xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05985733</url>
    </required_header>
    <id_info>
      <org_study_id>PYO.DIS.1904.17.018</org_study_id>
      <nct_id>NCT05985733</nct_id>
    </id_info>
    <brief_title>Evaluation of Oxidative Stress and Inflammation Markers in Temporomandibular Disorders</brief_title>
    <official_title>The Evaluation of Oxidative Stress and Inflammation Markers in Serum and Saliva of the Patients With Temporomandibular Disorders</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bahçeşehir University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Bahçeşehir University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Background: The occurrence of many diseases has been associated with oxidative stress and&#xD;
        disruption of antioxidant mechanisms. Temporomandibular Joint(TMJ) Disorders are also thought&#xD;
        to develop with the onset of the destructive process in the tissues as a result of this&#xD;
        balance being disrupted.&#xD;
  &#xD;
        Purpose: This study was designed to compare salivary and serum oxidative stress and&#xD;
        inflammation markers of individuals with Temporomandibular Disorders (TMD) and healthy&#xD;
        subjects.&#xD;
  &#xD;
        Study design, setting, and sample: A prospective cross-sectional study was conducted. 27 TMD&#xD;
        patients diagnosed with disc displacement (DD) according to RDC/TMD and 17 healthy subjects&#xD;
        were enrolled in the study. Prior to any treatment, serum and saliva samples were taken from&#xD;
        the patients and centrifuged, and stored at -80°C until analyzed. All samples were examined&#xD;
        for IL-6, MDA and 8-OHdG concentrations.&#xD;
  &#xD;
        Predictor variable: Diagnosis of disc displacement (RDC/TMD) Main outcome variables: Levels&#xD;
        of 8-OHdG, IL-6 and MDA Covariates: Age and gender&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The term oxidative stress is defined as any condition that causes free radical accumulation&#xD;
        in tissue. Oxidative stress, which is an indicator of the deterioration of the balance&#xD;
        between oxidant/antioxidant in an organism, is thought to play a role in the pathogenesis of&#xD;
        various diseases such as atherosclerosis, aging, cancer, neurological disorders, diabetes,&#xD;
        ischemia/reperfusion, Alzheimer's, Parkinson's, rheumatoid arthritis and chronic&#xD;
        inflammation. Recently, many studies have shown a relationship between the pathogenesis of&#xD;
        TMD and various free radicals, antioxidant enzymes and inflammation mediators. Through&#xD;
        biomolecule methods studies determine the increase of some of cytokines such as Interleukin&#xD;
        1β (IL-1β), IL-6 in TMJ with internal derangement. These studies emphasize the positive&#xD;
        relationship between the severity of the disease and the levels of synovial fluid mediators&#xD;
        in joints with TMD. Although it has been supported by previous studies that synovial fluid is&#xD;
        a reliable diagnostic material-that reflects the pathological condition in the joint, the&#xD;
        disadvantages of the difficulty of obtaining has led to the need for the use of another&#xD;
        realiable diagnostic tool. Saliva and blood are materials that are easily available and&#xD;
        provide information about the formation and etiology of many systemic diseases.&#xD;
  &#xD;
        The aim of this study is to compare the salivary and serum oxidative stress and inflammatory&#xD;
        marker levels of TMD patients with RDC/TMD type II disorder with healthy subjects. For this&#xD;
        purpose, IL-6, MDA and 8-OHdG will be evaluated as biomarkers of inflammation and oxidative&#xD;
        stress.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 19, 2020</start_date>
    <completion_date type="Actual">April 19, 2023</completion_date>
    <primary_completion_date type="Actual">March 28, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>relationship between serum and salivary 8-OHdG, IL-6 and MDA levels</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>relationship between serum and salivary 8-OHdG, IL-6 and MDA levels and Temporomandibular Disorders were evaluated</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">44</enrollment>
    <condition>Temporomandibular Disorder</condition>
    <condition>Oxidative Stress</condition>
    <condition>Inflammation</condition>
    <arm_group>
      <arm_group_label>Study group</arm_group_label>
      <description>patients who applied to our clinic with complaint of pain in TMJ region subjects who had RDC/TMD type II disorder</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <description>age and sex matched healthy volunteers</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Biochemical analysis</intervention_name>
      <description>Oxidative stress and inflammation markers were analyzed in serum and saliva of TMD and healthy subjects.</description>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_label>Study group</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        saliva serum&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          TMD subjects who had RDC/TMD type II disorder (TMJ disc displacement (DD) with reduction,&#xD;
          TMJ-DD without reduction with limited opening, TMJ-DD without reduction without limited&#xD;
          opening) and, age and sex matched volunteers were included as the control group&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  TMD subjects who had RDC/TMD type II disorder (TMJ disc displacement (DD) with&#xD;
               reduction&#xD;
  &#xD;
            -  TMJ-DD without reduction with limited opening&#xD;
  &#xD;
            -  TMJ-DD without reduction without limited opening)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  other local or systemic diseases,&#xD;
  &#xD;
            -  pain of dental origin,&#xD;
  &#xD;
            -  pregnancy or lactation,&#xD;
  &#xD;
            -  story of the use of anti-inflammatory drugs, analgesics, muscle relaxants, vitamin C&#xD;
               or vitamin E,&#xD;
  &#xD;
            -  smoking,&#xD;
  &#xD;
            -  individuals who had already been under treatment for TMD&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>14 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Dilara Kazan</last_name>
      <role>Principal Investigator</role>
      <affiliation>Bahçeşehir University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Bahcesehir University</name>
        <address>
          <city>İstanbul</city>
          <state>Beşiktaş</state>
          <zip>34357</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Bahçeşehir University</investigator_affiliation>
      <investigator_full_name>Dilara KAZAN</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Temporomandibular Joint Disorders</mesh_term>
      <mesh_term>Temporomandibular Joint Dysfunction Syndrome</mesh_term>
      <mesh_term>Inflammation</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05985733
  org study id: PYO.DIS.1904.17.018
  nct id: NCT05985733
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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
  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.
  observational model: Other
  time perspective: Prospective
  measure: relationship between serum and salivary 8-OHdG, IL-6 and MDA levels
  time frame: through study completion, an average of 1 year
  description: relationship between serum and salivary 8-OHdG, IL-6 and MDA levels and Temporomandibular Disorders were evaluated
  arm group label: Study group
  description: patients who applied to our clinic with complaint of pain in TMJ region subjects who had RDC/TMD type II disorder
  arm group label: Control group
  description: age and sex matched healthy volunteers
  intervention type: Other
  intervention name: Biochemical analysis
  description: Oxidative stress and inflammation markers were analyzed in serum and saliva of TMD and healthy subjects.
  arm group label: Control group
  arm group label: Study group
  saliva serum
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 14 Years
  maximum age: 40 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Dilara Kazan
  role: Principal Investigator
  affiliation: Bahçeşehir University
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Bahçeşehir University
  investigator full name: Dilara KAZAN
  investigator title: Assistant Professor
  mesh term: Temporomandibular Joint Disorders
  mesh term: Temporomandibular Joint Dysfunction Syndrome
  mesh term: Inflammation
  sharing ipd: No