<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/NCT01675336</url>
  </required_header>
  <id_info>
    <org_study_id>ILI-11-129-PST2Taiwan</org_study_id>
    <nct_id>NCT01675336</nct_id>
  </id_info>
  <brief_title>Genetics of Periodontal Diseases in Chinese (Taiwan)</brief_title>
  <official_title>The Association Between Interleukin-1 Gene Variations and Adult Chronic Periodontal Disease in Chinese (Taiwan))</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kaohsiung Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Interleukin Genetics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Kaohsiung Medical University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A retrospective case control study to validate the association between Interleukin-1 gene&#xD;
      variations and adult chronic periodontal disease in Chinese (Taiwan).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>August 2011</start_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Periodontal Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All study subjects will be selected from a pre-existing patient database in Taiwan. All&#xD;
        chronic periodontitis cases and controls will be subjects who were at least 35 years old at&#xD;
        time of enrollment.&#xD;
&#xD;
        Classification of chronic periodontitis will be based on the extent of periodontal tissue&#xD;
        destruction with consideration of tooth loss.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  To be included in this study, an individual needs to be Han Chinese of 35 years of age&#xD;
             or older at time of enrollment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who, at time of enrollment, were pregnant or breastfeeding, or needed&#xD;
             antibiotic prophylaxis before periodontal treatment will be excluded from this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ya-Ping Ho, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>employee</affiliation>
  </overall_official>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 27, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <last_update_submitted>August 28, 2012</last_update_submitted>
  <last_update_submitted_qc>August 28, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 29, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kaohsiung Medical University</investigator_affiliation>
    <investigator_full_name>Ya-Ping Ho</investigator_full_name>
    <investigator_title>Assistant 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/NCT01675336
org study id: ILI-11-129-PST2Taiwan
nct id: NCT01675336
lead sponsor: 
collaborator: 
has dmc: No
A retrospective case control study to validate the association between Interleukin-1 gene
      variations and adult chronic periodontal disease in Chinese (Taiwan).
observational model: Case-Control
time perspective: Retrospective
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 35 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ya-Ping Ho, Ph.D.
role: Principal Investigator
affiliation: employee
responsible party type: Principal Investigator
investigator affiliation: Kaohsiung Medical University
investigator full name: Ya-Ping Ho
investigator title: Assistant Professor
mesh term: Periodontal Diseases