<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/NCT02221856</url>
  </required_header>
  <id_info>
    <org_study_id>Masoud-001</org_study_id>
    <nct_id>NCT02221856</nct_id>
  </id_info>
  <brief_title>A Comparison of the Alignment Achieved Using Computer-guided Indirect Bonding of Orthodontic Brackets to Conventional Appliance Placement</brief_title>
  <official_title>A Prospective Clinical Trial Comparing the Alignment Achieved Using Computer-guided Indirect Bonding of Orthodontic Brackets to Conventional Orthodontic Appliance Placement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Harvard School of Dental Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Harvard School of Dental Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Technological advances have made computer aided orthodontic treatment planning possible. 3D&#xD;
      dental scanners and software make it possible to design and approve the outcome before&#xD;
      treatment begins. Manufacturers have provided different customized appliance systems that&#xD;
      would help practitioners achieve those computer-designed outcomes. The purpose of this study&#xD;
      is to determine the accuracy of computer-guided indirect bonding of orthodontic brackets at&#xD;
      achieving the predicted alignment and comparing that to the accuracy of conventional&#xD;
      orthodontic bracket placement at achieving a predetermined goal. The results of this study&#xD;
      will help orthodontists and patients know if there is an advantage to using custom&#xD;
      appliances. The study will be a prospective clinical study and will include a total of 60&#xD;
      arches from 30 patients enrolled at the Harvard School of Dental Medicine. 15 patients will&#xD;
      be assigned to each of the two study groups (Motion View or control). Both groups will have a&#xD;
      3D intra-oral scan to measure the initial discrepancy and determine the computer-simulated&#xD;
      design that the orthodontist believes is the optimized outcome. At the end of each patient's&#xD;
      participation, a 3D intraoral scan will be taken and used to assess intra-arch leveling and&#xD;
      alignment using ABO's objective grading system's criteria for alignment, marginal ridges and&#xD;
      buccolingual inclination. Each arch will then be superimposed on the predicted outcome to&#xD;
      determine how accurate each system was at achieving the planned movements in all 3&#xD;
      dimensions. We hypothesize that the accuracy of computer-guided indirect bonding (Motion&#xD;
      View) at achieving the predicted outcomes will differ in comparison to the accuracy of&#xD;
      conventional orthodontic bracket placement at achieving a predetermined goal.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 8, 2017</start_date>
  <completion_date type="Anticipated">May 2018</completion_date>
  <primary_completion_date type="Anticipated">May 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Discrepancy between predicated and actual tooth positions</measure>
    <time_frame>up to 12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>assessed quality of treatment measured by the American Board of Orthodontics (ABO) objective grading system</measure>
    <time_frame>up to 12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Malocclusion</condition>
  <arm_group>
    <arm_group_label>Motion View</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional Orthodontic Treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Motion View</intervention_name>
    <description>Motion View, a software we are using to place brackets virtually on a 3D rendition of a patients teeth, will be used to indirectly bond brackets onto patient's teeth with a 3D printed plastic transfer JIG in which the brackets will be precisely placed on the patients teeth according to the computer-guided software.</description>
    <arm_group_label>Motion View</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conventional Orthodontic Treatment</intervention_name>
    <description>orthodontic treatment using non-customized brackets and stock wires</description>
    <arm_group_label>Conventional Orthodontic Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy subjects seeking orthodontic care&#xD;
&#xD;
          -  All permanent teeth must be erupted, excluding second and third molars&#xD;
&#xD;
          -  Class I, II, and III cases&#xD;
&#xD;
          -  No more than 7 mm crowding&#xD;
&#xD;
          -  No more than 45 degrees of rotations&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of systemic disease&#xD;
&#xD;
          -  Craniofacial anomalies, including cleft lip and palate&#xD;
&#xD;
          -  Syndromes affecting bone or teeth&#xD;
&#xD;
          -  Congenitally missing teeth, excluding third molars&#xD;
&#xD;
          -  Presence of bridges or implants&#xD;
&#xD;
          -  Periodontal disease&#xD;
&#xD;
