xml: <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/NCT06015386</url>
    </required_header>
    <id_info>
      <org_study_id>ACB</org_study_id>
      <nct_id>NCT06015386</nct_id>
    </id_info>
    <brief_title>Clear Aligner Versus Removable Inclined Plane in Treatment of Anterior Crossbite</brief_title>
    <official_title>Clear Aligner Versus Removable Inclined Plane in Treatment of Anterior Crossbite</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mansoura University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mansoura 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 study is carried in faculty of dentistry Mansoura university to compare the efficiency&#xD;
        and health quality life improvement between clear aligner and inclined plane in treatment of&#xD;
        anterior crossbite&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        the study *include 24 patient each group include 12 patient where randomly allocated and&#xD;
        intra-oral scanning is done for them followed by software designing ,printing using PETG&#xD;
        sheets of 0.75 in aligner group while in inclined plane the appliance is formed in&#xD;
        conventional way.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 22, 2023</start_date>
    <completion_date type="Anticipated">July 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 30, 2024</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>(OHRQoL (Oral Health-related Quality of Life)</measure>
      <time_frame>4 month</time_frame>
      <description>CPQ8-10 scores at two different points in time.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>cephalometric analysis of data</measure>
      <time_frame>4 month</time_frame>
      <description>compare cephalometric variables between two groups</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>3D model measurements</measure>
      <time_frame>4 month</time_frame>
      <description>compare 3D model measurements variable between 2 group</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">24</enrollment>
    <condition>Anterior Crossbite</condition>
    <arm_group>
      <arm_group_label>inclined plane</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>group treated with inclined plane</description>
    </arm_group>
    <arm_group>
      <arm_group_label>clear aligner</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>group treated with clear aligner</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>inclined plane</intervention_name>
      <description>2 parallel groups one treated with clear aligner and other treated using inclined plane</description>
      <arm_group_label>inclined plane</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>clear aligner</intervention_name>
      <description>2 parallel groups one treated with clear aligner and other treated using inclined plane</description>
      <arm_group_label>clear aligner</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:1. Patients age (7-12) years. 2. anterior crossbite 3. More than one&#xD;
          tooth in a crossbite. 4. Favorable oral hygiene 5. No oral habits 6. ANB within the normal&#xD;
          range i.e. (The crossbite will be diagnosed as functional or dental)&#xD;
  &#xD;
          -&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Systemic conditions that may interfere with the treatment.&#xD;
  &#xD;
            2. Bad habits that might jeopardize the appliance.&#xD;
  &#xD;
            3. Transverse discrepancy.&#xD;
  &#xD;
            4. Previous orthodontic treatment&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>7 Years</minimum_age>
      <maximum_age>12 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>asmaa Mohammed, BDS</last_name>
      <phone>1142820091</phone>
      <phone_ext>002</phone_ext>
      <email>asmaasalah@mans.edu.eg</email>
    </overall_contact>
    <location>
      <facility>
        <name>Faculty of Dentistry</name>
        <address>
          <city>El Mansura</city>
          <zip>35511</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Asmaa Mohammed, BDS</last_name>
        <phone>1142820091</phone>
        <phone_ext>002</phone_ext>
        <email>asmaasalah@mans.edu.eg</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Mansoura University</investigator_affiliation>
      <investigator_full_name>Asmaa Salah</investigator_full_name>
      <investigator_title>teaching assistant</investigator_title>
    </responsible_party>
    <keyword>clear aligner , anterior crossbite , inclined plane</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>
  
  
text: 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/NCT06015386
  org study id: ACB
  nct id: NCT06015386
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  the study is carried in faculty of dentistry Mansoura university to compare the efficiency
        and health quality life improvement between clear aligner and inclined plane in treatment of
        anterior crossbite
  the study *include 24 patient each group include 12 patient where randomly allocated and
        intra-oral scanning is done for them followed by software designing ,printing using PETG
        sheets of 0.75 in aligner group while in inclined plane the appliance is formed in
        conventional way.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: (OHRQoL (Oral Health-related Quality of Life)
  time frame: 4 month
  description: CPQ8-10 scores at two different points in time.
  measure: cephalometric analysis of data
  time frame: 4 month
  description: compare cephalometric variables between two groups
  measure: 3D model measurements
  time frame: 4 month
  description: compare 3D model measurements variable between 2 group
  arm group label: inclined plane
  arm group type: Experimental
  description: group treated with inclined plane
  arm group label: clear aligner
  arm group type: Experimental
  description: group treated with clear aligner
  intervention type: Other
  intervention name: inclined plane
  description: 2 parallel groups one treated with clear aligner and other treated using inclined plane
  arm group label: inclined plane
  intervention type: Other
  intervention name: clear aligner
  description: 2 parallel groups one treated with clear aligner and other treated using inclined plane
  arm group label: clear aligner
  criteria: 
  gender: All
  minimum age: 7 Years
  maximum age: 12 Years
  healthy volunteers: No
  last name: asmaa Mohammed, BDS
  phone: 1142820091
  phone ext: 002
  email: asmaasalah@mans.edu.eg
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Mansoura University
  investigator full name: Asmaa Salah
  investigator title: teaching assistant
  mesh term: Malocclusion
  sharing ipd: No