<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/NCT04402996</url>
  </required_header>
  <id_info>
    <org_study_id>Sağlık Bilimleri Üniversitesi</org_study_id>
    <nct_id>NCT04402996</nct_id>
  </id_info>
  <brief_title>Meteorin-like Levels in Individuals With Periodontitis</brief_title>
  <official_title>Evaluation of Meteorin-like Levels in Individuals With Healthy and Periodontal Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul Saglik Bilimleri University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul Saglik Bilimleri 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>
      Metrnl has proven to be an inflammatory-related immunoregulatory cytokine and shown to play a&#xD;
      role in the pathogenesis of human inflammatory diseases. Metrnl is highly expressed from the&#xD;
      oral mucosa to the esophagus. Periodontitis is a chronic inflammatory disease that can start&#xD;
      with localized inflammatory reactions created by the supporting tissues surrounding the teeth&#xD;
      against microorganisms and then result in loss of teeth. The authors think that Metrnl may&#xD;
      play a role in the periodontitis. The aim of this study is to compare the Metrnl, TNF-α,&#xD;
      IL-1β, TGF-β, IL-10 and VEGF levels of healthy and periodontitis individuals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Periodontitis is a destructive chronic inflammatory disease that can start with localized&#xD;
      inflammatory reactions created by the supporting tissues surrounding the teeth against&#xD;
      microorganisms and then result in loss of teeth. Cytokines play an important role in&#xD;
      inflammation that occurs in periodontal disease.&#xD;
&#xD;
      Tumor Necrosis Factor-α (TNF-α), Interleukine -1β ( IL-1β )and Interleukine-6 (IL-6),&#xD;
      Prostaglandin E2 (PGE2) and Interferon gamma (IFN- γ) levels are associated with periodontal&#xD;
      destruction in the pathogenesis of periodontal disease. Vascular endothelial growth factor&#xD;
      (VEGF) are important features of inflammation, wound healing and bone healing. Cytokines such&#xD;
      as Interleukine-10 (IL-10) and transforming growth factor- β (TGF-β) have been reported to&#xD;
      decrease periodontal disease progression rate.&#xD;
&#xD;
      Gingival crevicular fluid shows the cellular response in the periodontium. The most important&#xD;
      host-related ingredients are inflammatory markers, including cytokines, enzymes, and&#xD;
      interleukins. Saliva analysis is used in the diagnosis of systemic conditions as well as in&#xD;
      the diagnosis of oral pathologies.&#xD;
&#xD;
      Meteorin- like (Metrnl) is a protein that plays a role in natural and acquired immune-related&#xD;
      functions and inflammatory responses, and expressed in barrier tissues (skin and mucosa) as&#xD;
      well as various macrophage populations, from dendritic cells and some granulocytes. Metrnl&#xD;
      has proven to be an inflammatory-related immunoregulatory cytokine and shown to play a role&#xD;
      in the pathogenesis of human inflammatory diseases. Metrnl, which is highly expressed from&#xD;
      the oral mucosa to the esophagus, may play a role in the onset of periodontitis and an&#xD;
      effective marker in preventing the progression of destruction. We think that Metrnl plays an&#xD;
      important role in periodontitis, an inflammatory disease. The aim of this study is to compare&#xD;
      the Metrnl, TNF-α, IL-1β, TGF-β, IL-10 and VEGF levels of healthy and periodontitis&#xD;
      individuals&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 23, 2019</start_date>
  <completion_date type="Actual">March 3, 2021</completion_date>
  <primary_completion_date type="Actual">March 3, 2021</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>TNF-α</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>saliva and serum levels</description>
  </primary_outcome>
  <primary_outcome>
    <measure>IL-1β</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>saliva and serum levels</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Metrnl</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>saliva and serum levels</description>
  </primary_outcome>
  <primary_outcome>
    <measure>IL-10 levels</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>saliva and serum levels</description>
  </primary_outcome>
  <primary_outcome>
    <measure>saliva VEGF</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>saliva and serum levels</description>
  </primary_outcome>
  <primary_outcome>
    <measure>TGF-β</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>saliva and serum levels</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plaque Index</measure>
    <time_frame>up to 20 weeks</time_frame>
    <description>Silness-Löe</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Probing Depth</measure>
    <time_frame>up to 20 weeks</time_frame>
