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/NCT06020183</url>
    </required_header>
    <id_info>
      <org_study_id>14623</org_study_id>
      <nct_id>NCT06020183</nct_id>
    </id_info>
    <brief_title>Effectiveness of Four Mini-screws Supported Hyrax for Maxillary Expansion in Early Adulthood</brief_title>
    <official_title>Effectiveness of Four Mini-screws Supported Hyrax for Maxillary Expansion in Early Adulthood: A Randomized Control Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cairo University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cairo University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study aims to evaluate the Skeletal and Dento-alveolar expansion in adult patents using&#xD;
        Four Mini-screws Supported Hyrax in compare with untreated control group.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Aim of the study: To evaluate the Effectiveness of Four Mini-screws Supported Hyrax for&#xD;
        Maxillary Expansion in Early Adulthood&#xD;
  &#xD;
        Methodology:&#xD;
  &#xD;
          -  Essential record for orthodontic treatment will be taken.&#xD;
  &#xD;
          -  impression with bands on upper first molars will be taken.&#xD;
  &#xD;
          -  Four eyelets will be soldered to the body of the hyrax appliance (size 10, Dentaurum,&#xD;
             Germany).&#xD;
  &#xD;
          -  CBCT will be taken while patient wearing 1 mm thickness vacuum on the lower arch to&#xD;
             dis-occlude both arches.&#xD;
  &#xD;
          -  Delivery, check the retention and fitness of the appliance.&#xD;
  &#xD;
          -  The appliance will be cemented using band cement(compomer).&#xD;
  &#xD;
          -  Using 3M contra-angle driver, the screws (Tomas screw size 10, Dentaurum, Germany) will&#xD;
             be loaded and inserted.&#xD;
  &#xD;
          -  Activation of the appliance by opening it two turns immediately, followed by two turns&#xD;
             everyday till cross bite correction or appearance of midline diastema.&#xD;
  &#xD;
          -  Closure of the device, and leave the appliance in-situ for five months as a retention.&#xD;
  &#xD;
          -  Post-expansion CBCT will be taken and continue fixed orthodontic treatment.&#xD;
  &#xD;
        Outcome: skeletal and dento-alveolar expansion will be evaluated&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">April 2, 2023</start_date>
    <completion_date type="Anticipated">June 2, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2, 2023</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>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Skeletal maxillary expansion</measure>
      <time_frame>5 months interval between pre and post-expansion</time_frame>
      <description>To compare the amount of skeletal expansion pre and post expansion</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Dento-alaveolar expansion</measure>
      <time_frame>5 months interval between pre and post-expansion</time_frame>
      <description>To compare the amount of Dento-alaveolar expansion pre and post expansion</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">24</enrollment>
    <condition>Transverse Maxillary Deficiency</condition>
    <arm_group>
      <arm_group_label>Hybrid Hyrax</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>these patents will be treated using Four mini-screws supported hyrax</description>
    </arm_group>
    <arm_group>
      <arm_group_label>untreated control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Ethically ,these patents will be treated at the end of the study using the same appliance used for the experimental group</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Hybrid hyrax</intervention_name>
      <description>these patents will be treated using Four mini-screws supported hybrid hyrax</description>
      <arm_group_label>Hybrid Hyrax</arm_group_label>
      <other_name>MARPE(miniscrews-assisted rapid palatal expander)</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Unilateral or bilateral Dental posterior cross-bite&#xD;
  &#xD;
            -  Skeletal Maxillary constriction&#xD;
  &#xD;
            -  Male and female patients.&#xD;
  &#xD;
            -  Chronological age (18-30 years).&#xD;
  &#xD;
            -  Mid-palatal suture maturation (Grade C,D ) according to F Angileri classification&#xD;
  &#xD;
            -  Good oral hygiene.&#xD;
  &#xD;
            -  No craniofacial anomalies or syndromes&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Scissor-bite&#xD;
  &#xD;
            -  Orthodontically-treated&#xD;
  &#xD;
            -  functional cross bite due to premature occlusal contact&#xD;
  &#xD;
            -  patients with a syndrome&#xD;
  &#xD;
            -  cleft patients&#xD;
  &#xD;
            -  Mid-palatal suture maturation(Grade A.B,E) according to F Angileri classification&#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>
    <overall_official>
      <last_name>Elzubair Osman</last_name>
      <role>Principal Investigator</role>
      <affiliation>Master Degree student ,Faculty of Dentistry, Cairo University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Faculty of Dentistry, Cairo university</name>
        <address>
          <city>Cairo</city>
          <state>Giza</state>
          <zip>23646375</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>alzubair osman salih</investigator_full_name>
      <investigator_title>Master Degree student ,Faculty of Dentistry ,Cairo university.</investigator_title>
    </responsible_party>
    <keyword>maxillary expasnion</keyword>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT06020183
  org study id: 14623
  nct id: NCT06020183
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  This study aims to evaluate the Skeletal and Dento-alveolar expansion in adult patents using
        Four Mini-screws Supported Hyrax in compare with untreated control group.
  Aim of the study: To evaluate the Effectiveness of Four Mini-screws Supported Hyrax for
        Maxillary Expansion in Early Adulthood
  
        Methodology:
  
          -  Essential record for orthodontic treatment will be taken.
  
          -  impression with bands on upper first molars will be taken.
  
          -  Four eyelets will be soldered to the body of the hyrax appliance (size 10, Dentaurum,
             Germany).
  
          -  CBCT will be taken while patient wearing 1 mm thickness vacuum on the lower arch to
             dis-occlude both arches.
  
          -  Delivery, check the retention and fitness of the appliance.
  
          -  The appliance will be cemented using band cement(compomer).
  
          -  Using 3M contra-angle driver, the screws (Tomas screw size 10, Dentaurum, Germany) will
             be loaded and inserted.
  
          -  Activation of the appliance by opening it two turns immediately, followed by two turns
             everyday till cross bite correction or appearance of midline diastema.
  
          -  Closure of the device, and leave the appliance in-situ for five months as a retention.
  
          -  Post-expansion CBCT will be taken and continue fixed orthodontic treatment.
  
        Outcome: skeletal and dento-alveolar expansion will be evaluated
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Care Provider, Investigator, Outcomes Assessor)
  measure: Skeletal maxillary expansion
  time frame: 5 months interval between pre and post-expansion
  description: To compare the amount of skeletal expansion pre and post expansion
  measure: Dento-alaveolar expansion
  time frame: 5 months interval between pre and post-expansion
  description: To compare the amount of Dento-alaveolar expansion pre and post expansion
  arm group label: Hybrid Hyrax
  arm group type: Experimental
  description: these patents will be treated using Four mini-screws supported hyrax
  arm group label: untreated control group
  arm group type: No Intervention
  description: Ethically ,these patents will be treated at the end of the study using the same appliance used for the experimental group
  intervention type: Device
  intervention name: Hybrid hyrax
  description: these patents will be treated using Four mini-screws supported hybrid hyrax
  arm group label: Hybrid Hyrax
  other name: MARPE(miniscrews-assisted rapid palatal expander)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 30 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Elzubair Osman
  role: Principal Investigator
  affiliation: Master Degree student ,Faculty of Dentistry, Cairo University
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: alzubair osman salih
  investigator title: Master Degree student ,Faculty of Dentistry ,Cairo university.
  sharing ipd: Undecided