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/NCT06031506</url>
    </required_header>
    <id_info>
      <org_study_id>M03071221</org_study_id>
      <nct_id>NCT06031506</nct_id>
    </id_info>
    <brief_title>Management of Severely Atrophied Maxillary Ridge Using Quad Zygomatic Implants</brief_title>
    <official_title>Management of Severely Atrophied Maxillary Ridge Using Quad Zygomatic Implants to Support Immediately Loaded Hybrid Prosthesis.One Year Evaluation of Occlusal Contact and Ridge Resorption</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 clinical study will aim to compare and evaluate zygomatic implant stability, occlusal&#xD;
        contact, and bone level changes around dental implants&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The aim of this study will be to compare and evaluate zygomatic implant stability, occlusal&#xD;
        contact, and bone level changes around dental implants and that of the atrophied maxilla&#xD;
        rehabilitated with immediate loaded hyprid prosthesis supported by 4 zygomatic implants.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">December 15, 2022</start_date>
    <completion_date type="Anticipated">June 16, 2024</completion_date>
    <primary_completion_date type="Actual">March 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>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>All patients will receive conventional maxillary and mandibular complete dentures The implant size will be selected for each area according to the available bone length and width as measured by CBCT radiograph.&#xD;
  All implants will be surgically installed guided by steriolethognathic stents&#xD;
  - Multi-unit abutments will be connected to implants and will be immedietly loaded by fixed full arch screw retained provisional acrylic restoration.&#xD;
  Final prosthesis will be delivered 6-8 months later</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>patient satisfaction</measure>
      <time_frame>one year</time_frame>
      <description>The patient satisfaction will be evaluated using the visual analog scale (VAS) questionnaire at base line, 6, and 12 months later</description>
    </primary_outcome>
    <primary_outcome>
      <measure>marginal implant bone loss</measure>
      <time_frame>one year</time_frame>
      <description>The implant marginal bone height changes will be measured radiographically at base line, 6, and 12 months later</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>posterior area index</measure>
      <time_frame>one year</time_frame>
      <description>the area index of the anterior and posterior maxillary ridge will be measured radiographically at base line, 6, and 12 months later</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">15</enrollment>
    <condition>Prosthesis Durability</condition>
    <arm_group>
      <arm_group_label>quad zygomatic hybrid maxillary prosthesis</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>All patients will be rehabilitated with immediate loaded hybrid prosthesis supported by 4 zygomatic implants.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Implant supported hybrid maxillary prosthesis</intervention_name>
      <description>All patients will receive immediately loaded hybrid prosthesis supported by 4 zygomatic implants.</description>
      <arm_group_label>quad zygomatic hybrid maxillary prosthesis</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All patients will have healthy healed residual alveolar ridges, Angle's class I&#xD;
               maxillomandibular relations, available maxillary restorative space. This will be&#xD;
               verified by tentative jaw relation records.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  All detrimental bad habits like smoking, TMJ clicking or TMJ dysfunction will be&#xD;
               excluded.&#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>P.O.Box: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 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 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/NCT06031506
  org study id: M03071221
  nct id: NCT06031506
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This clinical study will aim to compare and evaluate zygomatic implant stability, occlusal
        contact, and bone level changes around dental implants
  The aim of this study will be to compare and evaluate zygomatic implant stability, occlusal
        contact, and bone level changes around dental implants and that of the atrophied maxilla
        rehabilitated with immediate loaded hyprid prosthesis supported by 4 zygomatic implants.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: All patients will receive conventional maxillary and mandibular complete dentures The implant size will be selected for each area according to the available bone length and width as measured by CBCT radiograph.
  All implants will be surgically installed guided by steriolethognathic stents
  - Multi-unit abutments will be connected to implants and will be immedietly loaded by fixed full arch screw retained provisional acrylic restoration.
  Final prosthesis will be delivered 6-8 months later
  primary purpose: Treatment
  masking: None (Open Label)
  measure: patient satisfaction
  time frame: one year
  description: The patient satisfaction will be evaluated using the visual analog scale (VAS) questionnaire at base line, 6, and 12 months later
  measure: marginal implant bone loss
  time frame: one year
  description: The implant marginal bone height changes will be measured radiographically at base line, 6, and 12 months later
  measure: posterior area index
  time frame: one year
  description: the area index of the anterior and posterior maxillary ridge will be measured radiographically at base line, 6, and 12 months later
  arm group label: quad zygomatic hybrid maxillary prosthesis
  arm group type: Experimental
  description: All patients will be rehabilitated with immediate loaded hybrid prosthesis supported by 4 zygomatic implants.
  intervention type: Device
  intervention name: Implant supported hybrid maxillary prosthesis
  description: All patients will receive immediately loaded hybrid prosthesis supported by 4 zygomatic implants.
  arm group label: quad zygomatic hybrid maxillary prosthesis
  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