<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/NCT02221206</url>
  </required_header>
  <id_info>
    <org_study_id>NSF81371167</org_study_id>
    <nct_id>NCT02221206</nct_id>
  </id_info>
  <brief_title>Volumetric Analysis of Root Resorption With Mini-Screw Implant Anchorage-assisted Retraction of Maxillary Incisors</brief_title>
  <official_title>Clinical Observation for the Root Resorption With Mini-Screw Implant Anchorage-assisted Retraction of Maxillary Incisors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zhejiang University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The intended study is designed as a prospective randomized controlled trial (RCT), comparing&#xD;
      and contrasting the effect of mini-screw implant anchorage-assisted versus regular maximum&#xD;
      anchorage by retracting the maxillary incisors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of the clinical study proposal will be to investigate the performance of early&#xD;
      root resorption in order to find out if the magnitude and direction of retraction is&#xD;
      appropriate for the retraction of maxillary incisors following the mini-screw anchorage.&#xD;
&#xD;
      Therefore, the study will compare and contrast the efficacy and results of the volumetric&#xD;
      measurement by CBCT.&#xD;
&#xD;
      Patients&#xD;
&#xD;
      Males or females whose diagnoses require implant anchorage treatment will be included in the&#xD;
      study. Inclusion criteria for the study are as followings:&#xD;
&#xD;
      Orthodontic indication for skeletal anchorage Adequate bone quantity for a palatal implant in&#xD;
      the CBCT Good oral hygiene and normal wound healing capacity&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">December 2015</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Root resorption</measure>
    <time_frame>10 months after implant insertion</time_frame>
    <description>orthodontic analysis was done by a Cone beam computed tomography (CBCT) analysis</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Dental Dysgnathia</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>mini-screw implant anchorage-assisted retraction of maxillary incisors</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>regular maximum anchorage</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mini-Screw implant</intervention_name>
    <description>Mini-screw implants (VectorTASTM8*1.4mm, Ormco Corporation, USA) were placed between maxillary first molar and second molar after local anesthetic on both sides</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Orthodontic indication for skeletal anchorage&#xD;
&#xD;
          -  Adequate bone quantity for a palatal implant in the CBCT&#xD;
&#xD;
          -  Good oral hygiene and normal wound healing capacity&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with cheilognathopalatoschisis and other system syndromes associated with&#xD;
             craniofacial anomalies&#xD;
&#xD;
          -  Patients with immunodeficiency, diseases requiring a prolonged steroid usage, previous&#xD;
             radiation therapy or chemotherapy&#xD;
&#xD;
          -  Patients with metabolic bone diseases or uncontrolled endocrine disorders&#xD;
&#xD;
          -  Alcohol or drug abuse&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mengjie Wu, MD, DDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Orthodontics, Hospital of Stomatology, Zhejiang University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Orthodontics, Hospital of Stomatology, Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 18, 2014</study_first_submitted>
  <study_first_submitted_qc>August 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>September 17, 2014</last_update_submitted>
  <last_update_submitted_qc>September 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zhejiang University</investigator_affiliation>
    <investigator_full_name>Mengjie Wu</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Mini-Screw implant anchorage</keyword>
  <keyword>retraction of maxillary incisors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Root Resorption</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/NCT02221206
org study id: NSF81371167
nct id: NCT02221206
lead sponsor: 
has dmc: Yes
The intended study is designed as a prospective randomized controlled trial (RCT), comparing
      and contrasting the effect of mini-screw implant anchorage-assisted versus regular maximum
      anchorage by retracting the maxillary incisors.
The objective of the clinical study proposal will be to investigate the performance of early
      root resorption in order to find out if the magnitude and direction of retraction is
      appropriate for the retraction of maxillary incisors following the mini-screw anchorage.

      Therefore, the study will compare and contrast the efficacy and results of the volumetric
      measurement by CBCT.

      Patients

      Males or females whose diagnoses require implant anchorage treatment will be included in the
      study. Inclusion criteria for the study are as followings:

      Orthodontic indication for skeletal anchorage Adequate bone quantity for a palatal implant in
      the CBCT Good oral hygiene and normal wound healing capacity
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Root resorption
time frame: 10 months after implant insertion
description: orthodontic analysis was done by a Cone beam computed tomography (CBCT) analysis
arm group label: Treatment
arm group type: Active Comparator
description: mini-screw implant anchorage-assisted retraction of maxillary incisors
arm group label: Control
arm group type: No Intervention
description: regular maximum anchorage
intervention type: Device
intervention name: Mini-Screw implant
description: Mini-screw implants (VectorTASTM8*1.4mm, Ormco Corporation, USA) were placed between maxillary first molar and second molar after local anesthetic on both sides
arm group label: Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 25 Years
healthy volunteers: No
last name: Mengjie Wu, MD, DDS
role: Principal Investigator
affiliation: Department of Orthodontics, Hospital of Stomatology, Zhejiang University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Zhejiang University
investigator full name: Mengjie Wu
investigator title: Associate Professor
mesh term: Root Resorption