<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/NCT03803176</url>
  </required_header>
  <id_info>
    <org_study_id>12081976</org_study_id>
    <nct_id>NCT03803176</nct_id>
  </id_info>
  <brief_title>Tissue Plasminogen Activator &amp; Plasminogen Activator Inhibitor Type-1 In Gingival Tissues Of Chronic Periodontitis</brief_title>
  <official_title>Effect Of Periodontal Surgery On Tissue Plasminogen Activator And Plasminogen Activator Inhibitor Type-1 Gene Expression In Gingival Tissues Of Chronic Periodontitis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Tissue Plasminogen Activator and Plasminogen Activator Inhibitor Type-1 Gene Expression will&#xD;
      be evaluated clinically and histopathologically through Hematoxylin and eosin as well as by&#xD;
      quantitative reverse transcription polymerase chain reaction in the gingival tissues of&#xD;
      chronic periodontitis in an attempt to investigate whether the expression of these proteins&#xD;
      could be involved in the disease pathogenesis or not, and to assess as well if their&#xD;
      expression will be affected by the applied surgical periodontal treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      30 subjects were enrolled in this study and divided into: Group I (Control Group): 10&#xD;
      periodontally healthy volunteers, Group II (Chronic Periodontitis Group): 20 patients&#xD;
      suffering severe CP and Group III (Treated Group): 20 patients who were scheduled for OFD.&#xD;
      Gingival samples were collected from all subjects at baseline and at 3 months after OFD from&#xD;
      the CP patients. Then, Hematoxylin and eosin (H&amp;E) stained slides were examined and gene&#xD;
      expression levels of t-PA and PAI-1 were measured in the gingiva through quantitative reverse&#xD;
      transcription polymerase chain reaction (RT-PCR).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 12, 2018</start_date>
  <completion_date type="Actual">August 14, 2018</completion_date>
  <primary_completion_date type="Actual">June 11, 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>Prospective</time_perspective>
  </study_design_info>
  <target_duration>4 Months</target_duration>
  <primary_outcome>
    <measure>Clinical attachment level</measure>
    <time_frame>4 weeks</time_frame>
    <description>CAL</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Chronic Periodontitis</condition>
  <arm_group>
    <arm_group_label>Periodontally healthy subjects</arm_group_label>
    <description>Healthy subjects who attended the restorative dental clinic and have clinically healthy gingiva with zero plaque index (PI), gingival index (GI), and CAL (≤3 mm PD). Oral hygeine instructions will be given to these patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chronic Periodontitis</arm_group_label>
    <description>Patients with severe Chronic Periodontitis having a pocket depth (PD) of ≥5 mm and a clinical attachment level (CAL) ≥5 mm. Open flap debridement (surgical periodontal therapy) will be carried out for these patients after scaling &amp; root planing.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Open Flap Debridement</intervention_name>
    <description>Full thickness flaps are elevated to fully expose the periodontaldefects. Defects are then fully debrided and the roots are carefully planned. Flaps are repositioned and sutured to obtain primary closure of the interdental space. This will be done for chronic periodontitis patients</description>
    <arm_group_label>Chronic Periodontitis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Study population includes 30 subjects recruited from the outpatient clinic of Oral Medicine&#xD;
        &amp; Periodontology department, Faculty of Dentistry, Cairo University. Ages range from 30-50&#xD;
        years old.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with severe chronic periodontitis&#xD;
&#xD;
          -  Pocket depth (PD) of ≥5 mm&#xD;
&#xD;
          -  Clinical attachment level (CAL) ≥5 mm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Subjects taking any type of medication and/or antibiotic therapy during the 3 months&#xD;
             before the study&#xD;
&#xD;
          -  Subjects who received periodontal treatment within the past 6 months&#xD;
&#xD;
          -  Smokers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gihane G Madkour, Ass Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cairo University</name>
      <address>
        <city>Cairo</city>
        <zip>12411</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>January 11, 2019</last_update_submitted>
  <last_update_submitted_qc>January 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Gihane Gharib Madkour</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontitis</mesh_term>
    <mesh_term>Chronic Periodontitis</mesh_term>
  </condition_browse>
  <!-- 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/NCT03803176
org study id: 12081976
nct id: NCT03803176
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Tissue Plasminogen Activator and Plasminogen Activator Inhibitor Type-1 Gene Expression will
      be evaluated clinically and histopathologically through Hematoxylin and eosin as well as by
      quantitative reverse transcription polymerase chain reaction in the gingival tissues of
      chronic periodontitis in an attempt to investigate whether the expression of these proteins
      could be involved in the disease pathogenesis or not, and to assess as well if their
      expression will be affected by the applied surgical periodontal treatment.
30 subjects were enrolled in this study and divided into: Group I (Control Group): 10
      periodontally healthy volunteers, Group II (Chronic Periodontitis Group): 20 patients
      suffering severe CP and Group III (Treated Group): 20 patients who were scheduled for OFD.
      Gingival samples were collected from all subjects at baseline and at 3 months after OFD from
      the CP patients. Then, Hematoxylin and eosin (H&E) stained slides were examined and gene
      expression levels of t-PA and PAI-1 were measured in the gingiva through quantitative reverse
      transcription polymerase chain reaction (RT-PCR).
observational model: Case-Control
time perspective: Prospective
measure: Clinical attachment level
time frame: 4 weeks
description: CAL
arm group label: Periodontally healthy subjects
description: Healthy subjects who attended the restorative dental clinic and have clinically healthy gingiva with zero plaque index (PI), gingival index (GI), and CAL (≤3 mm PD). Oral hygeine instructions will be given to these patients.
arm group label: Chronic Periodontitis
description: Patients with severe Chronic Periodontitis having a pocket depth (PD) of ≥5 mm and a clinical attachment level (CAL) ≥5 mm. Open flap debridement (surgical periodontal therapy) will be carried out for these patients after scaling & root planing.
intervention type: Procedure
intervention name: Open Flap Debridement
description: Full thickness flaps are elevated to fully expose the periodontaldefects. Defects are then fully debrided and the roots are carefully planned. Flaps are repositioned and sutured to obtain primary closure of the interdental space. This will be done for chronic periodontitis patients
arm group label: Chronic Periodontitis
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 30 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gihane G Madkour, Ass Prof
role: Principal Investigator
affiliation: Cairo University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Gihane Gharib Madkour
investigator title: Associate Professor
mesh term: Periodontitis
mesh term: Chronic Periodontitis