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/NCT06012643</url>
    </required_header>
    <id_info>
      <org_study_id>A0107023RP</org_study_id>
      <nct_id>NCT06012643</nct_id>
    </id_info>
    <brief_title>Subperiosteal Implants. A Systematic Review of Case Reports and Case Series.</brief_title>
    <official_title>Subperiosteal Implants as a Treatment for Severely Atrophied Jaw in Completely and Partially Edentulous Population: A Systematic Review of Case Reports and Case Series.</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>
        Atrophied jaw is a condition where there is insufficient bone quantity to place root form&#xD;
        implants. Several treatment plans are available for treating atrophied jaws, including&#xD;
        subperiosteal implants. Subperiosteal implants were introduced in the last century. Poor&#xD;
        clinical results led those implants to be progressively abandoned. Recently, several Authors&#xD;
        suggested a revival of subperiosteal implants as an alternative to regenerative procedures.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        An electronic and manual search was conducted in the PubMed, Scopus, and Google Scholar&#xD;
        databases. Publications of case reports and series written in English without data&#xD;
        restrictions that reported on subperiosteal implants management of patients with severely&#xD;
        atrophied jaws in completely and partially edentulous population.&#xD;
  &#xD;
        The purpose of this systematic review of case reports and case series was to evaluate the&#xD;
        spectrum of subperiosteal implants for severely atrophied jaws using digital technology.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 1, 2023</start_date>
    <completion_date type="Anticipated">October 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 11, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>to evaluate the spectrum of subperiosteal implants for severely atrophied jaws using digital technology.</measure>
      <time_frame>5 year retrospective</time_frame>
      <description>The outcome was implant success or rejection.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Biological complications</measure>
      <time_frame>5 year retrospective</time_frame>
      <description>such as (dehiscence or exposure of the framework)</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Prosthetic complications</measure>
      <time_frame>5 year retrospective</time_frame>
      <description>such as (fracture of the definitive or temporary prosthesis)</description>
    </other_outcome>
    <enrollment type="Anticipated">23</enrollment>
    <condition>Alveolar Bone Loss</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>The purpose of this systematic review of case reports and case series was to evaluate the spectrum of subperiosteal implants for severely atrophied jaws using digital technology.</intervention_name>
      <description>An electronic and manual search was conducted in the PubMed, Scopus, and Google Scholar databases. Publications of case reports and series written in English without data restrictions</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          An electronic and manual search was conducted in the PubMed, Scopus, and Google Scholar&#xD;
          databases. Publications of case reports and series written in English without data&#xD;
          restrictions in the last 5 years.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  population with partial or fully edentulous arches, in particular Cawood and Howell&#xD;
               class (IV-VI);&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Articles were excluded if complex reconstructive surgery including bone grafts,&#xD;
               barrier membranes, jaw osteotomies, sinus lift, alveolar ridge distraction, and&#xD;
               zygomatic implants was recommended for treatment&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>15 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Mohammed ELSawy, PhD</last_name>
      <phone>00201061314522</phone>
      <email>Dr_sawy@windowslive.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Salah A. Hegazy, PhD</last_name>
      <phone>00201227690209</phone>
      <email>salahhegazy@yahoo.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Mohammed El Sawy</name>
        <address>
          <city>Multiple Locations</city>
          <zip>12345</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mohammed E Sawy, PhD</last_name>
        <phone>+201061314522</phone>
        <email>Dr_sawy@windowslive.com</email>
      </contact>
      <contact_backup>
        <last_name>Salah A. Hegazy, PhD</last_name>
        <phone>+01227690809</phone>
        <email>salahhegazy2003@yahoo.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 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>Alveolar Bone Loss</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>just by contacting the corresponding author</ipd_description>
    </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/NCT06012643
  org study id: A0107023RP
  nct id: NCT06012643
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Atrophied jaw is a condition where there is insufficient bone quantity to place root form
        implants. Several treatment plans are available for treating atrophied jaws, including
        subperiosteal implants. Subperiosteal implants were introduced in the last century. Poor
        clinical results led those implants to be progressively abandoned. Recently, several Authors
        suggested a revival of subperiosteal implants as an alternative to regenerative procedures.
  An electronic and manual search was conducted in the PubMed, Scopus, and Google Scholar
        databases. Publications of case reports and series written in English without data
        restrictions that reported on subperiosteal implants management of patients with severely
        atrophied jaws in completely and partially edentulous population.
  
        The purpose of this systematic review of case reports and case series was to evaluate the
        spectrum of subperiosteal implants for severely atrophied jaws using digital technology.
  observational model: Other
  time perspective: Retrospective
  measure: to evaluate the spectrum of subperiosteal implants for severely atrophied jaws using digital technology.
  time frame: 5 year retrospective
  description: The outcome was implant success or rejection.
  measure: Biological complications
  time frame: 5 year retrospective
  description: such as (dehiscence or exposure of the framework)
  measure: Prosthetic complications
  time frame: 5 year retrospective
  description: such as (fracture of the definitive or temporary prosthesis)
  intervention type: Other
  intervention name: The purpose of this systematic review of case reports and case series was to evaluate the spectrum of subperiosteal implants for severely atrophied jaws using digital technology.
  description: An electronic and manual search was conducted in the PubMed, Scopus, and Google Scholar databases. Publications of case reports and series written in English without data restrictions
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 15 Years
  maximum age: 85 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Mohammed ELSawy, PhD
  phone: 00201061314522
  email: Dr_sawy@windowslive.com
  last name: Salah A. Hegazy, PhD
  phone: 00201227690209
  email: salahhegazy@yahoo.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Egypt
  responsible party type: Sponsor
  mesh term: Alveolar Bone Loss
  sharing ipd: No
  ipd description: just by contacting the corresponding author