<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/NCT03771248</url>
  </required_header>
  <id_info>
    <org_study_id>Prosthesis1234</org_study_id>
    <nct_id>NCT03771248</nct_id>
  </id_info>
  <brief_title>Polyetheretherketone vs Cobalt-chromium Telescopic Removable Partial Denture in Kennedy Class I Patients Regarding Oral Health Related Quality of Life</brief_title>
  <official_title>A Comparison Between Polyetheretherketone and Cobalt-chromium Telescopic Removable Partial Denture in Kennedy Class I Partially Edentulous Patients Regarding Oral Health Related Quality of Life (A Randomized Clinical Trial)</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>
      Dentistry is a rapidly progressing field with innumerable advances taking place on a day to&#xD;
      day basis. The application of newer technologies and materials has advanced the specialty of&#xD;
      prosthodontics and the services rendered to the patients.&#xD;
&#xD;
      Taking into consideration that PEEK as a material wasn't clinically investigated to be used&#xD;
      as a material for routine use, however PEEK in removable partial dentures will help in making&#xD;
      many steps easier and reach patients demands regarding esthetics. Also, owing to the superior&#xD;
      mechanical and biological properties of PEEK, it will not be surprising if dentures&#xD;
      constructed from the polymer are routinely constructed in near future.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      On fabrication of telescopic removable partial denture, choosing the material is a major step&#xD;
      in the success of the treatment. There are different aspects that should be taken into&#xD;
      consideration while choosing it. Beginning with retention as it is a crucial aspect. The&#xD;
      retention of the telescopic partial denture is gained from the friction between the primary&#xD;
      and secondary crowns. The chosen material should be able to maintain this type of retention&#xD;
      for the longest possible period.&#xD;
&#xD;
      The esthetics also affects the treatment choice and patients preference, patients would&#xD;
      choose metal free restorations over the ones that display metal. Finally the load&#xD;
      distribution between the residual ridge and abutment should be equalized and transmitted in a&#xD;
      favorable way. Otherwise one of the following consequences will occur; either overload on the&#xD;
      abutment teeth followed by bone loss and abutment mobility or this overload is on the&#xD;
      residual ridge leading to fast, progressive bone loss.&#xD;
&#xD;
      Cobalt chromium that is used for fabricating the telescopic removable partial denture is&#xD;
      considered that most suitable material up till this moment. However, it doesn't fulfill much&#xD;
      of the previous points.&#xD;
&#xD;
      As there will always be a continued improvement of materials and techniques used in dentistry&#xD;
      especially in prosthodontics, innovative techniques must be regarded as potential&#xD;
      alternatives to traditional materials.&#xD;
&#xD;
      PEEK is from the innovative materials that has shown promising results in different branches.&#xD;
      However, to date no clinical studies or systematic reviews focusing on the use of PEEK&#xD;
      dentures have been published, therefore more investigations are needed in this field.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 2019</start_date>
  <completion_date type="Anticipated">July 2020</completion_date>
  <primary_completion_date type="Anticipated">January 2020</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>oral health impact profile</measure>
    <time_frame>12 months</time_frame>
    <description>questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>probing depth of abutment teeth</measure>
    <time_frame>12 months</time_frame>
    <description>using williams graduated probe</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>abutment mobility</measure>
    <time_frame>12 months</time_frame>
    <description>millers classification</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Partially Edentulous Mandible</condition>
  <arm_group>
    <arm_group_label>Co-cr telescopic partial denture</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A removable partial denture, that gains retention from a telescopic crown made of cobalt chromium</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PEEK telescopic partial denture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A removable partial denture, its attachment is a telescopic crown made of PEEK</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>peek telescopic partial denture</intervention_name>
    <description>removable partial denture</description>
    <arm_group_label>Co-cr telescopic partial denture</arm_group_label>
    <arm_group_label>PEEK telescopic partial denture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  - Kennedy Class I Partially edentulous patients.&#xD;
&#xD;
          -  Patients with good oral hygiene.&#xD;
&#xD;
          -  The distal abutment bilaterally should be a premolar.&#xD;
&#xD;
          -  Abutment teeth should be in a good periodontal condition.&#xD;
&#xD;
          -  Sufficient inter-arch space, any super-eruptions should be treated before beginning of&#xD;
             treatment.&#xD;
&#xD;
          -  There should be no modifications spaces in the arch to be treated, and if found it&#xD;
             should be treated with a fixed partial denture first.&#xD;
&#xD;
          -  Normal tongue size&#xD;
&#xD;
          -  Medically free from any disease that might affect bone support&#xD;
&#xD;
          -  Patients with no history of bad oral habits as (Bruxism or Clenching) and free from&#xD;
             any T.M.J disorders.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with bad oral hygiene.&#xD;
&#xD;
          -  Teeth with severe malalignment.&#xD;
&#xD;
          -  The arch to be treated is opposed by a completely edentulous arch.&#xD;
&#xD;
          -  Unmotivated patient.&#xD;
&#xD;
          -  Patient with a medical disease that will hinder his ability to be committed to the&#xD;
             treatment.&#xD;
&#xD;
          -  Patients on a radiation therapy.&#xD;
&#xD;
          -  Patients with xerostomia.&#xD;
&#xD;
          -  Patients with a history of drug, alcohol abuse or psychiatric disorder.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>December 10, 2018</last_update_submitted>
  <last_update_submitted_qc>December 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>tasneem gamal youssef el mashad</investigator_full_name>
    <investigator_title>assistant lecturer</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mouth, Edentulous</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/NCT03771248
org study id: Prosthesis1234
nct id: NCT03771248
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Dentistry is a rapidly progressing field with innumerable advances taking place on a day to
      day basis. The application of newer technologies and materials has advanced the specialty of
      prosthodontics and the services rendered to the patients.

