<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/NCT03789565</url>
  </required_header>
  <id_info>
    <org_study_id>hepcidin</org_study_id>
    <nct_id>NCT03789565</nct_id>
  </id_info>
  <brief_title>Hepcidin Levels in Periodontal Health and Disease</brief_title>
  <official_title>Gingival Crevicular Fluid and Serum Levels of Hepcidin, IL-6 and IL-10 in Periodontal Health and Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bulent Ecevit University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bulent Ecevit 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 disease refers to inflammatory disease of the periodontium caused by the host&#xD;
      and/or pathogenic microorganisms. Anti-inflammatory and pro-inflammatory cytokines play a&#xD;
      role in the periodontal inflammation process. The aim of this study was to evaluate the&#xD;
      levels of hepcidin, interleukin (IL)-6, and IL-10 levels in gingival crevicular fluid (GCF)&#xD;
      and in serum samples obtained from individuals with periodontal inflammation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study included 90 individuals, who were divided into three groups: periodontally healthy&#xD;
      (PH) (n=30); gingivitis (G) (n=30); and chronic periodontitis (CP) (n=30). GCF and serum&#xD;
      samples were obtained from each individual, and samples were evaluated using ELISA.&#xD;
      Statistical evaluation of the data was performed using the SPSS packet data program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 15, 2017</start_date>
  <completion_date type="Actual">February 15, 2018</completion_date>
  <primary_completion_date type="Actual">January 20, 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>3 Days</target_duration>
  <primary_outcome>
    <measure>Hepcidin levels</measure>
    <time_frame>1 year</time_frame>
    <description>Change in inflammatory phases</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>IL-6 levels</measure>
    <time_frame>1 year</time_frame>
    <description>Change in inflammatory phases</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IL-10 levels</measure>
    <time_frame>1 year</time_frame>
    <description>Change in inflammatory phases</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">90</enrollment>
  <condition>Periodontal Diseases</condition>
  <arm_group>
    <arm_group_label>Group 1. Healthy individuals from periodontal perspective:</arm_group_label>
    <description>GI &lt; 1, PD ≤ 3 mm, CAL = 0 mm, with no apparent bone loss on radiography.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2. Individuals diagnosed with Gingivitis</arm_group_label>
    <description>GI &gt; 1, PD ≤ 3 mm, CAL = 0 mm, with no apparent bone loss on radiography.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3. Individuals diagnosed with CP</arm_group_label>
    <description>GI &gt; 1, PD ≥ 5 mm, CAL ≥ 3 mm, with apparent bone loss on radiography.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Biomarker test</intervention_name>
    <description>Diagnostic biomarker study</description>
    <arm_group_label>Group 1. Healthy individuals from periodontal perspective:</arm_group_label>
    <arm_group_label>Group 2. Individuals diagnosed with Gingivitis</arm_group_label>
    <arm_group_label>Group 3. Individuals diagnosed with CP</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Gingival crevicular fluid and Serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The study included a total of 60 individuals between 32 and 52 years of age, with a total&#xD;
        number of teeth &gt; 20, who underwent consultation for periodontal treatment&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Systematically healthy patients. Patients who did not receive any medication or&#xD;
             periodontal treatment within the previous 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals who smoked and women who were pregnant and/or lactating were excluded from&#xD;
             the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>32 Years</minimum_age>
    <maximum_age>52 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Çiğdem Coşkun Türer</name>
      <address>
        <city>Zonguldak</city>
        <zip>67600</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>December 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <last_update_submitted>October 2, 2019</last_update_submitted>
  <last_update_submitted_qc>October 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bulent Ecevit University</investigator_affiliation>
    <investigator_full_name>ÇİĞDEM COŞKUN TÜRER</investigator_full_name>
    <investigator_title>clinical associate professor, DDS, PhD</investigator_title>
  </responsible_party>
  <keyword>periodontal diseases</keyword>
  <keyword>hepcidin</keyword>
  <keyword>elisa</keyword>
  <keyword>interleukin 6</keyword>
  <keyword>interleukin 10</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontal Diseases</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/NCT03789565
org study id: hepcidin
nct id: NCT03789565
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Periodontal disease refers to inflammatory disease of the periodontium caused by the host
      and/or pathogenic microorganisms. Anti-inflammatory and pro-inflammatory cytokines play a
      role in the periodontal inflammation process. The aim of this study was to evaluate the
      levels of hepcidin, interleukin (IL)-6, and IL-10 levels in gingival crevicular fluid (GCF)
      and in serum samples obtained from individuals with periodontal inflammation.
The study included 90 individuals, who were divided into three groups: periodontally healthy
      (PH) (n=30); gingivitis (G) (n=30); and chronic periodontitis (CP) (n=30). GCF and serum
      samples were obtained from each individual, and samples were evaluated using ELISA.
      Statistical evaluation of the data was performed using the SPSS packet data program.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Hepcidin levels
time frame: 1 year
description: Change in inflammatory phases
measure: IL-6 levels
time frame: 1 year
description: Change in inflammatory phases
measure: IL-10 levels
time frame: 1 year
description: Change in inflammatory phases
arm group label: Group 1. Healthy individuals from periodontal perspective:
description: GI < 1, PD ≤ 3 mm, CAL = 0 mm, with no apparent bone loss on radiography.
arm group label: Group 2. Individuals diagnosed with Gingivitis
description: GI > 1, PD ≤ 3 mm, CAL = 0 mm, with no apparent bone loss on radiography.
arm group label: Group 3. Individuals diagnosed with CP
description: GI > 1, PD ≥ 5 mm, CAL ≥ 3 mm, with apparent bone loss on radiography.
intervention type: Other
intervention name: Biomarker test
description: Diagnostic biomarker study
arm group label: Group 1. Healthy individuals from periodontal perspective:
arm group label: Group 2. Individuals diagnosed with Gingivitis
arm group label: Group 3. Individuals diagnosed with CP
Gingival crevicular fluid and Serum
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 32 Years
maximum age: 52 Years
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Bulent Ecevit University
investigator full name: ÇİĞDEM COŞKUN TÜRER
investigator title: clinical associate professor, DDS, PhD
mesh term: Periodontal Diseases
sharing ipd: No