Temporomandibular DisorderNCT05985733
Evaluation of Oxidative Stress and Inflammation Markers in Temporomandibular Disorders
An observational study of Temporomandibular Disorder and Oxidative Stress, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial summary
Background: The occurrence of many diseases has been associated with oxidative stress and disruption of antioxidant mechanisms. Temporomandibular Joint(TMJ) Disorders are also thought to develop with the onset of the destructive process in the tissues as a result of this balance being disrupted. Read more about this study
- Who is it for?
- Ages 14 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Disorder, Oxidative Stress, Inflammation
- What is being tested?
- Biochemical analysis
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Jun 2020to 19 Apr 2023
- Phase
- Observational
- 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 14 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: TMD subjects who had RDC/TMD type II disorder (TMJ disc displacement (DD) with reduction, TMJ-DD without reduction with limited opening, TMJ-DD without reduction without limited opening) and, age and sex matched volunteers were included as the control group
Who may be able to join
- TMD subjects who had RDC/TMD type II disorder (TMJ disc displacement (DD) with reduction
- TMJ-DD without reduction with limited opening
- TMJ-DD without reduction without limited opening)
Who cannot join
- other local or systemic diseases,
- pain of dental origin,
- pregnancy or lactation,
- story of the use of anti-inflammatory drugs, analgesics, muscle relaxants, vitamin C or vitamin E,
- smoking,
- individuals who had already been under treatment for TMD
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bahcesehir University
Istanbul, Beşiktaş, 34357
About this study
Official title: The Evaluation of Oxidative Stress and Inflammation Markers in Serum and Saliva of the Patients With Temporomandibular Disorders
Background: The occurrence of many diseases has been associated with oxidative stress and disruption of antioxidant mechanisms. Temporomandibular Joint(TMJ) Disorders are also thought to develop with the onset of the destructive process in the tissues as a result of this balance being disrupted.
Purpose: This study was designed to compare salivary and serum oxidative stress and inflammation markers of individuals with Temporomandibular Disorders (TMD) and healthy subjects.
Read more
Study design, setting, and sample: A prospective cross-sectional study was conducted. 27 TMD patients diagnosed with disc displacement (DD) according to RDC/TMD and 17 healthy subjects were enrolled in the study. Prior to any treatment, serum and saliva samples were taken from the patients and centrifuged, and stored at -80°C until analyzed. All samples were examined for IL-6, MDA and 8-OHdG concentrations.
Predictor variable: Diagnosis of disc displacement (RDC/TMD) Main outcome variables: Levels of 8-OHdG, IL-6 and MDA Covariates: Age and gender
Read the detailed description
The term oxidative stress is defined as any condition that causes free radical accumulation in tissue. Oxidative stress, which is an indicator of the deterioration of the balance between oxidant/antioxidant in an organism, is thought to play a role in the pathogenesis of various diseases such as atherosclerosis, aging, cancer, neurological disorders, diabetes, ischemia/reperfusion, Alzheimer's, Parkinson's, rheumatoid arthritis and chronic inflammation. Recently, many studies have shown a relationship between the pathogenesis of TMD and various free radicals, antioxidant enzymes and inflammation mediators. Through biomolecule methods studies determine the increase of some of cytokines such as Interleukin 1β (IL-1β), IL-6 in TMJ with internal derangement. These studies emphasize the positive relationship between the severity of the disease and the levels of synovial fluid mediators in joints with TMD. Although it has been supported by previous studies that synovial fluid is a reliable diagnostic material-that reflects the pathological condition in the joint, the disadvantages of the difficulty of obtaining has led to the need for the use of another realiable diagnostic tool. Saliva and blood are materials that are easily available and provide information about the formation and etiology of many systemic diseases.
The aim of this study is to compare the salivary and serum oxidative stress and inflammatory marker levels of TMD patients with RDC/TMD type II disorder with healthy subjects. For this purpose, IL-6, MDA and 8-OHdG will be evaluated as biomarkers of inflammation and oxidative stress.
- Conditions
- Temporomandibular Disorder, Oxidative Stress, Inflammation
- Being tested
- Biochemical analysis
- Medical subject headings
- Temporomandibular Joint Disorders, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biochemical analysisOther
Oxidative stress and inflammation markers were analyzed in serum and saliva of TMD and healthy subjects.
