Oral and Dental Health in Substance Dependent Individuals (ODH_SUD)

October 11, 2024 updated by: Hasan Tahsin Kilic, Izmir Democracy University

The Evaluation of Oral and Dental Health in Substance Dependent Individuals

The goal of this cross-sectional clinical study is to compare the oral health status of individuals with Methamphetamine (MA), Cannabis (THC), and Polysubstance (PSU) use disorders to healthy controls. The study aims to answer:

How does substance use type (Methamphetamine, Cannabis, Polysubstance) affect dental health outcomes as measured by the DMFT index? What is the relationship between substance use characteristics (type, duration, and quantity) and oral health behaviors? Researchers will compare individuals with substance use disorders to a control group of healthy, non-substance-using individuals to assess the impact of different substances on dental health.

Participants will:

Undergo a clinical oral examination to evaluate dental health using the DMFT index.

Complete a questionnaire on sociodemographic information, substance use history, and oral health behaviors based on the Hiroshima University Dental Behavior Inventory (HU-DBI).

This study contributes to understanding the dental health needs of individuals with substance use disorders and the importance of tailored dental interventions for this population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This cross-sectional clinical study was conducted at İzmir Democracy University Buca Seyfi Demirsoy Education and Research Hospital Probation Clinic from April to August 2024. In line with Turkish policy, individuals involved in substance-related offenses attended probation clinics, where this study's participants were recruited. A sample of 190 individuals with Methamphetamine (MA), Cannabis (THC), and Polysubstance (PSU) use disorders was compared to a control group of 91 healthy male hospital employees with no history of substance use.

All participants underwent clinical oral health examinations performed by a trained dental student and specialist dentist, assessing dental health using the Decayed, Missing, and Filled Teeth (DMFT) index based on WHO diagnostic criteria. The clinical assessments were conducted with a portable dental chair, artificial lighting, and a dental mirror. The examiners were blinded to participants' substance use and sociodemographic details.

In addition to clinical examinations, sociodemographic data, substance use history, and oral health behaviors were collected through a researcher-developed questionnaire and the Turkish version of the Hiroshima University Dental Behavior Inventory (HU-DBI). The study aimed to identify differences in dental health outcomes across substance use groups and to assess the relationships between oral health and variables such as substance type, usage duration, and oral health behaviors.

Statistical analyses were conducted using SPSS 26.0, applying t-tests, ANOVA, Chi-square tests, and Pearson correlation to evaluate differences and correlations across variables. A significance level of p<0.05 was applied for all tests. The findings contribute to understanding the dental health needs of individuals with substance use disorders, underscoring the importance of targeted dental care interventions for this population.

Study Type

Interventional

Enrollment (Actual)

281

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 Locations

  • Turkey
    • Konak
      • İzmir, Konak, Turkey
        • İzmir Demokrasi Üniversitesi

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Male participants
  • aged 18 to 45
  • methamphetamine, cannabis, or polysubstance users.

Exclusion Criteria:

  • absence of urine toxicology analysis results,
  • use of substances other than methamphetamine or cannabis,
  • being under the influence of substances during the evaluation
  • not meeting DSM-5 criteria for Substance Use Disorder,
  • having any systemic medical conditions
  • current medication use
  • incomplete scales and forms.
  • who wore removable dentures
  • In the control group, individuals with a history of any substance use

