<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/NCT03777280</url>
  </required_header>
  <id_info>
    <org_study_id>CEBD-CU-2018-11-27</org_study_id>
    <nct_id>NCT03777280</nct_id>
  </id_info>
  <brief_title>Comparison Between Injection Molded PEEK Framework and Cobalt Chromium Framework in Removable Partial Denture Regarding Retention</brief_title>
  <official_title>Evaluation of Retention of Partial Denture 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 retentive forces in PEEK framework RPD compared to&#xD;
      Cobalt-Chrome framework RPD during attachment/detachment cycles in mandibular kennedy class I&#xD;
      edentulous cases&#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>Retention</measure>
    <time_frame>change from baseline retention force after one month and after three months</time_frame>
    <description>retention force of RPD during attachment/detachment cycles measured by digital force meter device</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>peek framework Removable partial denture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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>
  <arm_group>
    <arm_group_label>cobalt chromium framework Removable partial denture</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>it's the gold standard framework which has many benefits such as they are used in thin sections and are less bulky,provide high strength and stiffness,and some disadvantages include hypersensitivity,metal display and oral galvanism,</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>peek framework RPD</intervention_name>
    <description>it is a polyetheretherketone polymer frame combined with acrylic resin denture teeth and a conventional acrylic resin denture base made by injecting technique and have several advantages regarding strength and esthetics</description>
    <arm_group_label>peek framework Removable partial denture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>cobalt chromium framework RPD</intervention_name>
    <description>standard framework device</description>
    <arm_group_label>cobalt chromium framework Removable partial denture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  . kennedy class I edentulous subjects indicated for framework partial denture&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncooperative patients and 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>haytham mo talaat, master</last_name>
    <phone>+201210520141</phone>
    <email>haythamtalaat.zb@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>ahmed hefny zidan, master</last_name>
    <phone>+201126534668</phone>
    <email>ahmedhefnyf@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Faculty of Oral and Dental Medicine Cairo University</name>
      <address>
        <city>Cairo</city>
        <state>Manial</state>
        <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>Souza JE, Silva NR, Coelho PG, Zavanelli AC, Ferracioli RC, Zavanelli RA. Retention strength of cobalt-chromium vs nickel-chromium titanium vs CP titanium in a cast framework association of removable partial overdenture. J Contemp Dent Pract. 2011 May 1;12(3):179-86. doi: 10.5005/jp-journals-10024-1031.</citation>
    <PMID>22186813</PMID>
  </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>Haytham Mohammed talaat ahmed</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/NCT03777280
org study id: CEBD-CU-2018-11-27
nct id: NCT03777280
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study is aiming to evaluate the retentive forces in PEEK framework RPD compared to
      Cobalt-Chrome framework RPD during attachment/detachment cycles in mandibular kennedy class I
      edentulous cases
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Retention
time frame: change from baseline retention force after one month and after three months
description: retention force of RPD during attachment/detachment cycles measured by digital force meter device
arm group label: peek framework Removable partial denture
arm group type: Experimental
description: 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.
arm group label: cobalt chromium framework Removable partial denture
arm group type: Active Comparator
description: it's the gold standard framework which has many benefits such as they are used in thin sections and are less bulky,provide high strength and stiffness,and some disadvantages include hypersensitivity,metal display and oral galvanism,
intervention type: Device
intervention name: peek framework RPD
description: it is a polyetheretherketone polymer frame combined with acrylic resin denture teeth and a conventional acrylic resin denture base made by injecting technique and have several advantages regarding strength and esthetics
arm group label: peek framework Removable partial denture
intervention type: Device
intervention name: cobalt chromium framework RPD
description: standard framework device
arm group label: cobalt chromium framework Removable partial denture
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: haytham mo talaat, master
phone: +201210520141
email: haythamtalaat.zb@gmail.com
last name: ahmed hefny zidan, master
phone: +201126534668
email: ahmedhefnyf@gmail.com
facility: 
contact: 
country: Egypt
citation: Souza JE, Silva NR, Coelho PG, Zavanelli AC, Ferracioli RC, Zavanelli RA. Retention strength of cobalt-chromium vs nickel-chromium titanium vs CP titanium in a cast framework association of removable partial overdenture. J Contemp Dent Pract. 2011 May 1;12(3):179-86. doi: 10.5005/jp-journals-10024-1031.
PMID: 22186813
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Haytham Mohammed talaat ahmed
investigator title: principle investigator
mesh term: Cobalt
mesh term: Chromium
sharing ipd: Undecided