| Study group | Role | What they receive |
|---|---|---|
| Study group | patients who applied to our clinic with complaint of pain in TMJ region subjects who had RDC/TMD type II disorder Receives: Other: Biochemical analysis | |
| Control group | age and sex matched healthy volunteers Receives: Other: Biochemical analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
relationship between serum and salivary 8-OHdG, IL-6 and MDA levels
relationship between serum and salivary 8-OHdG, IL-6 and MDA levels and Temporomandibular Disorders were evaluated
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start19 Jun 2020
- Primary completion28 Mar 2023
- Study completion19 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisorderStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilara KAZAN, Bahçeşehir University
- Investigators
- Dilara Kazan, Principal investigator, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05985733
- Sponsor's protocol ID
- PYO.DIS.1904.17.018
- Status last verified
- Aug 2023
- First submitted
- 26 Jul 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Oxidative Stress and Inflammation Markers in Serum and Saliva of the Patients With Temporomandibular Disorders
- ClinicalTrials.gov ID
- NCT05985733
- Acronym / sponsor ID
- PYO.DIS.1904.17.018
- Conditions
- Temporomandibular Disorder, Oxidative Stress, Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 19 Jun 2020 (actual)
- Primary completion
- 28 Mar 2023 (actual)
- Study completion
- 19 Apr 2023 (actual)
- First posted
- 14 Aug 2023 (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.
Background: The occurrence of many diseases has been associated with oxidative stress and disruption of antioxidant mechanisms. Temporomandibular Joint(TMJ) Disorders are also thought to develop with the onset of the destructive process in the tissues as a result of this balance being disrupted.
Purpose: This study was designed to compare salivary and serum oxidative stress and inflammation markers of individuals with Temporomandibular Disorders (TMD) and healthy subjects.
Study design, setting, and sample: A prospective cross-sectional study was conducted. 27 TMD patients diagnosed with disc displacement (DD) according to RDC/TMD and 17 healthy subjects were enrolled in the study. Prior to any treatment, serum and saliva samples were taken from the patients and centrifuged, and stored at -80°C until analyzed. All samples were examined for IL-6, MDA and 8-OHdG concentrations.
Predictor variable: Diagnosis of disc displacement (RDC/TMD) Main outcome variables: Levels of 8-OHdG, IL-6 and MDA Covariates: Age and gender
Detailed description
The term oxidative stress is defined as any condition that causes free radical accumulation in tissue. Oxidative stress, which is an indicator of the deterioration of the balance between oxidant/antioxidant in an organism, is thought to play a role in the pathogenesis of various diseases such as atherosclerosis, aging, cancer, neurological disorders, diabetes, ischemia/reperfusion, Alzheimer's, Parkinson's, rheumatoid arthritis and chronic inflammation. Recently, many studies have shown a relationship between the pathogenesis of TMD and various free radicals, antioxidant enzymes and inflammation mediators. Through biomolecule methods studies determine the increase of some of cytokines such as Interleukin 1β (IL-1β), IL-6 in TMJ with internal derangement. These studies emphasize the positive relationship between the severity of the disease and the levels of synovial fluid mediators in joints with TMD. Although it has been supported by previous studies that synovial fluid is a reliable diagnostic material-that reflects the pathological condition in the joint, the disadvantages of the difficulty of obtaining has led to the need for the use of another realiable diagnostic tool. Saliva and blood are materials that are easily available and provide information about the formation and etiology of many systemic diseases.
The aim of this study is to compare the salivary and serum oxidative stress and inflammatory marker levels of TMD patients with RDC/TMD type II disorder with healthy subjects. For this purpose, IL-6, MDA and 8-OHdG will be evaluated as biomarkers of inflammation and oxidative stress.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: Biochemical analysispatients who applied to our clinic with complaint of pain in TMJ region subjects who had RDC/TMD type II disorder |
| Control group | – | Other: Biochemical analysisage and sex matched healthy volunteers |
Who may qualify
- Ages
- 14 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- TMD subjects who had RDC/TMD type II disorder (TMJ disc displacement (DD) with reduction, TMJ-DD without reduction with limited opening, TMJ-DD without reduction without limited opening) and, age and sex matched volunteers were included as the control group
Key inclusion criteria (3 listed)
- TMD subjects who had RDC/TMD type II disorder (TMJ disc displacement (DD) with reduction
- TMJ-DD without reduction with limited opening
- TMJ-DD without reduction without limited opening)
Key exclusion criteria (6 listed)
- other local or systemic diseases,
- pain of dental origin,
- pregnancy or lactation,
- story of the use of anti-inflammatory drugs, analgesics, muscle relaxants, vitamin C or vitamin E,
- smoking,
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 |
|---|---|---|
| Biochemical analysisOxidative stress and inflammation markers were analyzed in serum and saliva of TMD and healthy subjects. | Other | Control group, Study group |
Primary outcome
relationship between serum and salivary 8-OHdG, IL-6 and MDA levels
Time frame: through study completion, an average of 1 year
relationship between serum and salivary 8-OHdG, IL-6 and MDA levels and Temporomandibular Disorders were evaluated
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 14 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Dilara Kazan principal investigator
Bahçeşehir University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Temporomandibular Disorder and Oxidative Stress, run by Bahçeşehir 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 6 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 14 Aug 2023. 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?
relationship between serum and salivary 8-OHdG, IL-6 and MDA levels (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2023.