<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/NCT03779763</url>
  </required_header>
  <id_info>
    <org_study_id>21252461</org_study_id>
    <nct_id>NCT03779763</nct_id>
  </id_info>
  <brief_title>Prevalence Of Periodontitis Stage III &amp; IV</brief_title>
  <official_title>Prevalence Of Periodontitis Stage III &amp;IV: A Hospital-Based Cross-Sectional Study On A Sample Of Adult Egyptian Dental 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is a cross-sectional survey investigating the prevalence of Periodontitis stage III&#xD;
      &amp; IV in Egyptian dental patients attending the oral diagnosis clinic at faculty of Dentistry,&#xD;
      Cairo University&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Since the 1999 workshop, substantial new information has emergedfrom population studies,&#xD;
      basic science investigations, and evidencefrom prospective studies evaluating environmental&#xD;
      and systemic riskfactors. The analysis of this evidence has prompted the 2017 workshopto&#xD;
      develop a new classification framework for periodontitis&#xD;
&#xD;
      In the last 30 years, the classification of periodontitis has been repeatedly upgraded in an&#xD;
      attempt to align it with emerging scientific evidence. The workshop agreed that, consistent&#xD;
      with current knowledge on pathophysiology, three forms of periodontitis can be identified:&#xD;
      necrotizing periodontitis, periodontitis as a manifestation of systemic disease and the forms&#xD;
      of the disease previously known as &quot;chronic&quot; or &quot;aggressive&quot;, now grouped under a single&#xD;
      category, &quot;periodontitis&quot;.In revising the classification, the workshop agreed on a&#xD;
      classification framework for periodontitis further characterized based on a multidimensional&#xD;
      staging and grading system that could be adapted over time as new evidence emerges&#xD;
&#xD;
      Staging is largely dependent upon the severity of disease at presentationas well as on the&#xD;
      complexity of disease management.While,grading provides supplemental information about&#xD;
      biological features of the disease, including a history based analysis of the rate of disease&#xD;
      progression, assessment of the risk for further progression, anticipated poor outcomes of&#xD;
      treatment, and assessment of the risk that the disease or its treatment may negatively affect&#xD;
      the general health of the patient&#xD;
&#xD;
      Staging involves four categories (stages 1 through 4) and is determined after considering&#xD;
      several variables including clinical attachment loss, amount and percentage of bone loss,&#xD;
      probing depth, presence and extent of angular bony defects, furcation involvement,tooth&#xD;
      mobility and tooth loss due to periodontitis.&#xD;
&#xD;
      Stage III &amp; IV are characterized by interdental clinical attatchment loss &gt; 5mm and&#xD;
      radiographic bone loss extending to the middle or apical third of the root. In stage III,&#xD;
      four teeth or less are lost while in stage IV, five teeth or more are lost due to&#xD;
      periodontitis. In addition to stage II complexity, Stage III is characterized by probing&#xD;
      depth greater than or equal 6 mm, vertical bone loss greater than or equal 3mm, furcation&#xD;
      involvement class II or III and moderate ridge defect. In addition to stage III complexity,&#xD;
      stage IV is characterized by severe ridge defect , bite collapse, drifting and flaring.&#xD;
&#xD;
      The study aims at determining the prevalence of Periodontitis Stage III &amp; IV in adult&#xD;
      Egyptian dental outpatients attending the diagnostic centre at faculty of Dentistry, Cairo&#xD;
      University&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 15, 2019</start_date>
  <completion_date type="Actual">September 15, 2019</completion_date>
  <primary_completion_date type="Actual">June 15, 2019</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>prevalence of Periodontitis stage III &amp; IV</measure>
    <time_frame>after recriutment of required sample size , through study completion an average of one year</time_frame>
  </primary_outcome>
  <enrollment type="Actual">750</enrollment>
  <condition>Periodontitis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        -  Dental patients will be recruited in a consecutive manner from the outpatient&#xD;
             Diagnostic center, Faculty of Dentistry, Cairo University.&#xD;
&#xD;
          -  Medical history will be taken, thorough oral examination will be done, and a full&#xD;
             questionnaire will be filled for each patient.&#xD;
&#xD;
          -  Before filling the questionnaire, the aim of the study will be explained to the&#xD;
             patient and the patient's acceptance to participate in the survey will be received.&#xD;
&#xD;
          -  Non-respondent patients or patients refusing to participate will be reported with the&#xD;
             cause of their refusal.&#xD;
&#xD;
          -  The questionnaire will be filled through a face-to-face personal interview with the&#xD;
             patient using simple, short, easily comprehended questions.&#xD;
&#xD;
          -  The Questionnaire will include a section for demographic information of age, sex,&#xD;
             social and educational levels of the patient. It will also include questions about&#xD;
             medical condition, habits of trauma, smoking and its frequency.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients whose age is above 15 years old.&#xD;
&#xD;
          -  Patient consulting in the outpatient clinic&#xD;
&#xD;
          -  Provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients having problem in opening their mouth or undergoing intermaxillary fixation&#xD;
             where oral examination will not be possible.&#xD;
&#xD;
          -  Patients diagnosed with psychiatric problems or intoxicated with alcohol or drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Faculty of Dentistry , Cairo Univeristy</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>December 15, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Omar Khaled Gamil Moussa Megahed</investigator_full_name>
    <investigator_title>Master postgraduate student</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>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/NCT03779763
org study id: 21252461
nct id: NCT03779763
lead sponsor: 
has dmc: Yes
The study is a cross-sectional survey investigating the prevalence of Periodontitis stage III
      & IV in Egyptian dental patients attending the oral diagnosis clinic at faculty of Dentistry,
      Cairo University
Since the 1999 workshop, substantial new information has emergedfrom population studies,
      basic science investigations, and evidencefrom prospective studies evaluating environmental
      and systemic riskfactors. The analysis of this evidence has prompted the 2017 workshopto
      develop a new classification framework for periodontitis

