<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/NCT03829059</url>
  </required_header>
  <id_info>
    <org_study_id>GCG</org_study_id>
    <nct_id>NCT03829059</nct_id>
  </id_info>
  <brief_title>Histological/ Immunohistological and Molecularpathological Types of Epulides and Central Giant Cell Lesions of the Jaws</brief_title>
  <official_title>Retrospective Clinico-pathological Examinations on Different Histological/ Immunohistological and Molecularpathological Types of Epulides and Central Giant Cell Lesions of the Jaws</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Graz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Graz</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 retrospective study will evaluate the patient collective of the Division of Oral Surgery&#xD;
      and Orthodontics, Department of Dental Medicine and Oral Health and of the Division of&#xD;
      Cranio-Maxillofacial Surgery at the Medical University Graz concerning the frequency of&#xD;
      epulis/giant cell lesion or underlying differential diagnoses and immunophenotypes as well as&#xD;
      the resulting treatment methods and their success and compare these with international&#xD;
      results&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Different histopathological differential diagnoses can underlay the clinical presentation of&#xD;
      an epulis. Often the immunophenotype of these lesions is of particular importance. This also&#xD;
      holds for the the central giant cell lesion.&#xD;
&#xD;
      This study will evaluate the patient collective of the Division of Oral Surgery and&#xD;
      Orthodontics, Department of Dental Medicine and Oral Health and of the Division of&#xD;
      Cranio-Maxillofacial Surgery at the Medical University Graz concerning the frequency of&#xD;
      epulis/giant cell lesion or underlying differential diagnoses and immunophenotypes as well as&#xD;
      the resulting treatment methods and their success and compare these with international&#xD;
      results.&#xD;
&#xD;
      This is a retrospective study using electronic patient records, written records, operative&#xD;
      reports of the Division of Oral Surgery and Orthodontics, Department of Dental Medicine and&#xD;
      Oral Health and of the Division of Cranio-Maxillofacial Surgery at the Medical University&#xD;
      Graz in the period from 1986 to March 2018. It is intended to gather the data within 12&#xD;
      months and analyze statistically subsequently.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Anticipated">February 2023</completion_date>
  <primary_completion_date type="Anticipated">February 2023</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of histological pathological differential diagnoses.</measure>
    <time_frame>time period of evaluation from 1986 to March 2018</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of immunohistochemical pathological differential diagnoses.</measure>
    <time_frame>time period: from 1986 to March 2018</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of molecular pathological differential diagnoses.</measure>
    <time_frame>time period from 1986 to March 2018</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of recurrences</measure>
    <time_frame>time period from 1986 to March 2018</time_frame>
    <description>depending on differential diagnoses and therapy</description>
  </secondary_outcome>
  <enrollment type="Actual">83</enrollment>
  <condition>Epulis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The patient cohort comprises 101 patients treated in the outpatient clinic for diseases of&#xD;
        oral mucosa of the Division of Oral Surgery and Orthodontics, Department of Dental Medicine&#xD;
        and Oral Health and of the Division of Cranio-Maxillofacial Surgery at the Medical&#xD;
        University Graz in the period from 1986 to March 2018.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  existence of a medical history and a histopathological finding of the surgical&#xD;
             specimen&#xD;
&#xD;
          -  patients treated in the outpatient clinic for diseases of oral mucosa of the Division&#xD;
             of Oral Surgery and Orthodontics, Department of Dental Medicine and Oral Health and of&#xD;
             the Division of Cranio-Maxillofacial Surgery at the Medical University Graz between&#xD;
             1986 and March 2018&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  absence of a medical history or a histopathological finding.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Medical University</name>
      <address>
        <city>Graz</city>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>February 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>April 5, 2022</last_update_submitted>
  <last_update_submitted_qc>April 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gingival 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/NCT03829059
org study id: GCG
nct id: NCT03829059
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This retrospective study will evaluate the patient collective of the Division of Oral Surgery
      and Orthodontics, Department of Dental Medicine and Oral Health and of the Division of
      Cranio-Maxillofacial Surgery at the Medical University Graz concerning the frequency of
      epulis/giant cell lesion or underlying differential diagnoses and immunophenotypes as well as
      the resulting treatment methods and their success and compare these with international
      results
Different histopathological differential diagnoses can underlay the clinical presentation of
      an epulis. Often the immunophenotype of these lesions is of particular importance. This also
      holds for the the central giant cell lesion.

      This study will evaluate the patient collective of the Division of Oral Surgery and
      Orthodontics, Department of Dental Medicine and Oral Health and of the Division of
      Cranio-Maxillofacial Surgery at the Medical University Graz concerning the frequency of
      epulis/giant cell lesion or underlying differential diagnoses and immunophenotypes as well as
      the resulting treatment methods and their success and compare these with international
      results.

      This is a retrospective study using electronic patient records, written records, operative
      reports of the Division of Oral Surgery and Orthodontics, Department of Dental Medicine and
      Oral Health and of the Division of Cranio-Maxillofacial Surgery at the Medical University
      Graz in the period from 1986 to March 2018. It is intended to gather the data within 12
      months and analyze statistically subsequently.
observational model: Cohort
time perspective: Retrospective
measure: Frequency of histological pathological differential diagnoses.
time frame: time period of evaluation from 1986 to March 2018
measure: Frequency of immunohistochemical pathological differential diagnoses.
time frame: time period: from 1986 to March 2018
measure: Frequency of molecular pathological differential diagnoses.
time frame: time period from 1986 to March 2018
measure: Frequency of recurrences
time frame: time period from 1986 to March 2018
description: depending on differential diagnoses and therapy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 7 Years
maximum age: 95 Years
healthy volunteers: No
facility: 
country: Austria
responsible party type: Sponsor
mesh term: Gingival Diseases