Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05985733 |
| Other study ID # |
PYO.DIS.1904.17.018 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 19, 2020 |
| Est. completion date |
April 19, 2023 |
Study information
| Verified date |
August 2023 |
| Source |
Bahçesehir University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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.
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
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.
