<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/NCT03258411</url>
  </required_header>
  <id_info>
    <org_study_id>BBRPE</org_study_id>
    <nct_id>NCT03258411</nct_id>
  </id_info>
  <brief_title>Evaluation Of Different Rapid Orthodontic Expansion Devices</brief_title>
  <official_title>Comparison of The Short Term Effects of Different Palatal Expanders Using CBCT.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King Abdulaziz University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King Abdulaziz University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluating and comparing the short term effects of different palatal expanders on the amount&#xD;
      of palatal expansion and buccal tipping of posterior teeth.&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
      H0: There is no difference in the short term effects between the different palatal expanders.&#xD;
&#xD;
      H1: There is a significant difference in the short term effects between the different palatal&#xD;
      expanders.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 10, 2015</start_date>
  <completion_date type="Actual">April 1, 2019</completion_date>
  <primary_completion_date type="Actual">February 5, 2019</primary_completion_date>
  <phase>Phase 1</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>Amount of skeletal and dental expansion</measure>
    <time_frame>3 months</time_frame>
    <description>These are linear measurements which will be measured in millimetres in the first and the second cone beam computed tomography images and the difference will be calculated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Amount of dental inclination</measure>
    <time_frame>3 months</time_frame>
    <description>These are angular measurements which will be measured in degrees in the first and the second cone beam computed tomography images and the difference will be calculated.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Cross Bite</condition>
  <arm_group>
    <arm_group_label>Haas group (H)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Rapid Expansion of palatal suture device: tooth-tissue supported expander (Haas (H)).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hyrax (Hx)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Rapid Expansion of palatal suture device: tooth anchored expander (Hyrax (Hx)).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Miniscrew-supported (MHx)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Rapid Expansion of palatal suture device: bone anchored expander (Temporary anchorage devices(miniscrew)-supported (MHx))</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Rapid Expansion of palatal suture</intervention_name>
    <arm_group_label>Haas group (H)</arm_group_label>
    <arm_group_label>Hyrax (Hx)</arm_group_label>
    <arm_group_label>Miniscrew-supported (MHx)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Non-syndromic adolescent patients.&#xD;
&#xD;
          -  Patients in need for palatal expansion treatment.&#xD;
&#xD;
          -  Average face height.&#xD;
&#xD;
          -  No previous orthodontic treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Syndromic adolescent patients.&#xD;
&#xD;
          -  Patients not in need for palatal expansion treatment.&#xD;
&#xD;
          -  Non-average face height.&#xD;
&#xD;
          -  Previous orthodontic treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>King Abdulaziz University, Faculty of Dentistry</name>
      <address>
        <city>Jeddah</city>
        <state>Makkah</state>
        <zip>21589</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <reference>
    <citation>Mosleh MI, Kaddah MA, Abd ElSayed FA, ElSayed HS. Comparison of transverse changes during maxillary expansion with 4-point bone-borne and tooth-borne maxillary expanders. Am J Orthod Dentofacial Orthop. 2015 Oct;148(4):599-607. doi: 10.1016/j.ajodo.2015.04.040.</citation>
    <PMID>26432315</PMID>
  </reference>
  <reference>
    <citation>Lagravere MO, Carey J, Heo G, Toogood RW, Major PW. Transverse, vertical, and anteroposterior changes from bone-anchored maxillary expansion vs traditional rapid maxillary expansion: a randomized clinical trial. Am J Orthod Dentofacial Orthop. 2010 Mar;137(3):304.e1-12; discussion 304-5. doi: 10.1016/j.ajodo.2009.09.016.</citation>
    <PMID>20197161</PMID>
  </reference>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>July 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>April 5, 2020</last_update_submitted>
  <last_update_submitted_qc>April 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>King Abdulaziz University</investigator_affiliation>
    <investigator_full_name>Najla Alhamdani</investigator_full_name>
    <investigator_title>Master degree student</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/NCT03258411
org study id: BBRPE
nct id: NCT03258411
lead sponsor: 
has dmc: Yes
Evaluating and comparing the short term effects of different palatal expanders on the amount
      of palatal expansion and buccal tipping of posterior teeth.

      Hypothesis:

      H0: There is no difference in the short term effects between the different palatal expanders.

      H1: There is a significant difference in the short term effects between the different palatal
      expanders.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Amount of skeletal and dental expansion
time frame: 3 months
description: These are linear measurements which will be measured in millimetres in the first and the second cone beam computed tomography images and the difference will be calculated.
measure: Amount of dental inclination
time frame: 3 months
description: These are angular measurements which will be measured in degrees in the first and the second cone beam computed tomography images and the difference will be calculated.
arm group label: Haas group (H)
arm group type: Active Comparator
description: Rapid Expansion of palatal suture device: tooth-tissue supported expander (Haas (H)).
arm group label: Hyrax (Hx)
arm group type: Active Comparator
description: Rapid Expansion of palatal suture device: tooth anchored expander (Hyrax (Hx)).
arm group label: Miniscrew-supported (MHx)
arm group type: Active Comparator
description: Rapid Expansion of palatal suture device: bone anchored expander (Temporary anchorage devices(miniscrew)-supported (MHx))
intervention type: Device
intervention name: Rapid Expansion of palatal suture
arm group label: Haas group (H)
arm group label: Hyrax (Hx)
arm group label: Miniscrew-supported (MHx)
criteria: 
gender: All
minimum age: 10 Years
maximum age: 16 Years
healthy volunteers: No
facility: 
country: Saudi Arabia
citation: Mosleh MI, Kaddah MA, Abd ElSayed FA, ElSayed HS. Comparison of transverse changes during maxillary expansion with 4-point bone-borne and tooth-borne maxillary expanders. Am J Orthod Dentofacial Orthop. 2015 Oct;148(4):599-607. doi: 10.1016/j.ajodo.2015.04.040.
PMID: 26432315
citation: Lagravere MO, Carey J, Heo G, Toogood RW, Major PW. Transverse, vertical, and anteroposterior changes from bone-anchored maxillary expansion vs traditional rapid maxillary expansion: a randomized clinical trial. Am J Orthod Dentofacial Orthop. 2010 Mar;137(3):304.e1-12; discussion 304-5. doi: 10.1016/j.ajodo.2009.09.016.
PMID: 20197161
responsible party type: Principal Investigator
investigator affiliation: King Abdulaziz University
investigator full name: Najla Alhamdani
investigator title: Master degree student
mesh term: Malocclusion
sharing ipd: Undecided