Substance Use Disorder (SUD)ODH_SUDNCT06640712
Oral and Dental Health in Substance Dependent Individuals
A study testing Dental caries was assessed using the DMFT index (Decayed, Missing, and Filled Teeth) according to the World Health Organization's caries diagnostic criteria. and Substance Use Disorder Diagnosis in people with Substance Use Disorder (SUD) and Decayed Teeth, run by Izmir Democracy University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Substance Use Disorder (SUD), Decayed Teeth, Teeth Loss
- What is being tested?
- Dental caries was assessed using the DMFT index (Decayed, Missing, and Filled Teeth) according to the World Health Organization's caries diagnostic criteria. and Substance Use Disorder Diagnosis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 281 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Apr 2024to 25 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male participants
- aged 18 to 45
- methamphetamine, cannabis, or polysubstance users.
Who cannot join
- 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
Show all 9Show fewer
- incomplete scales and forms.
- who wore removable dentures
- In the control group, individuals with a history of any substance use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Substance Use Disorder (SUD), Decayed Teeth, Teeth Loss, Teeth Missing
- Being tested
- Dental caries was assessed using the DMFT index (Decayed, Missing, and Filled Teeth) according to the World Health Organization's caries diagnostic criteria., Substance Use Disorder Diagnosis
- Keywords
- substance use disorder, Oral health, DMTF index, Oral health behaviors
- Medical subject headings
- Substance-Related Disorders, Dental Caries, Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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.
Substance Use Disorder DiagnosisDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start25 Apr 2024
- Primary completion25 Aug 2024
- Study completion25 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance Use Disorder (SUD)Studies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Democracy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan Tahsin Kilic, Buca Seyfi Demirsoy State Hospital
- Investigators
- Osman HT Kılıç, Asist. Prof., Study director, Izmir Democracy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06640712
- Sponsor's protocol ID
- 2024/234
- Acronym
- ODH_SUD
- Status last verified
- Oct 2024
- First submitted
- 9 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39958156
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Oral and Dental Health in Substance Dependent Individuals
- ClinicalTrials.gov ID
- NCT06640712
- Acronym / sponsor ID
- ODH_SUD / 2024/234
- Conditions
- Substance Use Disorder (SUD), Decayed Teeth, Teeth Loss, Teeth Missing
- Keywords
- substance use disorder, Oral health, DMTF index, Oral health behaviors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- Izmir Democracy UniversityUniversity, hospital or other
- Study start
- 25 Apr 2024 (actual)
- Primary completion
- 25 Aug 2024 (actual)
- Study completion
- 25 Aug 2024 (actual)
- First posted
- 15 Oct 2024 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Methamphetamine Use Group | Experimental | 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 DiagnosisThis 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. |
| Arm 2: Cannabis Use Group | Experimental | 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 DiagnosisThis 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. |
| Arm 3: Polysubstance Use Group | Experimental | 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 DiagnosisThis 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. |
| Arm 4: Control Group | Other | 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.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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male participants
- aged 18 to 45
- methamphetamine, cannabis, or polysubstance users.
Key exclusion criteria (9 listed)
- 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
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 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 | Arm 1: Methamphetamine Use Group, Arm 2: Cannabis Use Group, Arm 3: Polysubstance Use Group, Arm 4: Control Group |
| Substance Use Disorder DiagnosisThis 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. | Diagnostic test | Arm 1: Methamphetamine Use Group, Arm 2: Cannabis Use Group, Arm 3: Polysubstance Use Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Derived from this study: PubMed 39958156Kilic 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.
- The study was conducted at the İzmir Democracy University Buca Seyfi Demirsoy Education and Research Hospital's Probation Clinic (Denetimli Serbestlik Polikliniği). This clinic provides treatment and evaluation services for individuals who have been manLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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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. This study is not recruiting at the moment.
Osman HT Kılıç, Asist. Prof. study director
Izmir Democracy University
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 caries was assessed using the DMFT index (Decayed, Missing, and Filled Teeth) according to the World Health Organization's caries diagnostic criteria. and Substance Use Disorder Diagnosis in people with Substance Use Disorder (SUD) and Decayed Teeth, run by Izmir Democracy University at 1 site in Turkey (Türkiye).
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 3 inclusion and 9 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: finished, as of the sponsor's last update on 15 Oct 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06640712, which also lists 1 linked publication.
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 15 Oct 2024.