuse, Dental Caries
- Being tested
- Dental care
- Keywords
- Non Randomized Interventional study
- Medical subject headings
- Substance-Related Disorders, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental careProcedure or surgery
Participants will be offered free dental care
| Study group | Role | What they receive |
|---|---|---|
| Dental treatment | Experimental | All participants will be offered dental treatment for free. Receives: Procedure: Dental care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental treatment
Proportion of participant who attend and complete dental treatment during the hospital stay.
Measured: Approximately 12 weeks
Secondary outcomes (2)
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.
Measured: Approximately 12 weeks
Aspects of dental treatment
Will dental treatment have positive or negative impact on drug abuse treatment
Measured: Approximately 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start6 Apr 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Merethe Kumle, MD, PhD, Principal investigator, University Hospital of North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05606562
- Sponsor's protocol ID
- #34765
- Acronym
- RUST
- Status last verified
- Feb 2022
- First submitted
- 24 Feb 2022
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug-free Without Toothache. A Non-randomized Intervention Study of Free Dental Treatment as a Part of Substance Abuse Treatment.
- ClinicalTrials.gov ID
- NCT05606562
- Acronym / sponsor ID
- RUST / #34765
- Conditions
- Substance Abuse, Dental Caries
- Keywords
- Non Randomized Interventional study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Study start
- 6 Apr 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dental treatment | Experimental | Procedure: Dental careAll participants will be offered dental treatment for free. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- People who are hospitalized for drug abuse at Russeksjon UNN Narvik.
Key exclusion criteria (1 listed)
- Non
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental careParticipants will be offered free dental care | Procedure or surgery | Dental treatment |
Primary outcome
Dental treatment
Time frame: Approximately 12 weeks
Proportion of participant who attend and complete dental treatment during the hospital stay.
2 secondary outcomes
Probability measures
Time frame: Approximately 12 weeks
Aspects of dental treatment
Time frame: Approximately 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Merethe Kumle, MD, PhD principal investigator
University Hospital of North Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental care in people with Substance Abuse and Dental Caries, run by University Hospital of North Norway at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stian Anthonsen, MD (97710986, andreas.holund@unn.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental treatment (time frame: Approximately 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.