<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/NCT04488302</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00179671</org_study_id>
    <nct_id>NCT04488302</nct_id>
  </id_info>
  <brief_title>Ultrasonography and Cone-Beam Computed Tomography for Peri-implant Tissue Evaluation</brief_title>
  <official_title>A Retrospective Study on Use of Ultrasonography and Cone-Beam Computed Tomography for Evaluating Peri-implant Tissue</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Michigan</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>
      Objectives: Although cone-beam computed tomography (CBCT) is becoming a standard of care in&#xD;
      implant therapy, concerns have been raised recently about its limitation in imaging&#xD;
      peri-implant tissues due to artifacts. The aim of present study was to demonstrate the&#xD;
      complementary role of ultrasound (US), for a comprehensive examination of peri-implant&#xD;
      tissues in live humans. Material and Methods: Patients with &gt; 1 implant, a CBCT scan, an US&#xD;
      scan, and clinical photographs taken during the open-bone surgery were included. The crestal&#xD;
      bone thickness (CBT) and facial bone level (FBL) were measured on both modalities, and direct&#xD;
      FBL measurements were also made on clinical images. The correlation plots were made to&#xD;
      evaluate the measurement agreements between the 3 methods.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2019</start_date>
  <completion_date type="Actual">July 7, 2020</completion_date>
  <primary_completion_date type="Actual">May 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Crestal bone thickness</measure>
    <time_frame>up to 100 months after implant surgery.</time_frame>
    <description>facial bone thickness measured at 1 mm apical to bone crest</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Facial bone height</measure>
    <time_frame>up to 100 months after implant surgery.</time_frame>
    <description>facial bone height measured from implant platform</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">4</enrollment>
  <condition>Ultrasonography</condition>
  <arm_group>
    <arm_group_label>Implant group</arm_group_label>
    <description>Patients with 1 or more implants with CBCT, ultrasound and open-bone images</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        See eligibility criteria&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  the patients had to have ≥ 1 implant with a CBCT scan, US scan, and clinical&#xD;
             photographs taken during the surgery, e.g. a revision/explantation surgery due to&#xD;
             peri-implantitis or a 2nd stage uncover surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>July 24, 2020</last_update_submitted>
  <last_update_submitted_qc>July 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2020</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>Clinical Associate Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No share with others</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04488302
org study id: HUM00179671
nct id: NCT04488302
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Objectives: Although cone-beam computed tomography (CBCT) is becoming a standard of care in
      implant therapy, concerns have been raised recently about its limitation in imaging
      peri-implant tissues due to artifacts. The aim of present study was to demonstrate the
      complementary role of ultrasound (US), for a comprehensive examination of peri-implant
      tissues in live humans. Material and Methods: Patients with > 1 implant, a CBCT scan, an US
      scan, and clinical photographs taken during the open-bone surgery were included. The crestal
      bone thickness (CBT) and facial bone level (FBL) were measured on both modalities, and direct
      FBL measurements were also made on clinical images. The correlation plots were made to
      evaluate the measurement agreements between the 3 methods.
observational model: Case-Only
time perspective: Retrospective
measure: Crestal bone thickness
time frame: up to 100 months after implant surgery.
description: facial bone thickness measured at 1 mm apical to bone crest
measure: Facial bone height
time frame: up to 100 months after implant surgery.
description: facial bone height measured from implant platform
arm group label: Implant group
description: Patients with 1 or more implants with CBCT, ultrasound and open-bone images
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Hsun-Liang Chan
investigator title: Clinical Associate Professor
sharing ipd: No
ipd description: No share with others