    <description>millimeter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding on Probe</measure>
    <time_frame>up to 20 weeks</time_frame>
    <description>Ainamo&amp;Bay</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">53</enrollment>
  <condition>Periodontitis</condition>
  <condition>Gingivitis</condition>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Healthy</arm_group_label>
    <description>Individuals with Periodontally Healthy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gingivitis</arm_group_label>
    <description>Individuals with Gingival Inflammation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Periodontitis</arm_group_label>
    <description>Individuals with Periodontitis</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Saliva</intervention_name>
    <description>individuals' saliva samples will be collected and transferred to eppendorf tubes.&#xD;
Until biochemical analysis is carried out will be stored in -80ºC.</description>
    <arm_group_label>Gingivitis</arm_group_label>
    <arm_group_label>Healthy</arm_group_label>
    <arm_group_label>Periodontitis</arm_group_label>
    <other_name>sampling</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>gingival crevicular fluid</intervention_name>
    <description>GCF samples of individuals will be collected by paper strips and transferred to eppendorf tubes.&#xD;
Until biochemical analysis is carried out will be stored in -80ºC.</description>
    <arm_group_label>Gingivitis</arm_group_label>
    <arm_group_label>Healthy</arm_group_label>
    <arm_group_label>Periodontitis</arm_group_label>
    <other_name>sampling</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Gingival Crevicular Fluid and Saliva&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals will be divided into three different groups, about 20-25 people in each group.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  systemically healthy&#xD;
&#xD;
          -  individuals who does not have a disease under treatment,&#xD;
&#xD;
          -  individuals without regular systemic medication&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  smoking&#xD;
&#xD;
          -  receiving periodontal treatment in the last 6 months&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  menopausal or menstrual period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ayşe Toraman, Dr.</last_name>
    <role>Study Chair</role>
    <affiliation>Saglik Bilimleri Universitesi</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Serhat Köseoğlu, assoc prof</last_name>
    <role>Study Chair</role>
    <affiliation>Saglik Bilimleri Universitesi</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mehmet Sağlam, assoc prof</last_name>
    <role>Study Chair</role>
    <affiliation>Izmir Katip Celebi University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Levent Savran, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Izmir Katip Celebi University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ebru Sağlam, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Saglik Bilimleri Universitesi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ebru Sağlam</name>
      <address>
        <city>İstanbul</city>
        <state>Eyalet/Yerleşke</state>
        <zip>34668</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>October 17, 2021</last_update_submitted>
  <last_update_submitted_qc>October 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul Saglik Bilimleri University</investigator_affiliation>
    <investigator_full_name>Ebru SAĞLAM</investigator_full_name>
    <investigator_title>Principal Investigator,Health Sciences University, Dentistry Faculty</investigator_title>
  </responsible_party>
  <keyword>Meteorin-like</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gingivitis</mesh_term>
    <mesh_term>Periodontitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04402996
org study id: Sağlık Bilimleri Üniversitesi
nct id: NCT04402996
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Metrnl has proven to be an inflammatory-related immunoregulatory cytokine and shown to play a
      role in the pathogenesis of human inflammatory diseases. Metrnl is highly expressed from the
      oral mucosa to the esophagus. Periodontitis is a chronic inflammatory disease that can start
      with localized inflammatory reactions created by the supporting tissues surrounding the teeth
      against microorganisms and then result in loss of teeth. The authors think that Metrnl may
      play a role in the periodontitis. The aim of this study is to compare the Metrnl, TNF-α,
      IL-1β, TGF-β, IL-10 and VEGF levels of healthy and periodontitis individuals.
Periodontitis is a destructive chronic inflammatory disease that can start with localized
      inflammatory reactions created by the supporting tissues surrounding the teeth against
      microorganisms and then result in loss of teeth. Cytokines play an important role in
      inflammation that occurs in periodontal disease.

