<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/NCT04468295</url>
  </required_header>
  <id_info>
    <org_study_id>CEBC-CU-2020-07-09</org_study_id>
    <nct_id>NCT04468295</nct_id>
  </id_info>
  <brief_title>Evaluation of the Rate of Maxillary En-masse Retraction Using 0.018-inch Versus 0.022-inch Slot Brackets in Adults</brief_title>
  <official_title>Evaluation of the Rate of Maxillary En-masse Retraction Using 0.018-inch Versus 0.022-inch Slot Brackets in Adult Patients With Maxillary Dentoalveolar Protrusion: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo 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 study compares the rate of en-masse retraction using 0.018-inch versus 0.022-inch slot&#xD;
      orthodontic bracket systems in adult patients with maxillary dentoalveolar protrusion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  Proper examination of the oral structures is needed to identify caries, fracture or&#xD;
           missing teeth.&#xD;
&#xD;
        -  Full set of records ( study models, lateral cephalometric radiographs, photos) will be&#xD;
           taken for every patient as part of the routine procedure for treatment of patients in&#xD;
           the outpatient clinic of the Orthodontic Department, Cairo University.&#xD;
&#xD;
        -  In intervention group: Bonding of upper and lower arches including 2nd maxillary molars&#xD;
           with bracket prescription Roth 0.018-inch (American Orthodontics).&#xD;
&#xD;
        -  In comparator group: Bonding of upper and lower arches including 2nd maxillary molars&#xD;
           with bracket prescription Roth 0.022-inch (American Orthodontics).&#xD;
&#xD;
        -  Levelling and alignment in both groups with wire sequence: Ni-Ti (0.014,0.016,&#xD;
           0.016×0.022)&#xD;
&#xD;
        -  Steel ligation of maxillary (2nd premolar, 1st molar and 2nd molar) for anchorage.&#xD;
&#xD;
        -  Extraction of maxillary 1st premolars.&#xD;
&#xD;
        -  Impression will be taken, poured in plaster from which digital models will be fabricated&#xD;
           before beginning of en-masse retraction (the baseline model).&#xD;
&#xD;
        -  Lateral cephalometric and periapical radiographs will be taken before starting&#xD;
           retraction.&#xD;
&#xD;
        -  En-masse retraction will be done using 0.017x0.025 TMA T-Loop10 in both groups, the&#xD;
           loops will be reactivated monthly.&#xD;
&#xD;
        -  Alginate impressions will be taken every month, that will be scanned to obtain digital&#xD;
           models to assess the rate of retraction for 6 months.&#xD;
&#xD;
        -  After 6 months, last obtained digital model will be evaluated for assessment of&#xD;
           anchorage loss, and Lateral cephalometric and periapical radiographs will be taken to&#xD;
           assess changes in the anterior teeth inclinations and apical root resorption&#xD;
           respectively.&#xD;
&#xD;
        -  The patients' treatment will be completed as indicated for them.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 28, 2020</start_date>
  <completion_date type="Anticipated">March 28, 2022</completion_date>
  <primary_completion_date type="Anticipated">September 28, 2021</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Retraction Rate</measure>
    <time_frame>6 months</time_frame>
    <description>The rate of en-masse retraction of the anterior teeth</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">22</enrollment>
  <condition>Orthodontic Tooth Movement</condition>
  <arm_group>
    <arm_group_label>0.018-inch slot orthodontic bracket system</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>En-masse retraction using frictionless mechanics with 0.018-inch slot orthodontic bracket system.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>0.022-inch slot orthodontic bracket system</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>En-masse retraction using frictionless mechanics with 0.022-inch slot orthodontic bracket system.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bonding</intervention_name>
    <description>Bonding of upper and lower arches including 2nd maxillary molars with bracket prescription Roth 0.018 inch</description>
    <arm_group_label>0.018-inch slot orthodontic bracket system</arm_group_label>
    <arm_group_label>0.022-inch slot orthodontic bracket system</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Leveling and alignment</intervention_name>
    <description>Leveling and alignment till 0.016 x0.022 Ni Ti</description>
    <arm_group_label>0.018-inch slot orthodontic bracket system</arm_group_label>
    <arm_group_label>0.022-inch slot orthodontic bracket system</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Extraction</intervention_name>
    <description>Extraction of maxillary 1st premolars</description>
    <arm_group_label>0.018-inch slot orthodontic bracket system</arm_group_label>
    <arm_group_label>0.022-inch slot orthodontic bracket system</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Retraction</intervention_name>
    <description>En-masse retraction using 0.017x0.025 TMA T loop</description>
    <arm_group_label>0.018-inch slot orthodontic bracket system</arm_group_label>
    <arm_group_label>0.022-inch slot orthodontic bracket system</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Digital models</intervention_name>
    <description>impression taking and digital scanning</description>
    <arm_group_label>0.018-inch slot orthodontic bracket system</arm_group_label>
    <arm_group_label>0.022-inch slot orthodontic bracket system</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>measurement</intervention_name>
    <description>Assessment the rate of retraction for 6 months</description>
    <arm_group_label>0.018-inch slot orthodontic bracket system</arm_group_label>
    <arm_group_label>0.022-inch slot orthodontic bracket system</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Maxillary dentoalveolar protrusion cases that require upper first premolars&#xD;
             extraction.&#xD;
&#xD;
          -  Full permanent dentition (not necessitating third molars).&#xD;
&#xD;
          -  Good oral hygiene.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients having systemic diseases or on medications that would affect tooth movement.&#xD;
&#xD;
          -  Active periodontal disease or obvious bone loss in maxillary arch.&#xD;
&#xD;
          -  Patients with habits that are detrimental to dental occlusion (thumb sucking, tongue&#xD;
             thrusting).&#xD;
&#xD;
          -  Previous orthodontic treatment.&#xD;
&#xD;
          -  Missing teeth.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>July 10, 2020</last_update_submitted>
  <last_update_submitted_qc>July 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Omar Abdelaziz</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <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/NCT04468295
org study id: CEBC-CU-2020-07-09
nct id: NCT04468295
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study compares the rate of en-masse retraction using 0.018-inch versus 0.022-inch slot
      orthodontic bracket systems in adult patients with maxillary dentoalveolar protrusion.
-  Proper examination of the oral structures is needed to identify caries, fracture or
           missing teeth.

