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Completed

NCT Number: NCT05985733

Evaluation of Oxidative Stress and Inflammation Markers in 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

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Key information

Age range

14 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bahcesehir University

Istanbul, Beşiktaş, 34357, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biochemical analysis

Other

Oxidative stress and inflammation markers were analyzed in serum and saliva of TMD and healthy subjects.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Bahçeşehir University

Other

Registry information

Official study title

The Evaluation of Oxidative Stress and Inflammation Markers in Serum and Saliva of the Patients With Temporomandibular Disorders

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 14, 2023
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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