<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/NCT02977351</url>
  </required_header>
  <id_info>
    <org_study_id>IzmirKCU</org_study_id>
    <nct_id>NCT02977351</nct_id>
  </id_info>
  <brief_title>Determining the Relationship Between the Atherosclerosis and Periodontopathogenic Microorganisms</brief_title>
  <official_title>Determining the Relationship Between the Atherosclerosis and Periodontopathogenic Microorganisms in Chronic Periodontitis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Izmir Katip Celebi University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Izmir Katip Celebi University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Determine the relationship between the systemic indications of atherosclerosis by means of&#xD;
      the change in the ratio of periodontopathogenic microorganisms following periodontal&#xD;
      treatment of individuals who have been diagnosed with chronic periodontitis-atherosclerosis&#xD;
      and for individuals who have been diagnosed with systemically healthy-chronic periodontitis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It has been aimed in this study to compare 1) the change in periodontal status; 2) the change&#xD;
      of the periodontopathogen microorganisms (A. actinomycetemcomitans, P. gingivalis, T.&#xD;
      forsythia, T. denticola, P. intermedia, P. micros, F. nucleatum/periodonticum, C. rectus, E.&#xD;
      nodatum, E. corrodens, and C. gingivalis/ochracea/sputigena) in dental plaque samples, 3) the&#xD;
      changes of the amounts of HDL, LDL, hs-CRP white blood cell levels (WBC), platelet levels&#xD;
      (PLT), creatinine, and fibrinogen in serum samples; and 4) the correlation between&#xD;
      periodontopathogen microorganisms (A. actinomycetemcomitans, P. gingivalis, T. forsythia, T.&#xD;
      denticola, P. intermedia, P. micros, F. nucleatum/periodonticum, C. rectus, E. nodatum, E.&#xD;
      corrodens, and C. gingivalis/ochracea/sputigena) and HDL, LDL, hs-CRP WBC, PLT, creatinine,&#xD;
      and fibrinogen in patients that have been diagnosed with atherosclerosis-chronic&#xD;
      periodontitis and systemic healthy patients and patients diagnosed with chronic&#xD;
      periodontitis, following non surgical periodontal treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Periodontopathogenic microorganism levels</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Atherosclerosis</condition>
  <condition>Chronic Periodontitis</condition>
  <arm_group>
    <arm_group_label>Atherosclerosis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with atherosclerosis and chronic periodontitis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Systemically healthy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with Systemically healthy and chronic periodontitis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Non-surgical periodontal treatment</intervention_name>
    <arm_group_label>Atherosclerosis</arm_group_label>
    <arm_group_label>Systemically healthy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  had no systemic disease,&#xD;
&#xD;
          -  had not used any antibiotics&#xD;
&#xD;
          -  had not used medications with an impact on the immune system,&#xD;
&#xD;
          -  had not received any periodontal and/or medical treatment within the last 6 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  smokers of cigarettes or other tobacco products,&#xD;
&#xD;
          -  pregnant or breastfeeding,&#xD;
&#xD;
          -  non-stable cardiovascular condition.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 15, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>November 29, 2016</last_update_submitted>
  <last_update_submitted_qc>November 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Izmir Katip Celebi University</investigator_affiliation>
    <investigator_full_name>Dr. A. Seckin ERTUGRUL</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Periodontopathogenic microorganisms</keyword>
  <keyword>Non-surgical periodontal treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontitis</mesh_term>
    <mesh_term>Chronic Periodontitis</mesh_term>
    <mesh_term>Atherosclerosis</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/NCT02977351
org study id: IzmirKCU
nct id: NCT02977351
lead sponsor: 
has dmc: No
Determine the relationship between the systemic indications of atherosclerosis by means of
      the change in the ratio of periodontopathogenic microorganisms following periodontal
      treatment of individuals who have been diagnosed with chronic periodontitis-atherosclerosis
      and for individuals who have been diagnosed with systemically healthy-chronic periodontitis.
It has been aimed in this study to compare 1) the change in periodontal status; 2) the change
      of the periodontopathogen microorganisms (A. actinomycetemcomitans, P. gingivalis, T.
      forsythia, T. denticola, P. intermedia, P. micros, F. nucleatum/periodonticum, C. rectus, E.
      nodatum, E. corrodens, and C. gingivalis/ochracea/sputigena) in dental plaque samples, 3) the
      changes of the amounts of HDL, LDL, hs-CRP white blood cell levels (WBC), platelet levels
      (PLT), creatinine, and fibrinogen in serum samples; and 4) the correlation between
      periodontopathogen microorganisms (A. actinomycetemcomitans, P. gingivalis, T. forsythia, T.
      denticola, P. intermedia, P. micros, F. nucleatum/periodonticum, C. rectus, E. nodatum, E.
      corrodens, and C. gingivalis/ochracea/sputigena) and HDL, LDL, hs-CRP WBC, PLT, creatinine,
      and fibrinogen in patients that have been diagnosed with atherosclerosis-chronic
      periodontitis and systemic healthy patients and patients diagnosed with chronic
      periodontitis, following non surgical periodontal treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Periodontopathogenic microorganism levels
time frame: 1 year
arm group label: Atherosclerosis
arm group type: Experimental
description: Patients with atherosclerosis and chronic periodontitis
arm group label: Systemically healthy
arm group type: Active Comparator
description: Patients with Systemically healthy and chronic periodontitis.
intervention type: Procedure
intervention name: Non-surgical periodontal treatment
arm group label: Atherosclerosis
arm group label: Systemically healthy
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Izmir Katip Celebi University
investigator full name: Dr. A. Seckin ERTUGRUL
investigator title: Principal Investigator
mesh term: Periodontitis
mesh term: Chronic Periodontitis
mesh term: Atherosclerosis
sharing ipd: No