NCT06640712

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
281

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 25, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

4 months

First QC Date

October 9, 2024

Last Update Submit

October 11, 2024

Conditions

Keywords

substance use disorderOral healthDMTF indexOral health behaviors

Outcome Measures

Primary Outcomes (1)

  • Compare the oral health status of individuals with Methamphetamine (MA), Cannabis (THC), and Polysubstance (PSU) Use Disorders to healthy controls assessed by DMFT index

    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

Study Arms (4)

Arm 1: Methamphetamine Use Group

EXPERIMENTAL

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.Diagnostic Test: Substance Use Disorder Diagnosis

Arm 2: Cannabis Use Group

EXPERIMENTAL

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.Diagnostic Test: Substance Use Disorder Diagnosis

Arm 3: Polysubstance Use Group

EXPERIMENTAL

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.Diagnostic Test: Substance Use Disorder Diagnosis

Arm 4: Control Group

OTHER

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.

Interventions

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.

Arm 1: Methamphetamine Use GroupArm 2: Cannabis Use GroupArm 3: Polysubstance Use GroupArm 4: Control Group

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.

Arm 1: Methamphetamine Use GroupArm 2: Cannabis Use GroupArm 3: Polysubstance Use Group

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İzmir Demokrasi Üniversitesi

Izmir, Konak, Turkey (Türkiye)

Location

Related Publications (1)

  • Kilic OHT, Kurklu Arpacay D, Gezen OC, Bayram ZN, Baser A. Comparative effects of methamphetamine, cannabis, and polysubstance use on oral health. Front Psychiatry. 2025 Jan 31;16:1510228. doi: 10.3389/fpsyt.2025.1510228. eCollection 2025.

Related Links

MeSH Terms

Conditions

Substance-Related DisordersDental CariesAnodontia

Interventions

Metabolism

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersTooth DemineralizationTooth DiseasesStomatognathic DiseasesTooth AbnormalitiesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Osman HT Kılıç, Asist. Prof.

    Izmir Democracy University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: his study uses a parallel design to compare the oral health status among individuals with different substance use disorders (Methamphetamine, Cannabis, Polysubstance) and a healthy control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asistant Profesor

Study Record Dates

First Submitted

October 9, 2024

First Posted

October 15, 2024

Study Start

April 25, 2024

Primary Completion

August 25, 2024

Study Completion

August 25, 2024

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
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.
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

Locations