- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05985733
Evaluation of Oxidative Stress and Inflammation Markers in Temporomandibular Disorders
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.
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
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Beşiktaş
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İstanbul, Beşiktaş, Turkey, 34357
- Bahçeşehir University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Study group
patients who applied to our clinic with complaint of pain in TMJ region subjects who had RDC/TMD type II disorder
|
Oxidative stress and inflammation markers were analyzed in serum and saliva of TMD and healthy subjects.
|
Control group
age and sex matched healthy volunteers
|
Oxidative stress and inflammation markers were analyzed in serum and saliva of TMD and healthy subjects.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dilara Kazan, Bahçeşehir University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PYO.DIS.1904.17.018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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