<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/NCT03286569</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00001731</org_study_id>
    <nct_id>NCT03286569</nct_id>
  </id_info>
  <brief_title>Study the Effect of Upper Expansion Appliances on Lower Jaw Forward Projection/Growth</brief_title>
  <official_title>Study the Effect of Upper Expansion Appliances on Lower Jaw Forward Projection/Growth</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alberta, Graduate Orthodontic Program</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alberta, Graduate Orthodontic Program</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Young children with backward positioned lower jaw/chin will be recruited to have an upper jaw&#xD;
      expansion appliance. Previous research showed that the use of similar appliances can lead to&#xD;
      lower jaw forward growth. 60 young children aged 9-11 will be recruited to have either active&#xD;
      or non-active Wilson type upper arch expansion appliance. Patients will have special x-ray&#xD;
      (Cone Beam computed tomography) before and after treatment (after 9 months) of starting the&#xD;
      treatment. After participation, routine orthodontic treatment will be continued.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Previous research showed that the use of upper jaw expansion appliances can lead to lower jaw&#xD;
      forward growth (1). 60 young children aged 9-11 with backward positioned lower jaw/chin will&#xD;
      be recruited to have either active or non-active Wilson type upper arch expansion appliance.&#xD;
      Patients will have special x-ray (Cone Beam computed tomography) before and after treatment&#xD;
      (after 9 months) of starting the treatment. After participation, routine orthodontic&#xD;
      treatment will be continued.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">April 1, 2018</start_date>
  <completion_date type="Anticipated">February 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2020</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Lower jaw size</measure>
    <time_frame>9 months</time_frame>
    <description>Lower jaw size will be evaluated by computed tomography.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lower jaw projection</measure>
    <time_frame>9 months</time_frame>
    <description>Lower jaw projection will be evaluated by computed tomography.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Jaw joint size</measure>
    <time_frame>9 months</time_frame>
    <description>Jaw joint size will be evaluated by CBCT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Base of skull bone size</measure>
    <time_frame>9 months</time_frame>
    <description>Base of skull bone size will be evaluated by CBCT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Base of skull bone position</measure>
    <time_frame>9 months</time_frame>
    <description>Base of skull bone positions will be evaluated by CBCT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Jaw joint position</measure>
    <time_frame>9 months</time_frame>
    <description>Jaw joint will be evaluated by CBCT</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Overbite (Excessive) Horizontal</condition>
  <arm_group>
    <arm_group_label>Active upper Wilson appliance</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Active upper arch Wilson quadhelex appliance</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non active upper expansion appliance</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Non-Active upper arch Wilson quadhelex appliance</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Upper arch Wilson quadhelex appliance</intervention_name>
    <description>Upper arch Wilson quadhelex appliance</description>
    <arm_group_label>Active upper Wilson appliance</arm_group_label>
    <arm_group_label>Non active upper expansion appliance</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Class II skeletal due to lower jaw backward projection&#xD;
&#xD;
          2. Class II malocclusion&#xD;
&#xD;
          3. Early mixed dentition (all first permanent molars erupted, as well as all erupting&#xD;
             upper and lower permanent incisors)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Other orthodontic treatment provided&#xD;
&#xD;
          2. Growth problems (craniofacial syndromes, etc.)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Dr. Tarek El-Bialy, PhD</last_name>
    <phone>780-492-2751</phone>
    <email>telbialy@ualberta.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Rabia Njie, BDS</last_name>
    <phone>780-850-8752</phone>
    <email>rnjie@ualberta.ca</email>
