ClinicalTrials.gg
CompletedNCT05985733Updated Aug 14, 2023

Evaluation of Oxidative Stress and Inflammation Markers in Temporomandibular Disorders

An observational study in Temporomandibular Disorder, Oxidative Stress and Inflammation, sponsored by Bahçeşehir University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 14 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-14.

Sponsored by Bahçeşehir University · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
44
Ages
14 Years to 40 Years
Sex
All
01

Study 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

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.

02

Conditions studied

  • Temporomandibular Disorder
  • Oxidative Stress
  • Inflammation
03

In context

Temporomandibular Joint Disorders

621 studies on the registry are indexed under Temporomandibular Joint Disorders; 161 are open to participants now.

This study's enrollment of 44 is below the median of 90 across 171 observational studies indexed under Temporomandibular Joint Disorders.

Browse Temporomandibular Joint Disorders studies →

Lead sponsor

Bahçeşehir University is the lead sponsor of 121 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
44 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Study group

    patients who applied to our clinic with complaint of pain in TMJ region subjects who had RDC/TMD type II disorder

    Other: Biochemical analysis

  • Control group

    age and sex matched healthy volunteers

    Other: Biochemical analysis

Interventions

  • OtherBiochemical analysis

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: through study completion, an average of 1 year

07

Study locations

1 site
  • Bahcesehir University
    Istanbul, Beşiktaş 34357, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2020 to primary completion in Mar 2023, 33 months.

Of 58 non-industry observational studies under Temporomandibular Joint Disorders, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 30. This study's 33 months is above that.

Counting every sponsor, half of 60 studies reached it within 13 months; a quarter within 5 and three quarters within 30.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 26, 2023
First posted
Aug 14, 2023
StartActual
Jun 19, 2020
Primary completionActual
Mar 28, 2023
CompletionActual
Apr 19, 2023
Last update
Aug 14, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05985733
Responsible party
Dilara KAZAN (Assistant Professor, Bahçeşehir University) — Principal investigator
First posted
Aug 14, 2023
Start date
Jun 19, 2020
Primary completion
Mar 28, 2023
Completion
Apr 19, 2023
Last update
Aug 14, 2023

Study contacts

Dilara Kazan
principal investigator · Bahçeşehir University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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