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/NCT05972447</url>
    </required_header>
    <id_info>
      <org_study_id>0210-01/2021</org_study_id>
      <nct_id>NCT05972447</nct_id>
    </id_info>
    <brief_title>Ultra-wide Diameter Implants in Mandibular Molars</brief_title>
    <acronym>UWD</acronym>
    <official_title>Evaluation of Immediately Placed Ultra-wide Diameter Implant Placed in Mandibular Molars</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Abdelrahman Elshahawy</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Alexandria University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this [clinical trial] is to [To evaluate both the clinical and radiographical&#xD;
        outcome on osteointegration and peri-implant bone density when using ultra wide diameter&#xD;
        implant placed immediately in molar extraction socket]&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        the aim of this study is to evaluate the clinical and radiographical outcomes on&#xD;
        osseointegration and peri-implant bone density when using 12 ultrawide diameter dental&#xD;
        implants placed immediately in 12 patients after atraumatic extraction of non-restorable&#xD;
        mandibular molars without raising a flap or using bone grafts.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">May 20, 2021</start_date>
    <completion_date type="Actual">March 3, 2022</completion_date>
    <primary_completion_date type="Actual">January 12, 2022</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>the mean value of implant stability</measure>
      <time_frame>up to 6months</time_frame>
      <description>The implant stability was measured by implant stability meter (Osstell™) immediately postoperative and at 6 months.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>the mean value of peri-implant bone density</measure>
      <time_frame>up to 9 months</time_frame>
      <description>Radiographic evaluation of the bone density around each implant was done using OnDemand3D™.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>the mean value of Marginal bone loss</measure>
      <time_frame>up to 9months</time_frame>
      <description>marginal bone levels were calculated from the reconstructed corrected sagittal views by drawing a line parallel to the implant serration extending from the crestal bone to the apical end of the implant. Average readings of the two sides at each interval were calculated and tabulated for statistical analysis.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>the mean of peri-implant probing depth</measure>
      <time_frame>up to 9 months</time_frame>
      <description>Probing depth was assessed according to Gallagher and Silver Probing pocket depth refers to the distance between the gingival margin and the bottom of the pocket</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">12</enrollment>
    <condition>Dental Implants</condition>
    <arm_group>
      <arm_group_label>non-restorable mandibular molar teeth</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>patients with non restorable mandibular molar teeth without any periapical pathosis to be extracted and implanted immediately using ultrawide diameter dental implants</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Immediate implant placement of Ultrawide diameter dental implants</intervention_name>
      <description>immediate placement of ultrawide diameter dental implants in a fresh extraction socket of mandibular molar teeth</description>
      <arm_group_label>non-restorable mandibular molar teeth</arm_group_label>
      <other_name>Ultrawide diameter dental implants</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Adult patients ranging from 20-40 years.&#xD;
  &#xD;
            -  Adequate bone beyond teeth apices without jeopardizing any anatomical structure.&#xD;
  &#xD;
            -  Non-restorable mandibular molar teeth.&#xD;
  &#xD;
            -  Available bone with adequate width and buccolingual dimensions.&#xD;
  &#xD;
            -  Peri-implant bone defect should be 2mm or lesser.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Smokers.&#xD;
  &#xD;
            -  Medically compromised patients like uncontrolled diabetes and coagulation disorders.&#xD;
  &#xD;
            -  Tooth with periapical pathosis or bony defects.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Gaafar N Elhalawani</last_name>
      <role>Study Director</role>
      <affiliation>Alexandria University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Alexandria University</name>
        <address>
          <city>Alexandria</city>
          <zip>20200</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Alexandria University</investigator_affiliation>
      <investigator_full_name>Abdelrahman Elshahawy</investigator_full_name>
      <investigator_title>principle investigator</investigator_title>
    </responsible_party>
    <keyword>UWD implants</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol and Statistical Analysis Plan</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>March 7, 2021</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/47/NCT05972447/Prot_SAP_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT05972447
  org study id: 0210-01/2021
  nct id: NCT05972447
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this [clinical trial] is to [To evaluate both the clinical and radiographical
        outcome on osteointegration and peri-implant bone density when using ultra wide diameter
        implant placed immediately in molar extraction socket]
  the aim of this study is to evaluate the clinical and radiographical outcomes on
        osseointegration and peri-implant bone density when using 12 ultrawide diameter dental
        implants placed immediately in 12 patients after atraumatic extraction of non-restorable
        mandibular molars without raising a flap or using bone grafts.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: the mean value of implant stability
  time frame: up to 6months
  description: The implant stability was measured by implant stability meter (Osstell™) immediately postoperative and at 6 months.
  measure: the mean value of peri-implant bone density
  time frame: up to 9 months
  description: Radiographic evaluation of the bone density around each implant was done using OnDemand3D™.
  measure: the mean value of Marginal bone loss
  time frame: up to 9months
  description: marginal bone levels were calculated from the reconstructed corrected sagittal views by drawing a line parallel to the implant serration extending from the crestal bone to the apical end of the implant. Average readings of the two sides at each interval were calculated and tabulated for statistical analysis.
  measure: the mean of peri-implant probing depth
  time frame: up to 9 months
  description: Probing depth was assessed according to Gallagher and Silver Probing pocket depth refers to the distance between the gingival margin and the bottom of the pocket
  arm group label: non-restorable mandibular molar teeth
  arm group type: Other
  description: patients with non restorable mandibular molar teeth without any periapical pathosis to be extracted and implanted immediately using ultrawide diameter dental implants
  intervention type: Procedure
  intervention name: Immediate implant placement of Ultrawide diameter dental implants
  description: immediate placement of ultrawide diameter dental implants in a fresh extraction socket of mandibular molar teeth
  arm group label: non-restorable mandibular molar teeth
  other name: Ultrawide diameter dental implants
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 40 Years
  healthy volunteers: No
  last name: Gaafar N Elhalawani
  role: Study Director
  affiliation: Alexandria University
  facility: 
  country: Egypt
  responsible party type: Sponsor-Investigator
  investigator affiliation: Alexandria University
  investigator full name: Abdelrahman Elshahawy
  investigator title: principle investigator
  sharing ipd: No
  provided document: 