<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/NCT02217774</url>
  </required_header>
  <id_info>
    <org_study_id>0210-14-RMB CTIL</org_study_id>
    <secondary_id>0210-14-RMB</secondary_id>
    <nct_id>NCT02217774</nct_id>
  </id_info>
  <brief_title>MGUIDE MORE Dental Implant Planning System- Clinical Accuracy Study</brief_title>
  <official_title>MGUIDE MORE Dental Implant Planning System- Clinical Accuracy Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rambam Health Care Campus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>MIS Implant Technologies, Ltd</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Rambam Health Care Campus</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the present study is to assess the accuracy of MGUIDE MORE System (MGS),&#xD;
      consisting of MGUIDE MORE software, MGUIDE MORE surgical kit and MGUIDE MORE template by&#xD;
      evaluating the difference between planned and actual implant positions on pre- and&#xD;
      post-operative CBCTs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients, attending the Department of Periodontology at the Rambam School of Graduate&#xD;
      Dentistry, who are scheduled for implant therapy, will be screened for the study. Patients&#xD;
      will be referred for CBCT of the upper/lower jaw as appropriate. DICOM data of the patient&#xD;
      will be uploaded to MGUIDE software and used for diagnosis and treatment planning of the&#xD;
      case. Surgery will be performed using MGUIDE MORE template and MGUIDE MORE surgical kit.&#xD;
      Pre-operative and post-operative CBCT will be used for assessment of the difference between&#xD;
      planned and actual implant positions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">August 23, 2015</completion_date>
  <primary_completion_date type="Actual">August 23, 2015</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Deviation from planning</measure>
    <time_frame>0-14 days after implant placement</time_frame>
    <description>To assess shoulder and apex deviations in milimeters between planned and actual implant position and to assess angular deviation in degrees, of actual implant position vs. planned implant position</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Focus of Study: Computer-Aided Design/Instrumentation</condition>
  <arm_group>
    <arm_group_label>MGUIDE assisted implant placement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Implant placement, using MGUIDE MORE system for implant planning and placement</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MGUIDE MORE</intervention_name>
    <description>MGUIDE MORE System (MGS), consisting of MGUIDE MORE software, MGUIDE MORE surgical kit and MGUIDE MORE template, will be used for planning, drilling and inserting dental implants.</description>
    <arm_group_label>MGUIDE assisted implant placement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed and dated inform consent form.&#xD;
&#xD;
          -  Age between 18+.&#xD;
&#xD;
          -  Patient expresses his wish to restore the missing tooth/teeth with dental implants.&#xD;
&#xD;
          -  Patient is examined and found suitable for implant therapy&#xD;
&#xD;
          -  Patient can open mouth sufficiently for preparation and placement of dental implants&#xD;
             using the contra-angle handpiece and drills.&#xD;
&#xD;
          -  CBCT is required for proper diagnosis and treatment planning.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#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>Jacob Horwitz, DMD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rambam Health Care Campus</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rambam Health Care Campus</name>
      <address>
        <city>Haifa</city>
        <zip>3109601</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <reference>
    <citation>Horwitz J, Zuabi O, Machtei EE. Accuracy of a computerized tomography-guided template-assisted implant placement system: an in vitro study. Clin Oral Implants Res. 2009 Oct;20(10):1156-62. doi: 10.1111/j.1600-0501.2009.01748.x. Epub 2009 Jun 10.</citation>
    <PMID>19519787</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>September 27, 2017</last_update_submitted>
  <last_update_submitted_qc>September 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Computer-Aided Design/instrumentation</keyword>
  <keyword>Cone-Beam Computed Tomography</keyword>
  <keyword>Dental Implant</keyword>
  <keyword>MGuide</keyword>
  <!-- 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/NCT02217774
org study id: 0210-14-RMB CTIL
secondary id: 0210-14-RMB
nct id: NCT02217774
lead sponsor: 
collaborator: 
has dmc: No
The aim of the present study is to assess the accuracy of MGUIDE MORE System (MGS),
      consisting of MGUIDE MORE software, MGUIDE MORE surgical kit and MGUIDE MORE template by
      evaluating the difference between planned and actual implant positions on pre- and
      post-operative CBCTs.
Patients, attending the Department of Periodontology at the Rambam School of Graduate
      Dentistry, who are scheduled for implant therapy, will be screened for the study. Patients
      will be referred for CBCT of the upper/lower jaw as appropriate. DICOM data of the patient
      will be uploaded to MGUIDE software and used for diagnosis and treatment planning of the
      case. Surgery will be performed using MGUIDE MORE template and MGUIDE MORE surgical kit.
      Pre-operative and post-operative CBCT will be used for assessment of the difference between
      planned and actual implant positions.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Deviation from planning
time frame: 0-14 days after implant placement
description: To assess shoulder and apex deviations in milimeters between planned and actual implant position and to assess angular deviation in degrees, of actual implant position vs. planned implant position
arm group label: MGUIDE assisted implant placement
arm group type: Experimental
description: Implant placement, using MGUIDE MORE system for implant planning and placement
intervention type: Device
intervention name: MGUIDE MORE
description: MGUIDE MORE System (MGS), consisting of MGUIDE MORE software, MGUIDE MORE surgical kit and MGUIDE MORE template, will be used for planning, drilling and inserting dental implants.
arm group label: MGUIDE assisted implant placement
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jacob Horwitz, DMD
role: Principal Investigator
affiliation: Rambam Health Care Campus
facility: 
country: Israel
citation: Horwitz J, Zuabi O, Machtei EE. Accuracy of a computerized tomography-guided template-assisted implant placement system: an in vitro study. Clin Oral Implants Res. 2009 Oct;20(10):1156-62. doi: 10.1111/j.1600-0501.2009.01748.x. Epub 2009 Jun 10.
PMID: 19519787
responsible party type: Sponsor