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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.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date April 19, 2023
Est. primary completion date March 28, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Biochemical analysis
Oxidative stress and inflammation markers were analyzed in serum and saliva of TMD and healthy subjects.

Locations

Country Name City State
Turkey Bahcesehir University Istanbul Besiktas

Sponsors (1)

Lead Sponsor Collaborator
Bahçesehir University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 through study completion, an average of 1 year
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