<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/NCT03299595</url>
  </required_header>
  <id_info>
    <org_study_id>CEBC-CU-2017-08-01</org_study_id>
    <nct_id>NCT03299595</nct_id>
  </id_info>
  <brief_title>Oral Mucosal Lesions Among Smokers in an Egyptian Population.</brief_title>
  <official_title>Prevalence of Oral Mucosal Lesions Among Smokers in an Egyptian Cohort: A Hospital-based Cross-Sectional Study (II)</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>
      This cross-sectional study will assess the prevalence of oral changes among smokers in an&#xD;
      Egyptian cohort (patients attending to the hospital of Faculty of Dentistry - Cairo&#xD;
      University), aiming that this study can serve as a baseline for future studies with the goal&#xD;
      of finding ways to improve oral health and increase awareness of the hazards of smoking in&#xD;
      Egypt&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The participants will be selected from the pool of the Clinics of Oral Medicine,&#xD;
      Periodontology and Diagnosis Department and the Diagnostic center, Faculty of Dentistry -&#xD;
      Cairo University. For each eligible participant, a full history will be obtained according to&#xD;
      a questionnaire followed by thorough clinical examination.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Actual">June 30, 2019</completion_date>
  <primary_completion_date type="Actual">March 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>oral mucosal lesions</measure>
    <time_frame>one year</time_frame>
    <description>Identifying and recording oral mucosal lesions</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oral health-related quality of life (OH-QoL) evaluation</measure>
    <time_frame>one year</time_frame>
    <description>using Oral Health Impact Profile (OHIP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>histopathological evaluation</measure>
    <time_frame>one year</time_frame>
    <description>light microscope</description>
  </secondary_outcome>
  <enrollment type="Actual">824</enrollment>
  <condition>Smokers</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>printed questionnaire</intervention_name>
    <description>For each eligible participant, a full history will be obtained according to a questionnaire followed by thorough clinical examination.</description>
  </intervention>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      Histopathological evaluation of clinically suspicious oral lesions to detect dysplasia&#xD;
      (Warnakulasuriy et al., 2007 and Rastogi et al., 2013).&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The participants will be selected from the pool of the Clinics of Oral Medicine,&#xD;
        Periodontology and Diagnosis Department and the Diagnostic center, Faculty of Dentistry -&#xD;
        Cairo University. For each eligible participant, a full history will be obtained according&#xD;
        to a questionnaire followed by thorough clinical examination.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Gender: males and females.&#xD;
&#xD;
          -  Age: all age groups.&#xD;
&#xD;
          -  Smokers.&#xD;
&#xD;
          -  Individuals who agreed to sign the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals suffering from any systemic disease.&#xD;
&#xD;
          -  Individuals on medications.&#xD;
&#xD;
          -  Non-Egyptians.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Faculty of Dentistry</name>
      <address>
        <city>Cairo</city>
        <zip>11728</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>January 7, 2021</last_update_submitted>
  <last_update_submitted_qc>January 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Alaa Shousha</investigator_full_name>
    <investigator_title>resident</investigator_title>
  </responsible_party>
  <!-- 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/NCT03299595
org study id: CEBC-CU-2017-08-01
nct id: NCT03299595
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This cross-sectional study will assess the prevalence of oral changes among smokers in an
      Egyptian cohort (patients attending to the hospital of Faculty of Dentistry - Cairo
      University), aiming that this study can serve as a baseline for future studies with the goal
      of finding ways to improve oral health and increase awareness of the hazards of smoking in
      Egypt
The participants will be selected from the pool of the Clinics of Oral Medicine,
      Periodontology and Diagnosis Department and the Diagnostic center, Faculty of Dentistry -
      Cairo University. For each eligible participant, a full history will be obtained according to
      a questionnaire followed by thorough clinical examination.
observational model: Cohort
time perspective: Cross-Sectional
measure: oral mucosal lesions
time frame: one year
description: Identifying and recording oral mucosal lesions
measure: Oral health-related quality of life (OH-QoL) evaluation
time frame: one year
description: using Oral Health Impact Profile (OHIP)
measure: histopathological evaluation
time frame: one year
description: light microscope
intervention type: Other
intervention name: printed questionnaire
description: For each eligible participant, a full history will be obtained according to a questionnaire followed by thorough clinical examination.
Histopathological evaluation of clinically suspicious oral lesions to detect dysplasia
      (Warnakulasuriy et al., 2007 and Rastogi et al., 2013).
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Alaa Shousha
investigator title: resident