Clinical trial NCT06640712: Oral and Dental Health in Substance Dependent Individuals
Official title: The Evaluation of Oral and Dental Health in Substance Dependent Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorder (SUD)
Decayed Teeth
Teeth Loss
Teeth Missing
Keywords: substance use disorder
Oral health
DMTF index
Oral health behaviors
Lead sponsor: Izmir Democracy University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 281
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Compare the oral health status of individuals with Methamphetamine (MA), Cannabis (THC), and Polysubstance (PSU) Use Disorders to healthy controls assessed by DMFT index
timeFrame: Up to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: İzmir Demokrasi Üniversitesi
state: Konak
Study officials:
affiliation: Izmir Democracy University
name: Osman HT Kılıç, Asist. Prof.
role: STUDY_DIRECTOR
References: