<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/NCT03264846</url>
  </required_header>
  <id_info>
    <org_study_id>EbSAGLAM1</org_study_id>
    <nct_id>NCT03264846</nct_id>
  </id_info>
  <brief_title>Endocan Levels at Polycystic Ovary Syndrome and Periodontal Inflammation</brief_title>
  <official_title>The Levels of Interleukin-6 and Endocan at Individuals With Polycystic Ovary Syndrome and Periodontal Inflammation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ebru Saglam</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ataturk University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Bezmialem Vakif 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>
      Periodontal diseases are chronic inflammatory disease occurred by the interaction between&#xD;
      pathogenic microorganism and the host defense. Polycystic ovary syndrome (PCOS) is a&#xD;
      reproductive and metabolic disease associated with increased risk of cardiovascular events.&#xD;
      Endocan is a proteoglycan secreted mainly by endothelial cells under the control of&#xD;
      inflammatory cytokines.&#xD;
&#xD;
      Periodontal diseases, including gingivitis, are common chronic infectious diseases caused by&#xD;
      predominantly pathogenic microorganisms that colonize the subgingival area and cause local&#xD;
      and systemic elevations of proinflammatory cytokines such as Interleukin-6 (IL-6).&#xD;
&#xD;
      Several lines of evidence established the association between periodontal and systemic&#xD;
      diseases, including metabolic syndrome, diabetes, and cardiovascular disease.&#xD;
&#xD;
      Because of the fact that both periodontal disease and PCOS are associated with systemic&#xD;
      inflammation and insulin resistance, these two disorders may be linked through a common&#xD;
      pathophysiologic pathway.&#xD;
&#xD;
      A number of studies have indicated a possible relationship between PCOS and periodontal&#xD;
      inflammation. Despite common risk factors, including oxidative stress, the relationship&#xD;
      between chronic periodontitis (CP) and PCOS remains unclear.&#xD;
&#xD;
      The aims of the study were to determine serum and saliva Endocan and IL-6 levels and to&#xD;
      evaluate the correlation between these two biomarker in women with periodontal disease and&#xD;
      PCOS.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 3, 2017</start_date>
  <completion_date type="Actual">November 29, 2017</completion_date>
  <primary_completion_date type="Actual">November 29, 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Serum and salivary Endocan levels</measure>
    <time_frame>one year</time_frame>
    <description>Enzyme-Linked Immunosorbent Assay (ELISA)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum and salivary interleukin-6 levels</measure>
    <time_frame>one year</time_frame>
    <description>Enzyme-Linked Immunosorbent Assay (ELISA)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical attachment level (CAL)</measure>
    <time_frame>one year</time_frame>
    <description>Periodontal measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Probing pocket depth (PD)</measure>
    <time_frame>one year</time_frame>
    <description>Periodontal measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gingival Index</measure>
    <time_frame>One year</time_frame>
    <description>Periodontal measurement</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">87</enrollment>
  <condition>Polycystic Ovary Syndrome</condition>
  <condition>Inflammation Gum</condition>
  <condition>Cytokines</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <description>PCOS participants with periodontitis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <description>PCOS participants with periodontally healthy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <description>systemically healthy participants with periodontitis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 4</arm_group_label>
    <description>systemically and periodontally healthy participants</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Collection of Serum and Saliva Samples</intervention_name>
    <description>Whole saliva samples were obtained via expectorating into polypropylene tubes venous blood were obtained from the antecubital vein via the standard venipuncture method.</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_label>Group 4</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum and Saliva&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All participants were included among women at the Department of Obstetrics and Gynecology,&#xD;
        School of Medicine and Department of Periodontology, Faculty of Dentistry , Ataturk&#xD;
        University&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newly diagnosed PCOS patients&#xD;
&#xD;
          -  Never smokers&#xD;
&#xD;
          -  Had no history of systemic disease&#xD;
&#xD;
          -  BMI&lt;25 kg/m2&#xD;
&#xD;
          -  Participants had ≥20 teeth present.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Lactation&#xD;
&#xD;
          -  Hemoglobin A1c (HbA1c) ≥ 6.5%&#xD;
&#xD;
          -  2-h oral glucose tolerance test (OGTT-2h) ≥200&#xD;
&#xD;
          -  Cushing syndrome, non-classic congenital adrenal hyperplasia, hyperprolactinemia,&#xD;
             thyroid dysfunction, and androgen-secreting tumors&#xD;
&#xD;
          -  Using antibiotics and antiinflammatory within the past 6 months&#xD;
&#xD;
          -  Periodontal treatment within the past 6 months&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Only women were included to study.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ebru Sağlam, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Bezmialem Vakif University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ayşe Toraman</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ataturk University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Engin Şebin</last_name>
    <role>Principal Investigator</role>
    <affiliation>Erzurum Regional Training and Research Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Cenk Fatih Çanakçı, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Ataturk University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hümeyra Çanakçı, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Private Practice</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Metin İngeç, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Ataturk University</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>February 2020</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>February 7, 2020</last_update_submitted>
  <last_update_submitted_qc>February 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Bezmialem Vakif University</investigator_affiliation>
    <investigator_full_name>Ebru Saglam</investigator_full_name>
    <investigator_title>Principal Investigator, Bezmialem Universitesi, Dentistry Faculty</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gingivitis</mesh_term>
    <mesh_term>Polycystic Ovary Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03264846
org study id: EbSAGLAM1
nct id: NCT03264846
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Periodontal diseases are chronic inflammatory disease occurred by the interaction between
      pathogenic microorganism and the host defense. Polycystic ovary syndrome (PCOS) is a
      reproductive and metabolic disease associated with increased risk of cardiovascular events.
      Endocan is a proteoglycan secreted mainly by endothelial cells under the control of
      inflammatory cytokines.

