NCT05985733

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 19, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2023

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

2.8 years

First QC Date

July 26, 2023

Last Update Submit

August 3, 2023

Conditions

Outcome Measures

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

    through study completion, an average of 1 year

Study Arms (2)

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

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

Control groupStudy group

Eligibility Criteria

Age14 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahcesehir University

Istanbul, Beşiktaş, 34357, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

saliva serum

MeSH Terms

Conditions

Temporomandibular Joint DisordersInflammation

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dilara Kazan

    Bahçeşehir University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 26, 2023

First Posted

August 14, 2023

Study Start

June 19, 2020

Primary Completion

March 28, 2023

Study Completion

April 19, 2023

Last Updated

August 14, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations