<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/NCT01717417</url>
  </required_header>
  <id_info>
    <org_study_id>MVM1</org_study_id>
    <secondary_id>GU-1</secondary_id>
    <nct_id>NCT01717417</nct_id>
  </id_info>
  <brief_title>Three Dimensional Movement Analysis of Maxillary Impacted Canine: a Randomized Clincial Trial</brief_title>
  <official_title>Three Dimensional Movement Analysis of Maxillary Impacted Canine Using TADs: a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Genova</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Genova</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Maxillary canines are the second-most frequently impacted teeth in the dental arch after the&#xD;
      third molars. The suspicion of a maxilary canine impaction raises with the absence of the&#xD;
      permanent canine in the arch after the normal period of eruption, and has to be confirmed by&#xD;
      a clinical evaluation of the patient and a radiographic assessment.&#xD;
&#xD;
      The approaches to the management of impacted canines are many, but the preferred approach&#xD;
      typically involves surgical exposure and guided orthodontic eruption.&#xD;
&#xD;
      The initial mechanical eruption can be achieved in several ways, but an important distinction&#xD;
      has to be done according to the anchorage method. The aim of this study is comparing&#xD;
      Temporary Anchorage Devices (TADs), and cantilevers with a TMA sectional, using the&#xD;
      quantification of canines and molars displacement as the main parameter.&#xD;
&#xD;
      A TAD is a mini screw temporarily fixed to bone for the purpose of enhancing orthodontic&#xD;
      anchorage either by supporting the reactive unit (the anchoring tooth) or by obviating the&#xD;
      need for it at large, and is subsequently removed after use.&#xD;
&#xD;
      The mini screw employed in this clinical trial will be an alloy type IV titanium screw with&#xD;
      1.5mm diameter and 8-10 mm long, and under local anesthesia will be placed in an area between&#xD;
      the first premolar and first molar, on the buccal or labial side according to the canine&#xD;
      position and teeth position.&#xD;
&#xD;
      For the evaluation of the canines and molar displacement, two CBCT will be required: the&#xD;
      first one before the beginning of the traction (T0), the second one after three months (T1).&#xD;
      Both the CBCT will be imported in the MIMICS image processing software (Materialize Group,&#xD;
      Leuven, Belgium). Limiting the tissue density ranges and restricting the anatomical area of&#xD;
      interest, a cropped colored mask will be obtained from each CBCT. Then the co-registration,&#xD;
      through the identification of 5 at least landmark points, will allow the overlap of the two&#xD;
      masks. At this point, calculating the 3D surface models, the tooth pre- and post-treatment&#xD;
      positions will be evident and the measurement of the displacement possible.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">April 14, 2019</completion_date>
  <primary_completion_date type="Actual">April 1, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>4 Months</target_duration>
  <primary_outcome>
    <measure>Canine movement</measure>
    <time_frame>baseline and 3 months after starting treatment</time_frame>
    <description>Superimposition of two consecutive TC cone beam using at least 5 landmarks point. Calculation of the 3D surface model and the measureament of the canine and first molar movement</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Side effect of traction</measure>
    <time_frame>baseline and end of treatment</time_frame>
    <description>Evaluation of Root cervical resorption of other teeth due to canine movement Bone density after three month of traction</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">16</enrollment>
  <condition>Complicated Impacted Tooth</condition>
  <arm_group>
    <arm_group_label>group 1</arm_group_label>
    <description>Patient treated with Trans Palatal Arch as anchorage for canine traction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <description>Patient treated with miniscrew as anchorage for canine traction</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>miniscrew</intervention_name>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TPA</intervention_name>
    <arm_group_label>group 1</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients referred to the Orthodontic Department, Genoa University.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  presence of one or two impacted maxillary canine requiring surgical exposure and&#xD;
             orthodontic treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  permanent teeth extraction-based treatment&#xD;
&#xD;
          -  current or previous orthodontic treatment in the last 12 months&#xD;
&#xD;
          -  current systemic disease&#xD;
&#xD;
          -  current antibiotic or antinflammatory therapy that can may compromise the result&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Armando Silvestrini Biavati, MD, DDS</last_name>
    <role>Study Director</role>
    <affiliation>Genoa University, Italy</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marco Migliorati, DDS, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Genoa University, Italy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Orthodontics Department, Dental School, Genoa University. Italy</name>
      <address>
        <city>Genoa</city>
        <zip>16100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>October 26, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>April 14, 2019</last_update_submitted>
  <last_update_submitted_qc>April 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Genova</investigator_affiliation>
    <investigator_full_name>Marco Migliorati</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <keyword>impacted canine</keyword>
  <keyword>miniscrew</keyword>
  <keyword>cone beam</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tooth, Impacted</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/NCT01717417
org study id: MVM1
secondary id: GU-1
nct id: NCT01717417
lead sponsor: 
collaborator: 
has dmc: No
Maxillary canines are the second-most frequently impacted teeth in the dental arch after the
      third molars. The suspicion of a maxilary canine impaction raises with the absence of the
      permanent canine in the arch after the normal period of eruption, and has to be confirmed by
      a clinical evaluation of the patient and a radiographic assessment.

      The approaches to the management of impacted canines are many, but the preferred approach
      typically involves surgical exposure and guided orthodontic eruption.

      The initial mechanical eruption can be achieved in several ways, but an important distinction
      has to be done according to the anchorage method. The aim of this study is comparing
      Temporary Anchorage Devices (TADs), and cantilevers with a TMA sectional, using the
      quantification of canines and molars displacement as the main parameter.

      A TAD is a mini screw temporarily fixed to bone for the purpose of enhancing orthodontic
      anchorage either by supporting the reactive unit (the anchoring tooth) or by obviating the
      need for it at large, and is subsequently removed after use.

      The mini screw employed in this clinical trial will be an alloy type IV titanium screw with
      1.5mm diameter and 8-10 mm long, and under local anesthesia will be placed in an area between
      the first premolar and first molar, on the buccal or labial side according to the canine
      position and teeth position.

      For the evaluation of the canines and molar displacement, two CBCT will be required: the
      first one before the beginning of the traction (T0), the second one after three months (T1).
      Both the CBCT will be imported in the MIMICS image processing software (Materialize Group,
      Leuven, Belgium). Limiting the tissue density ranges and restricting the anatomical area of
      interest, a cropped colored mask will be obtained from each CBCT. Then the co-registration,
      through the identification of 5 at least landmark points, will allow the overlap of the two
      masks. At this point, calculating the 3D surface models, the tooth pre- and post-treatment
      positions will be evident and the measurement of the displacement possible.
observational model: Cohort
time perspective: Prospective
measure: Canine movement
time frame: baseline and 3 months after starting treatment
description: Superimposition of two consecutive TC cone beam using at least 5 landmarks point. Calculation of the 3D surface model and the measureament of the canine and first molar movement
measure: Side effect of traction
time frame: baseline and end of treatment
description: Evaluation of Root cervical resorption of other teeth due to canine movement Bone density after three month of traction
arm group label: group 1
description: Patient treated with Trans Palatal Arch as anchorage for canine traction
arm group label: Group 2
description: Patient treated with miniscrew as anchorage for canine traction
intervention type: Device
intervention name: miniscrew
arm group label: Group 2
intervention type: Device
intervention name: TPA
arm group label: group 1
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 10 Years
maximum age: 60 Years
healthy volunteers: No
last name: Armando Silvestrini Biavati, MD, DDS
role: Study Director
affiliation: Genoa University, Italy
last name: Marco Migliorati, DDS, MSc
role: Principal Investigator
affiliation: Genoa University, Italy
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Genova
investigator full name: Marco Migliorati
investigator title: Doctor
mesh term: Tooth, Impacted