          -  Use of drugs affecting tooth movement or bone metabolism (NSAIDS, bisphosphonates,&#xD;
             PTH, corticosteroids)&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohamed Masoud, BDS, DMSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Harvard School of Dental Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mohamed Masoud, BDS, DMSc</last_name>
    <phone>617-432-4281</phone>
    <email>Mohamed_Masoud@hsdm.harvard.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Harvard School of Dental Medicine</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mohamed Masoud</last_name>
    </contact>
    <investigator>
      <last_name>Mohamed Masoud, BDS, DMSc</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>August 15, 2014</study_first_submitted>
  <study_first_submitted_qc>August 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2014</study_first_posted>
  <last_update_submitted>February 7, 2017</last_update_submitted>
  <last_update_submitted_qc>February 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Harvard School of Dental Medicine</investigator_affiliation>
    <investigator_full_name>Mohamed Masoud</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Conventional orthodontic treatment</keyword>
  <keyword>Motion View</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malocclusion</mesh_term>
  </condition_browse>
  <!-- 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/NCT02221856
org study id: Masoud-001
nct id: NCT02221856
lead sponsor: 
has dmc: Yes
Technological advances have made computer aided orthodontic treatment planning possible. 3D
      dental scanners and software make it possible to design and approve the outcome before
      treatment begins. Manufacturers have provided different customized appliance systems that
      would help practitioners achieve those computer-designed outcomes. The purpose of this study
      is to determine the accuracy of computer-guided indirect bonding of orthodontic brackets at
      achieving the predicted alignment and comparing that to the accuracy of conventional
      orthodontic bracket placement at achieving a predetermined goal. The results of this study
      will help orthodontists and patients know if there is an advantage to using custom
      appliances. The study will be a prospective clinical study and will include a total of 60
      arches from 30 patients enrolled at the Harvard School of Dental Medicine. 15 patients will
      be assigned to each of the two study groups (Motion View or control). Both groups will have a
      3D intra-oral scan to measure the initial discrepancy and determine the computer-simulated
      design that the orthodontist believes is the optimized outcome. At the end of each patient's
      participation, a 3D intraoral scan will be taken and used to assess intra-arch leveling and
      alignment using ABO's objective grading system's criteria for alignment, marginal ridges and
      buccolingual inclination. Each arch will then be superimposed on the predicted outcome to
      determine how accurate each system was at achieving the planned movements in all 3
      dimensions. We hypothesize that the accuracy of computer-guided indirect bonding (Motion
      View) at achieving the predicted outcomes will differ in comparison to the accuracy of
      conventional orthodontic bracket placement at achieving a predetermined goal.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Discrepancy between predicated and actual tooth positions
time frame: up to 12 months
measure: assessed quality of treatment measured by the American Board of Orthodontics (ABO) objective grading system
time frame: up to 12 months
arm group label: Motion View
arm group type: Experimental
arm group label: Conventional Orthodontic Treatment
arm group type: Active Comparator
intervention type: Procedure
intervention name: Motion View
description: Motion View, a software we are using to place brackets virtually on a 3D rendition of a patients teeth, will be used to indirectly bond brackets onto patient's teeth with a 3D printed plastic transfer JIG in which the brackets will be precisely placed on the patients teeth according to the computer-guided software.
arm group label: Motion View
intervention type: Procedure
intervention name: Conventional Orthodontic Treatment
description: orthodontic treatment using non-customized brackets and stock wires
arm group label: Conventional Orthodontic Treatment
criteria: 
gender: All
minimum age: N/A
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mohamed Masoud, BDS, DMSc
role: Principal Investigator
affiliation: Harvard School of Dental Medicine
last name: Mohamed Masoud, BDS, DMSc
phone: 617-432-4281
email: Mohamed_Masoud@hsdm.harvard.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Harvard School of Dental Medicine
investigator full name: Mohamed Masoud
investigator title: Principal Investigator
mesh term: Malocclusion