        -  Full set of records ( study models, lateral cephalometric radiographs, photos) will be
           taken for every patient as part of the routine procedure for treatment of patients in
           the outpatient clinic of the Orthodontic Department, Cairo University.

        -  In intervention group: Bonding of upper and lower arches including 2nd maxillary molars
           with bracket prescription Roth 0.018-inch (American Orthodontics).

        -  In comparator group: Bonding of upper and lower arches including 2nd maxillary molars
           with bracket prescription Roth 0.022-inch (American Orthodontics).

        -  Levelling and alignment in both groups with wire sequence: Ni-Ti (0.014,0.016,
           0.016×0.022)

        -  Steel ligation of maxillary (2nd premolar, 1st molar and 2nd molar) for anchorage.

        -  Extraction of maxillary 1st premolars.

        -  Impression will be taken, poured in plaster from which digital models will be fabricated
           before beginning of en-masse retraction (the baseline model).

        -  Lateral cephalometric and periapical radiographs will be taken before starting
           retraction.

        -  En-masse retraction will be done using 0.017x0.025 TMA T-Loop10 in both groups, the
           loops will be reactivated monthly.

        -  Alginate impressions will be taken every month, that will be scanned to obtain digital
           models to assess the rate of retraction for 6 months.

        -  After 6 months, last obtained digital model will be evaluated for assessment of
           anchorage loss, and Lateral cephalometric and periapical radiographs will be taken to
           assess changes in the anterior teeth inclinations and apical root resorption
           respectively.

        -  The patients' treatment will be completed as indicated for them.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Retraction Rate
time frame: 6 months
description: The rate of en-masse retraction of the anterior teeth
arm group label: 0.018-inch slot orthodontic bracket system
arm group type: Experimental
description: En-masse retraction using frictionless mechanics with 0.018-inch slot orthodontic bracket system.
arm group label: 0.022-inch slot orthodontic bracket system
arm group type: Active Comparator
description: En-masse retraction using frictionless mechanics with 0.022-inch slot orthodontic bracket system.
intervention type: Procedure
intervention name: Bonding
description: Bonding of upper and lower arches including 2nd maxillary molars with bracket prescription Roth 0.018 inch
arm group label: 0.018-inch slot orthodontic bracket system
arm group label: 0.022-inch slot orthodontic bracket system
intervention type: Procedure
intervention name: Leveling and alignment
description: Leveling and alignment till 0.016 x0.022 Ni Ti
arm group label: 0.018-inch slot orthodontic bracket system
arm group label: 0.022-inch slot orthodontic bracket system
intervention type: Procedure
intervention name: Extraction
description: Extraction of maxillary 1st premolars
arm group label: 0.018-inch slot orthodontic bracket system
arm group label: 0.022-inch slot orthodontic bracket system
intervention type: Procedure
intervention name: Retraction
description: En-masse retraction using 0.017x0.025 TMA T loop
arm group label: 0.018-inch slot orthodontic bracket system
arm group label: 0.022-inch slot orthodontic bracket system
intervention type: Procedure
intervention name: Digital models
description: impression taking and digital scanning
arm group label: 0.018-inch slot orthodontic bracket system
arm group label: 0.022-inch slot orthodontic bracket system
intervention type: Procedure
intervention name: measurement
description: Assessment the rate of retraction for 6 months
arm group label: 0.018-inch slot orthodontic bracket system
arm group label: 0.022-inch slot orthodontic bracket system
criteria: 
gender: All
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Omar Abdelaziz
investigator title: Principal Investigator
sharing ipd: No