<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/NCT04487665</url>
  </required_header>
  <id_info>
    <org_study_id>8791</org_study_id>
    <nct_id>NCT04487665</nct_id>
  </id_info>
  <brief_title>Oral Manifestations of Coronavirus Disease 2019(COVID-19) :a Multicentre Study</brief_title>
  <official_title>Oral Manifestations of COVID-19: a Multicentre Observational Study</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      online questionnaire will be distributed in different country to detect the oral change in&#xD;
      patient diagnosed with COVID-19&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      an online survey will be performed through google form. Investigators in different country&#xD;
      will share the questionnaire with patient diagnosed positive COVID-19.&#xD;
&#xD;
      data collected will be statically analyse to detect the oral picture of the virus.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 15, 2020</start_date>
  <completion_date type="Anticipated">December 15, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 15, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>oral ulcer</measure>
    <time_frame>through study completion, an average of 1 month</time_frame>
    <description>number of patient with oral ulcer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>hyposalivation</measure>
    <time_frame>through study completion, an average of 1 month</time_frame>
    <description>change in salivary flow</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Covid19</condition>
  <arm_group>
    <arm_group_label>positive COVID-19</arm_group_label>
    <description>patient diagnosed by nasopharyngeal positive COVID-19</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        patient with no previous serious illness - from different country&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  positive COVID-19&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  children&#xD;
&#xD;
          -  patient not confirmed by swab&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
  </eligibility>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>July 23, 2020</last_update_submitted>
  <last_update_submitted_qc>July 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Dina mounir elkady</investigator_full_name>
    <investigator_title>lecturer at conservative department</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Oral Manifestations</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>data will be on a private mail , no access will be provided except for principal investigator</ipd_description>
  </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/NCT04487665
org study id: 8791
nct id: NCT04487665
lead sponsor: 
has dmc: No
online questionnaire will be distributed in different country to detect the oral change in
      patient diagnosed with COVID-19
an online survey will be performed through google form. Investigators in different country
      will share the questionnaire with patient diagnosed positive COVID-19.

      data collected will be statically analyse to detect the oral picture of the virus.
observational model: Ecologic or Community
time perspective: Cross-Sectional
measure: oral ulcer
time frame: through study completion, an average of 1 month
description: number of patient with oral ulcer
measure: hyposalivation
time frame: through study completion, an average of 1 month
description: change in salivary flow
arm group label: positive COVID-19
description: patient diagnosed by nasopharyngeal positive COVID-19
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Dina mounir elkady
investigator title: lecturer at conservative department
mesh term: COVID-19
mesh term: Oral Manifestations
sharing ipd: No
ipd description: data will be on a private mail , no access will be provided except for principal investigator