<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/NCT03777423</url>
  </required_header>
  <id_info>
    <org_study_id>CEBD-CU-2018-11-29</org_study_id>
    <nct_id>NCT03777423</nct_id>
  </id_info>
  <brief_title>Comparison Between Injection Molded PEEK Framework and Cobalt Chromium Framework Removable Partial Dentures Regarding Biting Force</brief_title>
  <official_title>Evaluation of Biting Force of Removable 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 biting force of polyetheretherketone (PEEK) framework&#xD;
      partial dentures compared to that of cobalt-chromium ones in mandibular Kennedy class I&#xD;
      edentulous cases hoping that polyetheretherketone (PEEK) framework removable partial dentures&#xD;
      can improve the patient masticatory efficiency .&#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>Biting force</measure>
    <time_frame>Change in baseline biting force from time of insertion, insertion after 1 month and after 3 months</time_frame>
    <description>Biting force of the patient wearing the removable partial denture measured by I-load sensor 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 partial dentures</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High performance ketone polymers introduced lately.These polymer-based frameworks provide better esthetics, higher elasticity, lighter in weight, have low water sorption and solubility, and are easily repaired and reproduced.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cobalt-chromium framework partial dentures</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>it is considered the gold standard framework. These frameworks are less bulky with high strength, conduct heat and electricity well, and have good durability. some disadvantages include hypersensitivity, adverse tissue reactions and bad aesthetics.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PEEK framework partial dentures</intervention_name>
    <description>Polymer-based framework recently introduced 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>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cobalt- chromium framework partial dentures</intervention_name>
    <description>It's a bio-compatible metal used in thin sections so 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 resistance to corrosion.Drawbacks of metal frameworks can include hypersensitivity, aesthetics because of metal 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>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -Kennedy class 1 partially edentulous subjects indicated for framework partial denture&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncooperative patients&#xD;
&#xD;
          -  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>Amr Ha Mohammed, Master</last_name>
    <phone>+201001600625</phone>
    <email>amr_hatim@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>haytham Mo Talaat, master</last_name>
    <phone>+201210520141</phone>
    <email>haythamtalaat.zb@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Faculty of oral and dental medincine 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>
  <results_reference>
    <citation>Al-Jammali ZM. Clinical Evaluation of Maximum Bite Force in Patient with Heat Cure acrylic and Flexible Partial Dentures. Medical Journal of Babylon. 2017;14(3):509-17.</citation>
  </results_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>Amr Hatim Mohammed</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/NCT03777423
org study id: CEBD-CU-2018-11-29
nct id: NCT03777423
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study is aiming to evaluate the biting force of polyetheretherketone (PEEK) framework
      partial dentures compared to that of cobalt-chromium ones in mandibular Kennedy class I
      edentulous cases hoping that polyetheretherketone (PEEK) framework removable partial dentures
      can improve the patient masticatory efficiency .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Biting force
time frame: Change in baseline biting force from time of insertion, insertion after 1 month and after 3 months
description: Biting force of the patient wearing the removable partial denture measured by I-load sensor device.
arm group label: PEEK framework partial dentures
arm group type: Experimental
description: High performance ketone polymers introduced lately.These polymer-based frameworks provide better esthetics, higher elasticity, lighter in weight, have low water sorption and solubility, and are easily repaired and reproduced.
arm group label: Cobalt-chromium framework partial dentures
arm group type: Active Comparator
description: it is considered the gold standard framework. These frameworks are less bulky with high strength, conduct heat and electricity well, and have good durability. some disadvantages include hypersensitivity, adverse tissue reactions and bad aesthetics.
intervention type: Device
intervention name: PEEK framework partial dentures
description: Polymer-based framework recently introduced 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
intervention type: Device
intervention name: Cobalt- chromium framework partial dentures
description: It's a bio-compatible metal used in thin sections so 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 resistance to corrosion.Drawbacks of metal frameworks can include hypersensitivity, aesthetics because of metal metal display, oral galvanism, adverse tissue reactions, osteolysis of abutment teeth, and biofilm production
arm group label: Cobalt-chromium framework partial dentures
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Amr Ha Mohammed, Master
phone: +201001600625
email: amr_hatim@yahoo.com
last name: haytham Mo Talaat, master
phone: +201210520141
email: haythamtalaat.zb@gmail.com
facility: 
contact: 
country: Egypt
citation: Al-Jammali ZM. Clinical Evaluation of Maximum Bite Force in Patient with Heat Cure acrylic and Flexible Partial Dentures. Medical Journal of Babylon. 2017;14(3):509-17.
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Amr Hatim Mohammed
investigator title: Principle investigator
mesh term: Cobalt
mesh term: Chromium
sharing ipd: Undecided