<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/NCT03839303</url>
  </required_header>
  <id_info>
    <org_study_id>18-11-1</org_study_id>
    <nct_id>NCT03839303</nct_id>
  </id_info>
  <brief_title>Comparison Between Mini Implant Supported Appliance and Headgear in Treatment of Maxillary Excess in Growing Patients</brief_title>
  <official_title>Infra-zygomatic Mini Implant Supported Appliance for Distalization and Intrusion of Maxillary Dentition Compared to Headgear in Growing Patients: 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>Yes</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 the study is to compare an Infra-zygomatic Mini implant supported appliance with&#xD;
      headgear in distalization and intrusion of maxillary dentition for treatment of growing&#xD;
      patients with class II malocclusion (maxillary excess)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this randomized trial, 2 groups will be included. The first group will receive an&#xD;
      Infra-zygomatic Mini implant supported appliance. In the second group, the patient will&#xD;
      receive a removable high pull headgear. the follow-up period will be 8 months or till class I&#xD;
      canine or incisors relation is obtained. the assessment will be through a lateral cephalogram&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Anticipated">December 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">November 1, 2019</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>Anteroposterior position changes of upper first molars.</measure>
    <time_frame>8 months</time_frame>
    <description>Measurements on the lateral cephalogram</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anteroposterior position changes of the maxilla</measure>
    <time_frame>8 months</time_frame>
    <description>Measurements on the lateral cephalogram</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Vertical position changes in maxilla</measure>
    <time_frame>8 months</time_frame>
    <description>Measurements on the lateral cephalogram</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vertical position changes of upper first molars</measure>
    <time_frame>8 months</time_frame>
    <description>Measurements on the lateral cephalogram</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Position changes of upper incisors</measure>
    <time_frame>8 months</time_frame>
    <description>Measurements on the lateral cephalogram</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anteroposterior skeletal changes in mandible</measure>
    <time_frame>8 months</time_frame>
    <description>Measurements on the lateral cephalogram</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">26</enrollment>
  <condition>Class II Division 1 Malocclusion</condition>
  <arm_group>
    <arm_group_label>Mini Implant Supported Appliance</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>this group will receive an Infra-zygomatic Mini Implant Supported Appliance after leveling and alignment of the four upper incisors for 8 months or till class I canine or incisors realation is reached with follow up every month</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Headgear</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>this group will receive a high pull headgear appliance attached to a removable acrylic maxillary splint for 8 months or till class I canine or incisors realation is reached with follow up every month</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Infra-zygomatic Mini Implant Supported Appliance</intervention_name>
    <description>leveling and alignment of the four maxillary incisors&#xD;
infra zygomatic mini-implant will be placed bilaterally&#xD;
wire frame work that is designed resembling the inner bow of headgear will be adapted to the upper arch&#xD;
a heavy arch wire engaging the 4 incisors will be attached to the wire frame work&#xD;
orthopedic force will be delivered from the mini-implants to the wire frame work</description>
    <arm_group_label>Mini Implant Supported Appliance</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>high pull head gear</intervention_name>
    <description>acrylic maxillary splint is made with flying tubes&#xD;
high pull head gear is adapted to be inserted in the flying tubes</description>
    <arm_group_label>Headgear</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Growing patients ( cervical vertebrae maturation stage cs2-cs3 )&#xD;
&#xD;
          2. Maxillary excess&#xD;
&#xD;
          3. Minimum overjet 4 mm&#xD;
&#xD;
          4. class II canines or incisors&#xD;
&#xD;
          5. Increased incisal show at rest and on smiling&#xD;
&#xD;
          6. Normal and increased vertical growth pattern&#xD;
&#xD;
          7. No previous orthodontic treatment&#xD;
&#xD;
          8. No congenitally messing teeth except third molars&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Inadequate incisal show&#xD;
&#xD;
          2. Class II with deficient mandible and normal maxilla&#xD;
&#xD;
          3. Patients with any syndrome&#xD;
&#xD;
          4. Patients with horizontal growth pattern&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed Afifi</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ahmed Afifi</last_name>
    <phone>+201007025732</phone>
    <email>Ahmed.Khaled@dentistry.cu.edu.eg</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cairo University</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cairo university</last_name>
      <phone>0223642705</phone>
      <phone_ext>522</phone_ext>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>February 11, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>May 18, 2019</last_update_submitted>
  <last_update_submitted_qc>May 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ahmed Khaled Mohamed Mohamed</investigator_full_name>
    <investigator_title>Resident in orthodontic department of Cairo University</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malocclusion</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03839303
org study id: 18-11-1
nct id: NCT03839303
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to compare an Infra-zygomatic Mini implant supported appliance with
      headgear in distalization and intrusion of maxillary dentition for treatment of growing
      patients with class II malocclusion (maxillary excess)
In this randomized trial, 2 groups will be included. The first group will receive an
      Infra-zygomatic Mini implant supported appliance. In the second group, the patient will
      receive a removable high pull headgear. the follow-up period will be 8 months or till class I
      canine or incisors relation is obtained. the assessment will be through a lateral cephalogram
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Anteroposterior position changes of upper first molars.
time frame: 8 months
description: Measurements on the lateral cephalogram
measure: Anteroposterior position changes of the maxilla
time frame: 8 months
description: Measurements on the lateral cephalogram
measure: Vertical position changes in maxilla
time frame: 8 months
description: Measurements on the lateral cephalogram
measure: Vertical position changes of upper first molars
time frame: 8 months
description: Measurements on the lateral cephalogram
measure: Position changes of upper incisors
time frame: 8 months
description: Measurements on the lateral cephalogram
measure: Anteroposterior skeletal changes in mandible
time frame: 8 months
description: Measurements on the lateral cephalogram
arm group label: Mini Implant Supported Appliance
arm group type: Experimental
description: this group will receive an Infra-zygomatic Mini Implant Supported Appliance after leveling and alignment of the four upper incisors for 8 months or till class I canine or incisors realation is reached with follow up every month
arm group label: Headgear
arm group type: Active Comparator
description: this group will receive a high pull headgear appliance attached to a removable acrylic maxillary splint for 8 months or till class I canine or incisors realation is reached with follow up every month
intervention type: Device
intervention name: Infra-zygomatic Mini Implant Supported Appliance
description: leveling and alignment of the four maxillary incisors
infra zygomatic mini-implant will be placed bilaterally
wire frame work that is designed resembling the inner bow of headgear will be adapted to the upper arch
a heavy arch wire engaging the 4 incisors will be attached to the wire frame work
orthopedic force will be delivered from the mini-implants to the wire frame work
arm group label: Mini Implant Supported Appliance
intervention type: Device
intervention name: high pull head gear
description: acrylic maxillary splint is made with flying tubes
high pull head gear is adapted to be inserted in the flying tubes
arm group label: Headgear
criteria: 
gender: Male
gender based: Yes
minimum age: 7 Years
maximum age: 15 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ahmed Afifi
role: Principal Investigator
affiliation: Cairo University
last name: Ahmed Afifi
phone: +201007025732
email: Ahmed.Khaled@dentistry.cu.edu.eg
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ahmed Khaled Mohamed Mohamed
investigator title: Resident in orthodontic department of Cairo University
mesh term: Malocclusion
sharing ipd: Undecided