Drug-free Without Toothache. A Study of Free Dental Treat... | NCT05606562

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

NCT05606562

Sponsor

University Hospital of North Norway

Status

Recruiting

Last Update Posted

Nov 4, 2022Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Substance Abuse
Dental Caries

Interventions

Dental care

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 6, 2022Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Feb 24, 2022

First Submission Date that Met QC Criteria

Oct 31, 2022

First Posted Date

Nov 4, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 31, 2022

Last Update Posted Date

Nov 4, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dental treatment	Experimental	All participants will be offered dental treatment for free.	Procedure: Dental care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dental care	Procedure	Participants will be offered free dental care	Dental treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dental treatment	Proportion of participant who attend and complete dental treatment during the hospital stay.	Approximately 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
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.	Approximately 12 weeks
Aspects of dental treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

People who are hospitalized for drug abuse at Russeksjon UNN Narvik.

Exclusion Criteria:

Non

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Stian Anthonsen, MD	Contact	97710986		andreas.holund@unn.no
Stian Anthonsen	Contact	+4797710986		stian.anthonsen@unn.no

Overall Officials

Name	Affiliation	Role
Merethe Kumle, MD, PhD	University Hospital of North Norway	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital North Norway	Recruiting	Narvik	Nordland	8521	Norway

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 1, 2020	Apr 6, 2022	Prot_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D019966	Substance-Related Disorders
D003731	Dental Caries

Ancestor Terms

ID	Term
D064419	Chemically-Induced Disorders
D001523	Mental Disorders
D017001	Tooth Demineralization
D014076	Tooth Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003729	Dental Care

Ancestor Terms

ID	Term
D003813	Dentistry
D003752	Dental Health Services
D006296	Health Services
D005159	Health Care Facilities Workforce and Services

Browse Leaves

Not provided

Browse Branches

Not provided