<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/NCT03777345</url>
  </required_header>
  <id_info>
    <org_study_id>CEBD-CU-2018-11-28</org_study_id>
    <nct_id>NCT03777345</nct_id>
  </id_info>
  <brief_title>Comparison Between Injection Molded Polyetheretherketone (PEEK) Framework and Cobalt Chromium Framework Removable Partial Dentures Regarding Periodontal Health of Abutment Teeth</brief_title>
  <official_title>Evaluation of Periodontal Health of the Abutment Teeth in Partial Dentures Made of Injection Molded PEEK Framework Versus Cobalt Chromium Framework in Mandibular Kennedy Class I Edentulous Cases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is aiming to evaluate the periodontal status of the abutment teeth in&#xD;
      Polyetheretherketone ( PEEK ) framework partial dentures compared with cobalt-chromium ones&#xD;
      in mandibular kennedy class I edentulous cases aiming to preserve the optimum periodontal&#xD;
      health of the abutment teeth .&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 1, 2019</start_date>
  <completion_date type="Anticipated">July 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2019</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>Periodontal status</measure>
    <time_frame>Change in periodontal status will be assessed at base line , after one month and after 3 months .</time_frame>
    <description>periodontal status of the abutment teeth assessed by a periodontal chart .</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Mandibular Prosthesis User</condition>
  <arm_group>
    <arm_group_label>cobalt-chromium framework partial dentures</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>It's the gold standard biocompatible metal alloy used in thin sections, provide high strength and stiffness ,conduct heat and cold for a more natural experience, and is resistant to corrosion but their disadvantages include esthetic issues with metal display, oral galvanism, adverse tissue reactions,and osteolysis of abutment teeth.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PEEK framework partial dentures</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>It's a promising polymer-based framework has recently been introduced which is made of polyetheretherketone polymer frame combined with acrylic resin denture teeth and a conventional acrylic resin denture base.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>cobalt-chromium framework partial dentures</intervention_name>
    <description>It's a biocompatible metal alloy used in thin sections and are less bulky, provide high strength and stiffness ,conduct heat and cold for a more natural experience, enable designs that minimize the covering of the gingival margins, allow for a stable denture base, and is resistant to corrosion. Disadvantages include hypersensitivity, esthetic issues with metal display, oral galvanism, adverse tissue reactions, osteolysis of abutment teeth, and biofilm production .</description>
    <arm_group_label>cobalt-chromium framework partial dentures</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PEEK framework partial dentures</intervention_name>
    <description>It's a promising polymer-based framework material has recently been introduced which is made of polyetheretherketone polymer frame combined with acrylic resin denture teeth and a conventional acrylic resin denture base.</description>
    <arm_group_label>PEEK framework partial dentures</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Kennedy Class I partially edentulous subjects indicated for framework partial denture&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1- uncooperative patients . 2- bad oral hygiene patients .&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ahmed He Zidan, master</last_name>
    <phone>+201126534668</phone>
    <email>ahmedhefnyf@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Amr Ha Mohammed, master</last_name>
    <phone>+201001600625</phone>
    <email>amr_hatim@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Faculty of Oral and Dental Medicine Cairo University</name>
      <address>
        <city>Cairo</city>
        <zip>11311</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <contact>
      <last_name>Hassan Ahmed</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Abdel-Bary SK, Rostom EM, Elboarey AN. Thermoplastic Removable Partial Dentures versus Metal Cobalt-Chromium. RESEARCH JOURNAL OF PHARMACEUTICAL BIOLOGICAL AND CHEMICAL SCIENCES. 2016 Jul 1;7(4):464-70.</citation>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>December 13, 2018</last_update_submitted>
  <last_update_submitted_qc>December 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ahmed Hefny Zidan</investigator_full_name>
    <investigator_title>principle investigator</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cobalt</mesh_term>
    <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/NCT03777345
org study id: CEBD-CU-2018-11-28
nct id: NCT03777345
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study is aiming to evaluate the periodontal status of the abutment teeth in
      Polyetheretherketone ( PEEK ) framework partial dentures compared with cobalt-chromium ones
      in mandibular kennedy class I edentulous cases aiming to preserve the optimum periodontal
      health of the abutment teeth .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Periodontal status
time frame: Change in periodontal status will be assessed at base line , after one month and after 3 months .
description: periodontal status of the abutment teeth assessed by a periodontal chart .
arm group label: cobalt-chromium framework partial dentures
arm group type: Active Comparator
description: It's the gold standard biocompatible metal alloy used in thin sections, provide high strength and stiffness ,conduct heat and cold for a more natural experience, and is resistant to corrosion but their disadvantages include esthetic issues with metal display, oral galvanism, adverse tissue reactions,and osteolysis of abutment teeth.
arm group label: PEEK framework partial dentures
arm group type: Experimental
description: It's a promising polymer-based framework has recently been introduced which is made of polyetheretherketone polymer frame combined with acrylic resin denture teeth and a conventional acrylic resin denture base.
intervention type: Device
intervention name: cobalt-chromium framework partial dentures
description: It's a biocompatible metal alloy used in thin sections and are less bulky, provide high strength and stiffness ,conduct heat and cold for a more natural experience, enable designs that minimize the covering of the gingival margins, allow for a stable denture base, and is resistant to corrosion. Disadvantages include hypersensitivity, esthetic issues with metal display, oral galvanism, adverse tissue reactions, osteolysis of abutment teeth, and biofilm production .
arm group label: cobalt-chromium framework partial dentures
intervention type: Device
intervention name: PEEK framework partial dentures
description: It's a promising polymer-based framework material has recently been introduced which is made of polyetheretherketone polymer frame combined with acrylic resin denture teeth and a conventional acrylic resin denture base.
arm group label: PEEK framework partial dentures
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Ahmed He Zidan, master
phone: +201126534668
email: ahmedhefnyf@gmail.com
last name: Amr Ha Mohammed, master
phone: +201001600625
email: amr_hatim@yahoo.com
facility: 
contact: 
country: Egypt
citation: Abdel-Bary SK, Rostom EM, Elboarey AN. Thermoplastic Removable Partial Dentures versus Metal Cobalt-Chromium. RESEARCH JOURNAL OF PHARMACEUTICAL BIOLOGICAL AND CHEMICAL SCIENCES. 2016 Jul 1;7(4):464-70.
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ahmed Hefny Zidan
investigator title: principle investigator
mesh term: Cobalt
mesh term: Chromium
sharing ipd: Undecided