  </overall_contact_backup>
  <results_reference>
    <citation>McNamara JA Jr, Sigler LM, Franchi L, Guest SS, Baccetti T. Changes in occlusal relationships in mixed dentition patients treated with rapid maxillary expansion. A prospective clinical study. Angle Orthod. 2010 Mar;80(2):230-8. doi: 10.2319/040309-192.1.</citation>
    <PMID>19905846</PMID>
  </results_reference>
  <results_reference>
    <citation>Guest SS, McNamara JA Jr, Baccetti T, Franchi L. Improving Class II malocclusion as a side-effect of rapid maxillary expansion: a prospective clinical study. Am J Orthod Dentofacial Orthop. 2010 Nov;138(5):582-91. doi: 10.1016/j.ajodo.2008.12.026.</citation>
    <PMID>21055598</PMID>
  </results_reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>April 12, 2015</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>September 13, 2017</last_update_submitted>
  <last_update_submitted_qc>September 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alberta, Graduate Orthodontic Program</investigator_affiliation>
    <investigator_full_name>Tarek El-Bialy</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overbite</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/NCT03286569
org study id: Pro00001731
nct id: NCT03286569
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Young children with backward positioned lower jaw/chin will be recruited to have an upper jaw
      expansion appliance. Previous research showed that the use of similar appliances can lead to
      lower jaw forward growth. 60 young children aged 9-11 will be recruited to have either active
      or non-active Wilson type upper arch expansion appliance. Patients will have special x-ray
      (Cone Beam computed tomography) before and after treatment (after 9 months) of starting the
      treatment. After participation, routine orthodontic treatment will be continued.
Previous research showed that the use of upper jaw expansion appliances can lead to lower jaw
      forward growth (1). 60 young children aged 9-11 with backward positioned lower jaw/chin will
      be recruited to have either active or non-active Wilson type upper arch expansion appliance.
      Patients will have special x-ray (Cone Beam computed tomography) before and after treatment
      (after 9 months) of starting the treatment. After participation, routine orthodontic
      treatment will be continued.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Lower jaw size
time frame: 9 months
description: Lower jaw size will be evaluated by computed tomography.
measure: Lower jaw projection
time frame: 9 months
description: Lower jaw projection will be evaluated by computed tomography.
measure: Jaw joint size
time frame: 9 months
description: Jaw joint size will be evaluated by CBCT
measure: Base of skull bone size
time frame: 9 months
description: Base of skull bone size will be evaluated by CBCT
measure: Base of skull bone position
time frame: 9 months
description: Base of skull bone positions will be evaluated by CBCT
measure: Jaw joint position
time frame: 9 months
description: Jaw joint will be evaluated by CBCT
arm group label: Active upper Wilson appliance
arm group type: Active Comparator
description: Active upper arch Wilson quadhelex appliance
arm group label: Non active upper expansion appliance
arm group type: Placebo Comparator
description: Non-Active upper arch Wilson quadhelex appliance
intervention type: Device
intervention name: Upper arch Wilson quadhelex appliance
description: Upper arch Wilson quadhelex appliance
arm group label: Active upper Wilson appliance
arm group label: Non active upper expansion appliance
criteria: 
gender: All
minimum age: 9 Years
maximum age: 11 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dr. Tarek El-Bialy, PhD
phone: 780-492-2751
email: telbialy@ualberta.ca
last name: Rabia Njie, BDS
phone: 780-850-8752
email: rnjie@ualberta.ca
citation: McNamara JA Jr, Sigler LM, Franchi L, Guest SS, Baccetti T. Changes in occlusal relationships in mixed dentition patients treated with rapid maxillary expansion. A prospective clinical study. Angle Orthod. 2010 Mar;80(2):230-8. doi: 10.2319/040309-192.1.
PMID: 19905846
citation: Guest SS, McNamara JA Jr, Baccetti T, Franchi L. Improving Class II malocclusion as a side-effect of rapid maxillary expansion: a prospective clinical study. Am J Orthod Dentofacial Orthop. 2010 Nov;138(5):582-91. doi: 10.1016/j.ajodo.2008.12.026.
PMID: 21055598
responsible party type: Principal Investigator
investigator affiliation: University of Alberta, Graduate Orthodontic Program
investigator full name: Tarek El-Bialy
investigator title: Professor
mesh term: Overbite