      Taking into consideration that PEEK as a material wasn't clinically investigated to be used
      as a material for routine use, however PEEK in removable partial dentures will help in making
      many steps easier and reach patients demands regarding esthetics. Also, owing to the superior
      mechanical and biological properties of PEEK, it will not be surprising if dentures
      constructed from the polymer are routinely constructed in near future.
On fabrication of telescopic removable partial denture, choosing the material is a major step
      in the success of the treatment. There are different aspects that should be taken into
      consideration while choosing it. Beginning with retention as it is a crucial aspect. The
      retention of the telescopic partial denture is gained from the friction between the primary
      and secondary crowns. The chosen material should be able to maintain this type of retention
      for the longest possible period.

      The esthetics also affects the treatment choice and patients preference, patients would
      choose metal free restorations over the ones that display metal. Finally the load
      distribution between the residual ridge and abutment should be equalized and transmitted in a
      favorable way. Otherwise one of the following consequences will occur; either overload on the
      abutment teeth followed by bone loss and abutment mobility or this overload is on the
      residual ridge leading to fast, progressive bone loss.

      Cobalt chromium that is used for fabricating the telescopic removable partial denture is
      considered that most suitable material up till this moment. However, it doesn't fulfill much
      of the previous points.

      As there will always be a continued improvement of materials and techniques used in dentistry
      especially in prosthodontics, innovative techniques must be regarded as potential
      alternatives to traditional materials.

      PEEK is from the innovative materials that has shown promising results in different branches.
      However, to date no clinical studies or systematic reviews focusing on the use of PEEK
      dentures have been published, therefore more investigations are needed in this field.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: oral health impact profile
time frame: 12 months
description: questionnaire
measure: probing depth of abutment teeth
time frame: 12 months
description: using williams graduated probe
measure: abutment mobility
time frame: 12 months
description: millers classification
arm group label: Co-cr telescopic partial denture
arm group type: Active Comparator
description: A removable partial denture, that gains retention from a telescopic crown made of cobalt chromium
arm group label: PEEK telescopic partial denture
arm group type: Experimental
description: A removable partial denture, its attachment is a telescopic crown made of PEEK
intervention type: Device
intervention name: peek telescopic partial denture
description: removable partial denture
arm group label: Co-cr telescopic partial denture
arm group label: PEEK telescopic partial denture
criteria: 
gender: All
minimum age: N/A
maximum age: 70 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: tasneem gamal youssef el mashad
investigator title: assistant lecturer
mesh term: Mouth, Edentulous