<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/NCT03008317</url>
  </required_header>
  <id_info>
    <org_study_id>CEBC-CU-2016-12-164</org_study_id>
    <nct_id>NCT03008317</nct_id>
  </id_info>
  <brief_title>Microbial Adhesion to Metallic Versus Non Metallic Surfaces of Bounded Removable Partial Denture</brief_title>
  <acronym>splitmouth</acronym>
  <official_title>Microbial Adhesion to Metallic Versus Non Metallic Surfaces of Bounded Removable Partial Denture</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>
      a split mouth randomized clinical trial that compares quantity and quality of bacterial&#xD;
      adhesion under both PEEK versus cobalt chromium alloy denture base.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      this study aimed to compare the adhesion of microorganisms to the non metallic denture base&#xD;
      of PEEK and metallic denture base of cobalt chromium alloy in patients with class III&#xD;
      modification 1&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>September 2016</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">October 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>microbial culture using number of clonies after insertion by 3 months</measure>
    <time_frame>one year</time_frame>
    <description>microbial adhesion will be measured using continous cultures to assess number of colonies</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">2</enrollment>
  <condition>Polyetheretherketone</condition>
  <arm_group>
    <arm_group_label>non metallic</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>PEEK denture base,</description>
  </arm_group>
  <arm_group>
    <arm_group_label>metallic denture base</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>cobalt chromium alloy denture base</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PEEK</intervention_name>
    <description>a metallic denture base</description>
    <arm_group_label>metallic denture base</arm_group_label>
    <arm_group_label>non metallic</arm_group_label>
    <other_name>polyetheretherketone denture base</other_name>
    <other_name>cobalt chromium alloy denture base</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients are medically free&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with badly broken abutments&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>December 30, 2016</last_update_submitted>
  <last_update_submitted_qc>December 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Hager essam el azizi</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tissue Adhesions</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chromium</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03008317
org study id: CEBC-CU-2016-12-164
nct id: NCT03008317
lead sponsor: 
has dmc: Yes
a split mouth randomized clinical trial that compares quantity and quality of bacterial
      adhesion under both PEEK versus cobalt chromium alloy denture base.
this study aimed to compare the adhesion of microorganisms to the non metallic denture base
      of PEEK and metallic denture base of cobalt chromium alloy in patients with class III
      modification 1
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: microbial culture using number of clonies after insertion by 3 months
time frame: one year
description: microbial adhesion will be measured using continous cultures to assess number of colonies
arm group label: non metallic
arm group type: Active Comparator
description: PEEK denture base,
arm group label: metallic denture base
arm group type: Placebo Comparator
description: cobalt chromium alloy denture base
intervention type: Device
intervention name: PEEK
description: a metallic denture base
arm group label: metallic denture base
arm group label: non metallic
other name: polyetheretherketone denture base
other name: cobalt chromium alloy denture base
criteria: 
gender: All
minimum age: 40 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Hager essam el azizi
investigator title: Dr
mesh term: Tissue Adhesions
mesh term: Chromium
sharing ipd: Undecided