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/NCT06017193</url>
    </required_header>
    <id_info>
      <org_study_id>HUM00226516</org_study_id>
      <secondary_id>1R01DE030872</secondary_id>
      <nct_id>NCT06017193</nct_id>
    </id_info>
    <brief_title>Ultrasound for Socket Healing Evaluation</brief_title>
    <official_title>Ultrasonic Imaging of Bone Graft Healing in Extraction Sockets for Precise and Personalized Implant Therapy (HUM00226516)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Michigan</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute of Dental and Craniofacial Research (NIDCR)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Michigan</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 design is a single blinded, dual comparative study of ultrasound versus micro-CT/LASCA in&#xD;
        one study group. Up to a total of 140 subjects registered will be recruited. Subjects who are&#xD;
        treatment planned for extraction of a hopeless tooth and socket augmentation with bone graft&#xD;
        and are planned for a dental implant surgery. The socket will be evaluated before the&#xD;
        extraction and multi-time points during healing until an implant is placed with various&#xD;
        evaluation tools, including ultrasound.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The design is a single blinded, dual comparative study of ultrasound versus micro-CT/LASCA in&#xD;
        one study group. Up to a total of 140 subjects registered will be recruited. Subjects who are&#xD;
        treatment planned for extraction of a hopeless tooth and socket augmentation with bone graft&#xD;
        and are planned for a dental implant surgery. Qualified subjects will be asked during their&#xD;
        pre-assessment visit. Subjects will be scanned with ultrasound and LASCA among other&#xD;
        assessments shown in the info-graph and schedule of events. At the day of tooth extraction&#xD;
        and socket augmentation (graft placement), clinical exams/measurements are taken, along with&#xD;
        other research activities described in the info-graph and schedule of events. Recovery&#xD;
        (checkups) from surgery will be monitored at 2 weeks, 1 month and 2 months, and 3 months. The&#xD;
        timepoints additional to normal clinical timepoints are needed to gather potentially&#xD;
        diagnostic valuable information about graft maturation, which in the future may lead to an&#xD;
        early graft failure decision or trigger other clinical steps such as infection management.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">March 1, 2026</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Primary Objective</measure>
      <time_frame>approximately 6 months</time_frame>
      <description>To determine if bone graft maturation can be imaged by ultrasound. Bone healing by ultrasound will be given a scale and will be compared to the reference standard micro-computed tomography (micro-CT) of tissue core biopsy taken at implant surgery</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Secondary Objective</measure>
      <time_frame>approximately 6 months</time_frame>
      <description>To determine if bone graft maturation can be imaged by ultrasound, by comparing to clinical healing appearances. A score will be given to ultrasound image and clinical outcome and the correlation will be evaluated.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">140</enrollment>
    <condition>Healing Wound</condition>
    <condition>Alveolar; Wound</condition>
    <condition>Alveolar Bone Loss</condition>
    <condition>Image</condition>
    <condition>Dent Disease</condition>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Tissue core biopsy from healed sockets.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Subjects who are treatment planned for extraction of a hopeless tooth and socket&#xD;
          augmentation with bone graft and are planned for a dental implant surgery.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients at least 18 years of age and have at least a tooth that is considered&#xD;
               hopeless, planned for an extraction and a bone grafting procedure for subsequent&#xD;
               dental implant surgery.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients not willing or not able to have an extraction, bone graft and subsequent&#xD;
               implant surgery due to health, finance, or any other reasons.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hsun-Liang Chan, DDS, MS</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Michigan</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Oliver Kripfgans, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Michigan, Radiology</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hsun-Liang Chan, DDS, MS</last_name>
      <phone>734-763-9539</phone>
      <email>hlchan@umich.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Oliver Kripfgans, PhD</last_name>
      <phone>734-647-0852</phone>
      <email>oliver.kripfgans@umich.edu</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Michigan</investigator_affiliation>
      <investigator_full_name>Hsun-Liang Chan</investigator_full_name>
      <investigator_title>Assistant Program Director, Periodontics Graduate Program</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Alveolar Bone Loss</mesh_term>
      <mesh_term>Dent Disease</mesh_term>
      <mesh_term>Wounds and Injuries</mesh_term>
    </condition_browse>
    <!-- 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/NCT06017193
  org study id: HUM00226516
  secondary id: 1R01DE030872
  nct id: NCT06017193
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The design is a single blinded, dual comparative study of ultrasound versus micro-CT/LASCA in
        one study group. Up to a total of 140 subjects registered will be recruited. Subjects who are
        treatment planned for extraction of a hopeless tooth and socket augmentation with bone graft
        and are planned for a dental implant surgery. The socket will be evaluated before the
        extraction and multi-time points during healing until an implant is placed with various
        evaluation tools, including ultrasound.
  The design is a single blinded, dual comparative study of ultrasound versus micro-CT/LASCA in
        one study group. Up to a total of 140 subjects registered will be recruited. Subjects who are
        treatment planned for extraction of a hopeless tooth and socket augmentation with bone graft
        and are planned for a dental implant surgery. Qualified subjects will be asked during their
        pre-assessment visit. Subjects will be scanned with ultrasound and LASCA among other
        assessments shown in the info-graph and schedule of events. At the day of tooth extraction
        and socket augmentation (graft placement), clinical exams/measurements are taken, along with
        other research activities described in the info-graph and schedule of events. Recovery
        (checkups) from surgery will be monitored at 2 weeks, 1 month and 2 months, and 3 months. The
        timepoints additional to normal clinical timepoints are needed to gather potentially
        diagnostic valuable information about graft maturation, which in the future may lead to an
        early graft failure decision or trigger other clinical steps such as infection management.
  observational model: Cohort
  time perspective: Prospective
  measure: Primary Objective
  time frame: approximately 6 months
  description: To determine if bone graft maturation can be imaged by ultrasound. Bone healing by ultrasound will be given a scale and will be compared to the reference standard micro-computed tomography (micro-CT) of tissue core biopsy taken at implant surgery
  measure: Secondary Objective
  time frame: approximately 6 months
  description: To determine if bone graft maturation can be imaged by ultrasound, by comparing to clinical healing appearances. A score will be given to ultrasound image and clinical outcome and the correlation will be evaluated.
  Tissue core biopsy from healed sockets.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Hsun-Liang Chan, DDS, MS
  role: Principal Investigator
  affiliation: University of Michigan
  last name: Oliver Kripfgans, PhD
  role: Principal Investigator
  affiliation: University of Michigan, Radiology
  last name: Hsun-Liang Chan, DDS, MS
  phone: 734-763-9539
  email: hlchan@umich.edu
  last name: Oliver Kripfgans, PhD
  phone: 734-647-0852
  email: oliver.kripfgans@umich.edu
  responsible party type: Principal Investigator
  investigator affiliation: University of Michigan
  investigator full name: Hsun-Liang Chan
  investigator title: Assistant Program Director, Periodontics Graduate Program
  mesh term: Alveolar Bone Loss
  mesh term: Dent Disease
  mesh term: Wounds and Injuries