<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/NCT04487379</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00183733</org_study_id>
    <nct_id>NCT04487379</nct_id>
  </id_info>
  <brief_title>Ultrasound Crestal Bone Topography of Edentulous Ridges</brief_title>
  <official_title>Evaluation of Crestal Bone Topography of Edentulous Ridges: A Retrospective Study Comparing Ultrasonography to Cone-Beam Computed Tomography (CBCT)</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>
      A successful implant surgery primarily relies on a prudent evaluation of oral anatomy and&#xD;
      meticulous treatment planning. Additionally, of paramount importance that dictates the types&#xD;
      of procedures, material selection and ultimately success of implant surgery is the quality&#xD;
      and quantity of the edentulous ridge. Ultrasound imaging (US), another cross-sectional&#xD;
      imaging modality, has been extensively used in the medical diagnostics field. The ability of&#xD;
      ultrasound to image soft tissue-bone interface makes it particularly promising for studying&#xD;
      bone ridge width and crestal bone topography. Therefore, this retrospective human study aimed&#xD;
      to compare bone width measurements between US and CBCT. This study also investigated the&#xD;
      possible correlation between the crestal bone surface quality imaged by US and CBCT.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 16, 2020</start_date>
  <completion_date type="Actual">December 1, 2020</completion_date>
  <primary_completion_date type="Actual">December 1, 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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Accuracy of ultrasound for estimating ridge width</measure>
    <time_frame>up to 3 months after image was taken</time_frame>
    <description>measure the edentulous ridge width at 1, 2 and 3 mm apical to the crest on ultrasound images</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Accuracy of ultrasound for assessing ridge surface quality</measure>
    <time_frame>up to 3 months after image was taken</time_frame>
    <description>Evaluate the crestal bone surface quality with ultrasound</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">28</enrollment>
  <condition>Ultrasonography</condition>
  <arm_group>
    <arm_group_label>Group with edentulous ridge</arm_group_label>
    <description>This group had edentulous ridge planning to receive a dental implant and had ultrasound and cone-beam computed tomography images of the ridge.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Records of patients who had at least 1 edentulous ridge with a plan for implant placement,&#xD;
        had cone-beam computed tomography as standard procedure and ultrasound imaging for&#xD;
        off-label use of evaluating the ridge were included.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient records at the Graduate Periodontal Clinic&#xD;
&#xD;
          -  With both US and CBCT scans taking within 3 months between each other from Jan 2016 to&#xD;
             Mar 2020&#xD;
&#xD;
          -  These images had to include at least one edentulous ridge at the anterior, premolar or&#xD;
             molar site.&#xD;
&#xD;
          -  Multiple sites in a given patient may be included.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Michigan School of Dentistry</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>January 2021</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>January 13, 2021</last_update_submitted>
  <last_update_submitted_qc>January 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2021</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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mouth, Edentulous</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Not plan to share IPD.</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/NCT04487379
org study id: HUM00183733
nct id: NCT04487379
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A successful implant surgery primarily relies on a prudent evaluation of oral anatomy and
      meticulous treatment planning. Additionally, of paramount importance that dictates the types
      of procedures, material selection and ultimately success of implant surgery is the quality
      and quantity of the edentulous ridge. Ultrasound imaging (US), another cross-sectional
      imaging modality, has been extensively used in the medical diagnostics field. The ability of
      ultrasound to image soft tissue-bone interface makes it particularly promising for studying
      bone ridge width and crestal bone topography. Therefore, this retrospective human study aimed
      to compare bone width measurements between US and CBCT. This study also investigated the
      possible correlation between the crestal bone surface quality imaged by US and CBCT.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Accuracy of ultrasound for estimating ridge width
time frame: up to 3 months after image was taken
description: measure the edentulous ridge width at 1, 2 and 3 mm apical to the crest on ultrasound images
measure: Accuracy of ultrasound for assessing ridge surface quality
time frame: up to 3 months after image was taken
description: Evaluate the crestal bone surface quality with ultrasound
arm group label: Group with edentulous ridge
description: This group had edentulous ridge planning to receive a dental implant and had ultrasound and cone-beam computed tomography images of the ridge.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
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
mesh term: Mouth, Edentulous
sharing ipd: No
ipd description: Not plan to share IPD.