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/NCT06040385</url>
    </required_header>
    <id_info>
      <org_study_id>M0203023RP</org_study_id>
      <nct_id>NCT06040385</nct_id>
    </id_info>
    <brief_title>Effect of Geometric Modifications of Implant Scan Bodies</brief_title>
    <official_title>Effect of Geometric Modifications of Implant Scan Bodies Compared to Conventional Transfer Techniques on Passivity of Mandibular All on Four Restorations</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>
        The aim of this clinical study will be the effect of geometric modifications of implant scan&#xD;
        bodies compared to conventional transfer techniques on passivity of all on four mandibular&#xD;
        restorations&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The aim of this study will be the effect of geometric modifications of implant scan bodies&#xD;
        compared to conventional transfer techniques on passivity of all on four mandibular&#xD;
        restorations.&#xD;
  &#xD;
        Evaluation method:&#xD;
  &#xD;
        The trueness of the final impression and the passivity of the final prosthesis will be&#xD;
        evaluated by two methods:&#xD;
  &#xD;
        Invitro evaluation For each patient in every group, the standard tessellation language (STL)&#xD;
        files of scanned impressions will be superimposed on the reference file to determine the 3D&#xD;
        surface, linear, and angular position analysis.&#xD;
  &#xD;
        The STL files for both frameworks will be superimposed on the reference file to determine the&#xD;
        passivity.&#xD;
  &#xD;
        In vivo (Clinical) evaluation Radiographic evaluation using long cone parallel technique will&#xD;
        be done for the framework after 6 month (T6) after one year (T12), and after 18 month (T18)&#xD;
        from insertion.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">March 20, 2023</start_date>
    <completion_date type="Anticipated">December 16, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 7, 2023</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>
      <intervention_model_description>For group (I):&#xD;
  For each patient, two final impressions will be made a) Final impression will be done by conventional one-step impression technique.For the same patient, another final impression using unmodified scan bodies will be done by direct intraoral scan technique.&#xD;
  For group (II):&#xD;
  For each patient, two final impressions will be made&#xD;
  a) Final impression will be done by conventional one-step impression technique.For the same patient another final impression using subtractive modified scan bodies will be done by direct intraoral scan technique.&#xD;
  Conventional impression for both groups will be poured into stone cast with multiunit abutments analogues, then scanned to be as a reference file for each patient.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>passivity of the prosthesis</measure>
      <time_frame>one year</time_frame>
      <description>Radiographic evaluation using long cone parallel technique will be done for the framework</description>
    </primary_outcome>
    <primary_outcome>
      <measure>trueness of final impressions</measure>
      <time_frame>one year</time_frame>
      <description>For each patient in every group, the standard tessellation language (STL) files of scanned impressions will be superimposed on the reference file to determine the 3D surface, linear, and angular position analysis</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>patient satisfaction</measure>
      <time_frame>one year</time_frame>
      <description>patient satisfaction will be evaluated using Visual analogue scale questionnaire</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Prosthesis Durability</condition>
    <arm_group>
      <arm_group_label>• Group I (control group)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Final impression will be done by conventional one-step impression technique. For the same patient, another final impression using unmodified scan bodies will be done by direct intraoral scan technique.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>• Group II (Test Group)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Final impression will be done by conventional one-step impression technique. For the same patient another final impression using subtractive modified scan bodies will be done by direct intraoral scan technique</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Implant supported hybrid prosthesis</intervention_name>
      <description>For each patient, implant supported mandibular hybrid prosthesis will be fabricated digitally. Frameworks will be tried in patient's mouth, scanned intraorally by intraoral scanner (IOS).</description>
      <arm_group_label>• Group I (control group)</arm_group_label>
      <arm_group_label>• Group II (Test Group)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1. All selected patients will have four implants placed in the mandibular&#xD;
               interforaminal region according to all -on -four concept.&#xD;
  &#xD;
               2. All selected patients have a healthy mucosa and with no clinical complications.&#xD;
  &#xD;
               3. All patients are cooperative and approve the proposed treatment protocol.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  1. Patients who reject to participate in the study. 2. Patients who need implant&#xD;
               placement as a result of previous implant failure.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>45 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Mansoura University ,Faculty of dentistry</name>
        <address>
          <city>Mansoura</city>
          <zip>35516</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Prosthesis Failure</mesh_term>
    </condition_browse>
    <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/NCT06040385
  org study id: M0203023RP
  nct id: NCT06040385
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this clinical study will be the effect of geometric modifications of implant scan
        bodies compared to conventional transfer techniques on passivity of all on four mandibular
        restorations
  The aim of this study will be the effect of geometric modifications of implant scan bodies
        compared to conventional transfer techniques on passivity of all on four mandibular
        restorations.
  
        Evaluation method:
  
        The trueness of the final impression and the passivity of the final prosthesis will be
        evaluated by two methods:
  
        Invitro evaluation For each patient in every group, the standard tessellation language (STL)
        files of scanned impressions will be superimposed on the reference file to determine the 3D
        surface, linear, and angular position analysis.
  
        The STL files for both frameworks will be superimposed on the reference file to determine the
        passivity.
  
        In vivo (Clinical) evaluation Radiographic evaluation using long cone parallel technique will
        be done for the framework after 6 month (T6) after one year (T12), and after 18 month (T18)
        from insertion.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: For group (I):
  For each patient, two final impressions will be made a) Final impression will be done by conventional one-step impression technique.For the same patient, another final impression using unmodified scan bodies will be done by direct intraoral scan technique.
  For group (II):
  For each patient, two final impressions will be made
  a) Final impression will be done by conventional one-step impression technique.For the same patient another final impression using subtractive modified scan bodies will be done by direct intraoral scan technique.
  Conventional impression for both groups will be poured into stone cast with multiunit abutments analogues, then scanned to be as a reference file for each patient.
  primary purpose: Treatment
  masking: Single (Participant)
  measure: passivity of the prosthesis
  time frame: one year
  description: Radiographic evaluation using long cone parallel technique will be done for the framework
  measure: trueness of final impressions
  time frame: one year
  description: For each patient in every group, the standard tessellation language (STL) files of scanned impressions will be superimposed on the reference file to determine the 3D surface, linear, and angular position analysis
  measure: patient satisfaction
  time frame: one year
  description: patient satisfaction will be evaluated using Visual analogue scale questionnaire
  arm group label: • Group I (control group)
  arm group type: Active Comparator
  description: Final impression will be done by conventional one-step impression technique. For the same patient, another final impression using unmodified scan bodies will be done by direct intraoral scan technique.
  arm group label: • Group II (Test Group)
  arm group type: Active Comparator
  description: Final impression will be done by conventional one-step impression technique. For the same patient another final impression using subtractive modified scan bodies will be done by direct intraoral scan technique
  intervention type: Device
  intervention name: Implant supported hybrid prosthesis
  description: For each patient, implant supported mandibular hybrid prosthesis will be fabricated digitally. Frameworks will be tried in patient's mouth, scanned intraorally by intraoral scanner (IOS).
  arm group label: • Group I (control group)
  arm group label: • Group II (Test Group)
  criteria: 
  gender: All
  minimum age: 45 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Egypt
  responsible party type: Sponsor
  mesh term: Prosthesis Failure
  sharing ipd: No