      Tumor Necrosis Factor-α (TNF-α), Interleukine -1β ( IL-1β )and Interleukine-6 (IL-6),
      Prostaglandin E2 (PGE2) and Interferon gamma (IFN- γ) levels are associated with periodontal
      destruction in the pathogenesis of periodontal disease. Vascular endothelial growth factor
      (VEGF) are important features of inflammation, wound healing and bone healing. Cytokines such
      as Interleukine-10 (IL-10) and transforming growth factor- β (TGF-β) have been reported to
      decrease periodontal disease progression rate.

      Gingival crevicular fluid shows the cellular response in the periodontium. The most important
      host-related ingredients are inflammatory markers, including cytokines, enzymes, and
      interleukins. Saliva analysis is used in the diagnosis of systemic conditions as well as in
      the diagnosis of oral pathologies.

      Meteorin- like (Metrnl) is a protein that plays a role in natural and acquired immune-related
      functions and inflammatory responses, and expressed in barrier tissues (skin and mucosa) as
      well as various macrophage populations, from dendritic cells and some granulocytes. Metrnl
      has proven to be an inflammatory-related immunoregulatory cytokine and shown to play a role
      in the pathogenesis of human inflammatory diseases. Metrnl, which is highly expressed from
      the oral mucosa to the esophagus, may play a role in the onset of periodontitis and an
      effective marker in preventing the progression of destruction. We think that Metrnl plays an
      important role in periodontitis, an inflammatory disease. The aim of this study is to compare
      the Metrnl, TNF-α, IL-1β, TGF-β, IL-10 and VEGF levels of healthy and periodontitis
      individuals
observational model: Other
time perspective: Cross-Sectional
measure: TNF-α
time frame: through study completion, an average of 6 months
description: saliva and serum levels
measure: IL-1β
time frame: through study completion, an average of 6 months
description: saliva and serum levels
measure: Metrnl
time frame: through study completion, an average of 6 months
description: saliva and serum levels
measure: IL-10 levels
time frame: through study completion, an average of 6 months
description: saliva and serum levels
measure: saliva VEGF
time frame: through study completion, an average of 6 months
description: saliva and serum levels
measure: TGF-β
time frame: through study completion, an average of 6 months
description: saliva and serum levels
measure: Plaque Index
time frame: up to 20 weeks
description: Silness-Löe
measure: Probing Depth
time frame: up to 20 weeks
description: millimeter
measure: Bleeding on Probe
time frame: up to 20 weeks
description: Ainamo&Bay
arm group label: Healthy
description: Individuals with Periodontally Healthy
arm group label: Gingivitis
description: Individuals with Gingival Inflammation
arm group label: Periodontitis
description: Individuals with Periodontitis
intervention type: Other
intervention name: Saliva
description: individuals' saliva samples will be collected and transferred to eppendorf tubes.
Until biochemical analysis is carried out will be stored in -80ºC.
arm group label: Gingivitis
arm group label: Healthy
arm group label: Periodontitis
other name: sampling
intervention type: Other
intervention name: gingival crevicular fluid
description: GCF samples of individuals will be collected by paper strips and transferred to eppendorf tubes.
Until biochemical analysis is carried out will be stored in -80ºC.
arm group label: Gingivitis
arm group label: Healthy
arm group label: Periodontitis
other name: sampling
Gingival Crevicular Fluid and Saliva
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ayşe Toraman, Dr.
role: Study Chair
affiliation: Saglik Bilimleri Universitesi
last name: Serhat Köseoğlu, assoc prof
role: Study Chair
affiliation: Saglik Bilimleri Universitesi
last name: Mehmet Sağlam, assoc prof
role: Study Chair
affiliation: Izmir Katip Celebi University
last name: Levent Savran, PhD
role: Study Chair
affiliation: Izmir Katip Celebi University
last name: Ebru Sağlam, Dr
role: Principal Investigator
affiliation: Saglik Bilimleri Universitesi
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Istanbul Saglik Bilimleri University
investigator full name: Ebru SAĞLAM
investigator title: Principal Investigator,Health Sciences University, Dentistry Faculty
mesh term: Gingivitis
mesh term: Periodontitis
sharing ipd: No