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: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: Methamphetamine Use Group
This group consists of individuals diagnosed with Methamphetamine Use Disorder. Diagnoses were conducted by the same psychiatrist for all participants. Following psychiatric evaluation, participants underwent a clinical oral health examination to assess their dental health status, with the Decayed, Missing, and Filled Teeth (DMFT) index being calculated afterward. This group is included to investigate the impact of methamphetamine use on oral health.
Diagnostic test: Dental caries was assessed using the DMFT index (Decayed, Missing, and Filled Teeth) according to the World Health Organization's caries diagnostic criteria.
The same psychiatrist administered the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) to all participants. Oral health examinations were performed by a trained dental student and a specialist dentist using a portable dental chair, artificial light, and a dental mirror. Dental caries was assessed using the DMFT index (Decayed, Missing, and Filled Teeth) according to the World Health Organization's caries diagnostic criteria. This index included the number of decayed, missing (due to caries, excluding 3rd molars), and filled teeth in the permanent dentition. The oral health examiners were blinded to each participant's substance use type and sociodemographic information.
Diagnostic test: Substance Use Disorder Diagnosis
This intervention involves a psychiatric evaluation conducted by a licensed psychiatrist to diagnose Substance Use Disorder according to the criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). The psychiatrist performs a comprehensive assessment of each participant's substance use history and related behaviors. This diagnosis step is essential for identifying participants with specific substance use disorders, such as Methamphetamine, Cannabis, or Polysubstance Use Disorders, before proceeding with the dental health examination.
Experimental: Arm 2: Cannabis Use Group
This group consists of individuals diagnosed with Cannabis Use Disorder. Diagnoses were performed by the same psychiatrist for consistency. After the psychiatric assessment, participants received a clinical oral health examination to determine their dental health status, and the DMFT index was calculated subsequently. This group aims to assess the effects of cannabis use on oral health.
Diagnostic test: Dental caries was assessed using the DMFT index (Decayed, Missing, and Filled Teeth) according to the World Health Organization's caries diagnostic criteria.
The same psychiatrist administered the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) to all participants. Oral health examinations were performed by a trained dental student and a specialist dentist using a portable dental chair, artificial light, and a dental mirror. Dental caries was assessed using the DMFT index (Decayed, Missing, and Filled Teeth) according to the World Health Organization's caries diagnostic criteria. This index included the number of decayed, missing (due to caries, excluding 3rd molars), and filled teeth in the permanent dentition. The oral health examiners were blinded to each participant's substance use type and sociodemographic information.
Diagnostic test: Substance Use Disorder Diagnosis
This intervention involves a psychiatric evaluation conducted by a licensed psychiatrist to diagnose Substance Use Disorder according to the criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). The psychiatrist performs a comprehensive assessment of each participant's substance use history and related behaviors. This diagnosis step is essential for identifying participants with specific substance use disorders, such as Methamphetamine, Cannabis, or Polysubstance Use Disorders, before proceeding with the dental health examination.
Experimental: Arm 3: Polysubstance Use Group
This group includes individuals who use multiple substances (polysubstance use disorder). All participants were evaluated by the same psychiatrist to ensure diagnostic accuracy. Following their psychiatric evaluation, participants had a clinical oral health examination, during which the DMFT index was calculated to assess dental health. This group is included to examine the impact of polysubstance use on oral health.
Diagnostic test: Dental caries was assessed using the DMFT index (Decayed, Missing, and Filled Teeth) according to the World Health Organization's caries diagnostic criteria.
The same psychiatrist administered the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) to all participants. Oral health examinations were performed by a trained dental student and a specialist dentist using a portable dental chair, artificial light, and a dental mirror. Dental caries was assessed using the DMFT index (Decayed, Missing, and Filled Teeth) according to the World Health Organization's caries diagnostic criteria. This index included the number of decayed, missing (due to caries, excluding 3rd molars), and filled teeth in the permanent dentition. The oral health examiners were blinded to each participant's substance use type and sociodemographic information.
Diagnostic test: Substance Use Disorder Diagnosis
This intervention involves a psychiatric evaluation conducted by a licensed psychiatrist to diagnose Substance Use Disorder according to the criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). The psychiatrist performs a comprehensive assessment of each participant's substance use history and related behaviors. This diagnosis step is essential for identifying participants with specific substance use disorders, such as Methamphetamine, Cannabis, or Polysubstance Use Disorders, before proceeding with the dental health examination.
Other: Arm 4: Control Group
Healthy, non-substance-using individuals This group consists of healthy individuals with no history of substance use, systemic medical conditions, or regular medication use. Diagnoses were confirmed by the same psychiatrist. Afterward, participants underwent a clinical oral health examination, and the DMFT index was calculated to provide a baseline for comparison with substance-using groups. This group serves as the control group to compare the dental health outcomes of non-substance-using individuals.
Diagnostic test: Dental caries was assessed using the DMFT index (Decayed, Missing, and Filled Teeth) according to the World Health Organization's caries diagnostic criteria.
The same psychiatrist administered the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) to all participants. Oral health examinations were performed by a trained dental student and a specialist dentist using a portable dental chair, artificial light, and a dental mirror. Dental caries was assessed using the DMFT index (Decayed, Missing, and Filled Teeth) according to the World Health Organization's caries diagnostic criteria. This index included the number of decayed, missing (due to caries, excluding 3rd molars), and filled teeth in the permanent dentition. The oral health examiners were blinded to each participant's substance use type and sociodemographic information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the oral health status of individuals with Methamphetamine (MA), Cannabis (THC), and Polysubstance (PSU) Use Disorders to healthy controls assessed by DMFT index
Time Frame: Up to 24 weeks
Dental caries was assessed using the DMFT index (Decayed, Missing, and Filled Teeth) according to the World Health Organization's caries diagnostic criteria. This index included the number of decayed, missing (due to caries, excluding 3rd molars), and filled teeth in the permanent dentition. A minimum score of 0 and a maximum score of 28 can be obtained on the DMFT scale, with higher scores indicating poorer oral health.
Up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Izmir Democracy University

Investigators

  • Study Director: Osman HT Kılıç, Asist. Prof., Izmir Democracy University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 25, 2024

Primary Completion (Actual)

August 25, 2024

Study Completion (Actual)

August 25, 2024

Study Registration Dates

First Submitted

October 9, 2024

First Submitted That Met QC Criteria

October 11, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 11, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/234

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Due to the sensitive nature of the data, individual participant data (IPD) will be shared only with researchers who sign a data use agreement. This agreement will stipulate the purpose of data usage, ensuring that the data will be used solely for scientific research and not for any non-research purposes.

IPD Sharing Time Frame

The IPD and supporting information will be available after the study has been published in an international peer-reviewed journal and will remain accessible for five years following publication.

IPD Sharing Access Criteria

ccess will be granted to qualified researchers who provide a scientific rationale for data usage and agree to sign a data use agreement. This agreement will stipulate that the data will be used exclusively for scientific research purposes

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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