xml: <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/NCT06017596</url>
    </required_header>
    <id_info>
      <org_study_id>A17100221</org_study_id>
      <nct_id>NCT06017596</nct_id>
    </id_info>
    <brief_title>CAD-CAM PEEK Framework for All-on-4 Implants</brief_title>
    <official_title>Evaluation of Polyetheretherketone (PEEK) Framework Inserted in Multiunit Abutments of All-on-4 Concept for the Mandibular Edentulous Arch.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mansoura University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mansoura 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 was conducted to evaluate the clinical peri-implant soft tissue changes during the&#xD;
        first year after occlusal loading and the ridge base relation after 3 years for mandibular&#xD;
        computer-aided design and computer-aided manufacturing (CAD/CAM) screw-retained&#xD;
        implant-supported hybrid prosthesis of polyetheretherketone (PEEK) framework utilized with&#xD;
        All-on-Four treatment concept.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Sixteen completely edentulous patients were rehabilitated by four implants following the&#xD;
        All-on-Four protocol. After 3 months, the definitive prosthesis was constructed to be a&#xD;
        screw-retained CAD-CAM milled framework from the modified PEEK (BioHPP), bonded to&#xD;
        polymethylmethacrylate teeth and a pink-shaded indirect light-polymerized nano-filled&#xD;
        composite resin imitating the soft tissues. Peri-implant soft tissue changes regarding&#xD;
        plaque, bleeding, gingival scores, and probing depth were evaluated at prosthesis insertion&#xD;
        (T0), 6 months (T1), and 12 months (T2) after insertion. Also, monitoring of the ridge base&#xD;
        relation was performed using cone-beam computed tomography CBCT at the time of insertion&#xD;
        (T0), and 1 year (T1), 2 years (T2), and 3 years (T3) after mandibular fixed detachable&#xD;
        All-on-Four framework insertion.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 23, 2021</start_date>
    <completion_date type="Actual">March 20, 2023</completion_date>
    <primary_completion_date type="Actual">February 12, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>evaluation of changes in the peri-implant soft tissue health</measure>
      <time_frame>six months</time_frame>
      <description>Peri-implant soft tissue changes regarding plaque scores were assessed using the modified plaque index</description>
    </primary_outcome>
    <primary_outcome>
      <measure>evaluation of changes in the peri-implant soft tissue health</measure>
      <time_frame>six months</time_frame>
      <description>Peri-implant soft tissue changes regarding bleeding scores were assessed using the bleeding index.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>evaluation of changes in the peri-implant soft tissue health</measure>
      <time_frame>six months</time_frame>
      <description>Peri-implant soft tissue changes regarding the gingival scores were assessed using the simplified gingival index.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Ridge base relation monitoring</measure>
      <time_frame>3 years</time_frame>
      <description>periodic monitoring of the changes in the alveolar ridge height in millimeters using CBCT</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">16</enrollment>
    <condition>Bone Loss</condition>
    <arm_group>
      <arm_group_label>PEEK group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients received PEEK framework prosthesis</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>PEEK framework</intervention_name>
      <description>All-on-4 implants with PEEK framework of fixed detachable prosthesis</description>
      <arm_group_label>PEEK group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Completely edentulous maxillary and mandibular ridges with sufficient mandibular bone&#xD;
               height in the inter-foraminal area confirmed with panoramic x-rays.&#xD;
  &#xD;
            -  All selected patients will be with sufficient inter-arch space and restorative space.&#xD;
  &#xD;
            -  All selected patients will have apparently healthy ridge covered by compressible oral&#xD;
               mucosa and free from any ridge flabbiness.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with systemic diseases that contraindicate implant placement such as&#xD;
               hematologic diseases, serious problems of coagulation and diseases of the immune&#xD;
               system. Also, metabolic diseases related to bone resorption such as uncontrolled&#xD;
               diabetics or osteoporosis will be also excluded&#xD;
  &#xD;
            -  History of para-functional habits (Bruxism, clenching), smoking and alcoholism.&#xD;
  &#xD;
            -  History of radiation therapy in the head and neck region.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Khloud Ezzat, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Lecturer of Prosthodontics</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Khloud Ezzat</name>
        <address>
          <city>Mansoura</city>
          <zip>54790</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 5, 2023</study_first_submitted>
    <study_first_submitted_qc>August 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 27, 2023</last_update_submitted>
    <last_update_submitted_qc>August 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>All-on-Four implant</keyword>
    <keyword>CAD-CAM</keyword>
    <keyword>PEEK framework</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06017596
  org study id: A17100221
  nct id: NCT06017596
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study was conducted to evaluate the clinical peri-implant soft tissue changes during the
        first year after occlusal loading and the ridge base relation after 3 years for mandibular
        computer-aided design and computer-aided manufacturing (CAD/CAM) screw-retained
        implant-supported hybrid prosthesis of polyetheretherketone (PEEK) framework utilized with
        All-on-Four treatment concept.
  Sixteen completely edentulous patients were rehabilitated by four implants following the
        All-on-Four protocol. After 3 months, the definitive prosthesis was constructed to be a
        screw-retained CAD-CAM milled framework from the modified PEEK (BioHPP), bonded to
        polymethylmethacrylate teeth and a pink-shaded indirect light-polymerized nano-filled
        composite resin imitating the soft tissues. Peri-implant soft tissue changes regarding
        plaque, bleeding, gingival scores, and probing depth were evaluated at prosthesis insertion
        (T0), 6 months (T1), and 12 months (T2) after insertion. Also, monitoring of the ridge base
        relation was performed using cone-beam computed tomography CBCT at the time of insertion
        (T0), and 1 year (T1), 2 years (T2), and 3 years (T3) after mandibular fixed detachable
        All-on-Four framework insertion.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: evaluation of changes in the peri-implant soft tissue health
  time frame: six months
  description: Peri-implant soft tissue changes regarding plaque scores were assessed using the modified plaque index
  measure: evaluation of changes in the peri-implant soft tissue health
  time frame: six months
  description: Peri-implant soft tissue changes regarding bleeding scores were assessed using the bleeding index.
  measure: evaluation of changes in the peri-implant soft tissue health
  time frame: six months
  description: Peri-implant soft tissue changes regarding the gingival scores were assessed using the simplified gingival index.
  measure: Ridge base relation monitoring
  time frame: 3 years
  description: periodic monitoring of the changes in the alveolar ridge height in millimeters using CBCT
  arm group label: PEEK group
  arm group type: Experimental
  description: Patients received PEEK framework prosthesis
  intervention type: Device
  intervention name: PEEK framework
  description: All-on-4 implants with PEEK framework of fixed detachable prosthesis
  arm group label: PEEK group
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Khloud Ezzat, PhD
  role: Principal Investigator
  affiliation: Lecturer of Prosthodontics
  facility: 
  country: Egypt
  responsible party type: Sponsor
  sharing ipd: No