<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/NCT03805724</url>
  </required_header>
  <id_info>
    <org_study_id>15062006</org_study_id>
    <nct_id>NCT03805724</nct_id>
  </id_info>
  <brief_title>Entamoeba Gingivalis and Periodontal Disease</brief_title>
  <official_title>Is Entamoeba Gingivalis A Risk Factor In Periodontal Diseases</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>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>
      This current study aims to clarify the relationship between the occurrence of Entamoeba&#xD;
      gingivalis infection and the specter of gingivitis &amp; chronic periodontitis among Egyptian&#xD;
      patients in comparison to healthy volunteers as a control group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Three groups will be included in the current study. 40 Plaque samples will be collected from&#xD;
      gingivitis patients (group 1), 40 from chronic periodontitis patients (group 2) plus 40&#xD;
      samples from healthy volunteers (group 3). Diagnosis of parasitic stages will rely on direct&#xD;
      microscopic detection using permanent stains, Trichrome stain and haematoxylin and eosin&#xD;
      stain in addition to direct wet mount examination.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 13, 2018</start_date>
  <completion_date type="Actual">January 18, 2019</completion_date>
  <primary_completion_date type="Actual">January 18, 2019</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>Other</time_perspective>
  </study_design_info>
  <target_duration>2 Weeks</target_duration>
  <primary_outcome>
    <measure>Presence of Entamoaba Gingivalis parasite in dental plaque assessed by direct microscopic examination</measure>
    <time_frame>2 weeks</time_frame>
    <description>Direct microscopic detection of Entamoaba Gingivalis in dental plaque samples using Trichrome stain</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">120</enrollment>
  <condition>Periodontal Diseases</condition>
  <arm_group>
    <arm_group_label>Periodontally healthy subjects</arm_group_label>
    <description>They will be selected from healthy subjects who attend the restorative dental clinic and has clinically healthy gingiva with zero plaque index, gingival index and clinical attachment level &amp; probing depth ≤ 3 mm. Plaque samples will be collected.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chronic Periodontitis</arm_group_label>
    <description>Chronic periodontitis patients having probing depth of ≥3 mm and clinical attachment level ≥ 1 mm. Plaque samples will be collected.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chronic Gingivitis</arm_group_label>
    <description>Gingivitis patients having signs of clinical inflammation with no clinical attachment loss. Plaque samples will be collected</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Plaque Samples</intervention_name>
    <description>After carefully drying of the selected site and isolation by cotton roll, plaque samples will be collected by sweeping movement of the probe at gingival crevices of the tooth aspect with pervious inclusion criteria for obtaining of the plaque sample. Samples will be immediately dipped in sterile Eppendorf tubes containing PVA.</description>
    <arm_group_label>Chronic Gingivitis</arm_group_label>
    <arm_group_label>Chronic Periodontitis</arm_group_label>
    <arm_group_label>Periodontally healthy subjects</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Gingivitis &amp; Chronic periodontitis patients will be selected from the outpatients Clinic,&#xD;
        Department of Oral Medicine, Periodontology and Diagnosis, Faculty of Dentistry, Fayoum&#xD;
        University. Clinical examination for all patients will be performed including the following&#xD;
        periodontal parameters: plaque index, gingival index, probing depth, and clinical&#xD;
        attachment level. These measurements will be recorded by a single calibrated expert&#xD;
        examiner at six sites for all teeth (mesiobuccal, mesiolingual, midbuccal, distobuccal,&#xD;
        distolingual, and midlingual). PI is assessed by measuring the presence or absence of&#xD;
        supragingival biofilm with a sweeping movement of the probe around the surfaces of all&#xD;
        teeth&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic Gingivitis patients with signs of clinical inflammation with no clinical&#xD;
             attachment loss.&#xD;
&#xD;
          -  Chronic Periodontitis patients having probing depth of ≥3 mm and clinical attachment&#xD;
             level ≥ 1 mm.&#xD;
&#xD;
          -  The control group: healthy subjects who attend the restorative dental clinic and had&#xD;
             clinically healthy gingiva.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with any systemic diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gihane G Madkour, Ass Prof</last_name>
    <role>Study Director</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Dentistry, 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>March 2019</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>March 29, 2019</last_update_submitted>
  <last_update_submitted_qc>March 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 2, 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>Periodontal Diseases</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/NCT03805724
org study id: 15062006
nct id: NCT03805724
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This current study aims to clarify the relationship between the occurrence of Entamoeba
      gingivalis infection and the specter of gingivitis & chronic periodontitis among Egyptian
      patients in comparison to healthy volunteers as a control group.
Three groups will be included in the current study. 40 Plaque samples will be collected from
      gingivitis patients (group 1), 40 from chronic periodontitis patients (group 2) plus 40
      samples from healthy volunteers (group 3). Diagnosis of parasitic stages will rely on direct
      microscopic detection using permanent stains, Trichrome stain and haematoxylin and eosin
      stain in addition to direct wet mount examination.
observational model: Case-Control
time perspective: Other
measure: Presence of Entamoaba Gingivalis parasite in dental plaque assessed by direct microscopic examination
time frame: 2 weeks
description: Direct microscopic detection of Entamoaba Gingivalis in dental plaque samples using Trichrome stain
arm group label: Periodontally healthy subjects
description: They will be selected from healthy subjects who attend the restorative dental clinic and has clinically healthy gingiva with zero plaque index, gingival index and clinical attachment level & probing depth ≤ 3 mm. Plaque samples will be collected.
arm group label: Chronic Periodontitis
description: Chronic periodontitis patients having probing depth of ≥3 mm and clinical attachment level ≥ 1 mm. Plaque samples will be collected.
arm group label: Chronic Gingivitis
description: Gingivitis patients having signs of clinical inflammation with no clinical attachment loss. Plaque samples will be collected
intervention type: Other
intervention name: Plaque Samples
description: After carefully drying of the selected site and isolation by cotton roll, plaque samples will be collected by sweeping movement of the probe at gingival crevices of the tooth aspect with pervious inclusion criteria for obtaining of the plaque sample. Samples will be immediately dipped in sterile Eppendorf tubes containing PVA.
arm group label: Chronic Gingivitis
arm group label: Chronic Periodontitis
arm group label: Periodontally healthy subjects
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 35 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gihane G Madkour, Ass Prof
role: Study Director
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: Periodontal Diseases