      Periodontal diseases, including gingivitis, are common chronic infectious diseases caused by
      predominantly pathogenic microorganisms that colonize the subgingival area and cause local
      and systemic elevations of proinflammatory cytokines such as Interleukin-6 (IL-6).

      Several lines of evidence established the association between periodontal and systemic
      diseases, including metabolic syndrome, diabetes, and cardiovascular disease.

      Because of the fact that both periodontal disease and PCOS are associated with systemic
      inflammation and insulin resistance, these two disorders may be linked through a common
      pathophysiologic pathway.

      A number of studies have indicated a possible relationship between PCOS and periodontal
      inflammation. Despite common risk factors, including oxidative stress, the relationship
      between chronic periodontitis (CP) and PCOS remains unclear.

      The aims of the study were to determine serum and saliva Endocan and IL-6 levels and to
      evaluate the correlation between these two biomarker in women with periodontal disease and
      PCOS.
observational model: Other
time perspective: Cross-Sectional
measure: Serum and salivary Endocan levels
time frame: one year
description: Enzyme-Linked Immunosorbent Assay (ELISA)
measure: Serum and salivary interleukin-6 levels
time frame: one year
description: Enzyme-Linked Immunosorbent Assay (ELISA)
measure: Clinical attachment level (CAL)
time frame: one year
description: Periodontal measurement
measure: Probing pocket depth (PD)
time frame: one year
description: Periodontal measurement
measure: Gingival Index
time frame: One year
description: Periodontal measurement
arm group label: Group 1
description: PCOS participants with periodontitis
arm group label: Group 2
description: PCOS participants with periodontally healthy
arm group label: Group 3
description: systemically healthy participants with periodontitis
arm group label: Group 4
description: systemically and periodontally healthy participants
intervention type: Diagnostic Test
intervention name: Collection of Serum and Saliva Samples
description: Whole saliva samples were obtained via expectorating into polypropylene tubes venous blood were obtained from the antecubital vein via the standard venipuncture method.
arm group label: Group 1
arm group label: Group 2
arm group label: Group 3
arm group label: Group 4
Serum and Saliva
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Only women were included to study.
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ebru Sağlam, PhD
role: Study Director
affiliation: Bezmialem Vakif University
last name: Ayşe Toraman
role: Principal Investigator
affiliation: Ataturk University
last name: Engin Şebin
role: Principal Investigator
affiliation: Erzurum Regional Training and Research Hospital
last name: Cenk Fatih Çanakçı, Professor
role: Study Chair
affiliation: Ataturk University
last name: Hümeyra Çanakçı, Dr
role: Principal Investigator
affiliation: Private Practice
last name: Metin İngeç, Professor
role: Study Director
affiliation: Ataturk University
facility: 
country: Turkey
responsible party type: Sponsor-Investigator
investigator affiliation: Bezmialem Vakif University
investigator full name: Ebru Saglam
investigator title: Principal Investigator, Bezmialem Universitesi, Dentistry Faculty
mesh term: Gingivitis
mesh term: Polycystic Ovary Syndrome
mesh term: Syndrome
mesh term: Inflammation
sharing ipd: Undecided