      In the last 30 years, the classification of periodontitis has been repeatedly upgraded in an
      attempt to align it with emerging scientific evidence. The workshop agreed that, consistent
      with current knowledge on pathophysiology, three forms of periodontitis can be identified:
      necrotizing periodontitis, periodontitis as a manifestation of systemic disease and the forms
      of the disease previously known as "chronic" or "aggressive", now grouped under a single
      category, "periodontitis".In revising the classification, the workshop agreed on a
      classification framework for periodontitis further characterized based on a multidimensional
      staging and grading system that could be adapted over time as new evidence emerges

      Staging is largely dependent upon the severity of disease at presentationas well as on the
      complexity of disease management.While,grading provides supplemental information about
      biological features of the disease, including a history based analysis of the rate of disease
      progression, assessment of the risk for further progression, anticipated poor outcomes of
      treatment, and assessment of the risk that the disease or its treatment may negatively affect
      the general health of the patient

      Staging involves four categories (stages 1 through 4) and is determined after considering
      several variables including clinical attachment loss, amount and percentage of bone loss,
      probing depth, presence and extent of angular bony defects, furcation involvement,tooth
      mobility and tooth loss due to periodontitis.

      Stage III & IV are characterized by interdental clinical attatchment loss > 5mm and
      radiographic bone loss extending to the middle or apical third of the root. In stage III,
      four teeth or less are lost while in stage IV, five teeth or more are lost due to
      periodontitis. In addition to stage II complexity, Stage III is characterized by probing
      depth greater than or equal 6 mm, vertical bone loss greater than or equal 3mm, furcation
      involvement class II or III and moderate ridge defect. In addition to stage III complexity,
      stage IV is characterized by severe ridge defect , bite collapse, drifting and flaring.

      The study aims at determining the prevalence of Periodontitis Stage III & IV in adult
      Egyptian dental outpatients attending the diagnostic centre at faculty of Dentistry, Cairo
      University
observational model: Ecologic or Community
time perspective: Cross-Sectional
measure: prevalence of Periodontitis stage III & IV
time frame: after recriutment of required sample size , through study completion an average of one year
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: N/A
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Omar Khaled Gamil Moussa Megahed
investigator title: Master postgraduate student
mesh term: Periodontitis