<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/NCT03754283</url>
  </required_header>
  <id_info>
    <org_study_id>03-05.04.2016</org_study_id>
    <nct_id>NCT03754283</nct_id>
  </id_info>
  <brief_title>Transfer Accuracy of Indirectly Bonded Orthodontic Braces With Different Transfer Trays</brief_title>
  <official_title>Transfer Accuracy of Indirectly Bonded Orthodontic Attachments With Vacuum Formed and Silicone Transfer Trays</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yuzuncu Yıl University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yuzuncu Yıl University</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>
      The aim of this study is to comparatively investigate the performances of two different and&#xD;
      widely used transfer trays during indirect bonding of the orthodontic braces.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of the study is to compare the accuracy of orthodontic bracket and tube transfer&#xD;
      between double layer silicone and double layer vacuum formed trays. The sample included 368&#xD;
      attachments bonded in 16 patients. Each patient received one silicone and one vacuum formed&#xD;
      tray which were randomly allocated to provide 8 trays of each type for the upper and lower&#xD;
      arches. 3D scan data and local best-fit alignments were used to calculate the translational&#xD;
      and rotational movements of the orthodontic attachments. Chi-square and Mann-Whitney U tests&#xD;
      were used to compare transfer accuracy and success between the groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Actual">September 1, 2017</completion_date>
  <primary_completion_date type="Actual">September 1, 2017</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>
    <intervention_model_description>1:1</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Transfer accuracy (composite outcome) in milimetres and degrees. Which is measured on computer software.</measure>
    <time_frame>Day 0 - Day 2</time_frame>
    <description>The positional deviations between the attachments on the models and the mouth</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Malocclusion</condition>
  <arm_group>
    <arm_group_label>Silicone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Indirect bonding performed with the silicone trays</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vacuum formed</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Indirect bonding performed with the vacuum formed trays</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Indirect bonding</intervention_name>
    <description>Indirect bonding is the technique where orthodontic appliances are first placed on a model of the patient and then transferred to the patient using some kinf of trays</description>
    <arm_group_label>Silicone</arm_group_label>
    <arm_group_label>Vacuum formed</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The presence of indication for both arches to be bonded in the same appointment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of restorations, hypoplasia or decalcification on vestibular tooth surfaces&#xD;
&#xD;
          -  Abnormal crown morphology&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>20 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cihan Aydoğan</name>
      <address>
        <city>Van</city>
        <zip>65080</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 22, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>November 22, 2018</last_update_submitted>
  <last_update_submitted_qc>November 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yuzuncu Yıl University</investigator_affiliation>
    <investigator_full_name>Dr. Cihan Aydoğan</investigator_full_name>
    <investigator_title>Assistant prof</investigator_title>
  </responsible_party>
  <keyword>Indirect bonding</keyword>
  <keyword>Accuracy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malocclusion</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03754283
org study id: 03-05.04.2016
nct id: NCT03754283
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to comparatively investigate the performances of two different and
      widely used transfer trays during indirect bonding of the orthodontic braces.
The aim of the study is to compare the accuracy of orthodontic bracket and tube transfer
      between double layer silicone and double layer vacuum formed trays. The sample included 368
      attachments bonded in 16 patients. Each patient received one silicone and one vacuum formed
      tray which were randomly allocated to provide 8 trays of each type for the upper and lower
      arches. 3D scan data and local best-fit alignments were used to calculate the translational
      and rotational movements of the orthodontic attachments. Chi-square and Mann-Whitney U tests
      were used to compare transfer accuracy and success between the groups.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 1:1
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Transfer accuracy (composite outcome) in milimetres and degrees. Which is measured on computer software.
time frame: Day 0 - Day 2
description: The positional deviations between the attachments on the models and the mouth
arm group label: Silicone
arm group type: Experimental
description: Indirect bonding performed with the silicone trays
arm group label: Vacuum formed
arm group type: Active Comparator
description: Indirect bonding performed with the vacuum formed trays
intervention type: Device
intervention name: Indirect bonding
description: Indirect bonding is the technique where orthodontic appliances are first placed on a model of the patient and then transferred to the patient using some kinf of trays
arm group label: Silicone
arm group label: Vacuum formed
criteria: 
gender: All
minimum age: 15 Years
maximum age: 20 Years
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Yuzuncu Yıl University
investigator full name: Dr. Cihan Aydoğan
investigator title: Assistant prof
mesh term: Malocclusion
sharing ipd: No