<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/NCT03772379</url>
  </required_header>
  <id_info>
    <org_study_id>PhD Protocol</org_study_id>
    <nct_id>NCT03772379</nct_id>
  </id_info>
  <brief_title>Evaluation of Rapid Maxillary Expansion Facilitated by Micro-osteoperforation in Adolescent Patients With Skeletal Maxillary Constriction</brief_title>
  <official_title>Evaluation of Rapid Maxillary Expansion Facilitated by Micro-osteoperforation in Adolescent Patients With Skeletal Maxillary Constriction</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 this study is to evaluate and compare the effect of rapid maxillary expansion with&#xD;
      and without microosteoperforation in patients with skeletal maxillary&#xD;
      constriction.Theoretically, the force generated by the activation of the Hyrax expander leads&#xD;
      initially to the compression of the periodontal ligament, bending of the alveolar bone, and&#xD;
      tipping of the anchor teeth. This in turn contributes to the unfavorable changes in the&#xD;
      supporting tissues; such as root resorption, buccal crown tipping, reduction of buccal bone&#xD;
      thickness, marginal bone loss and alveolar bone fenestration and dehiscence. In this trial,&#xD;
      it is assumed that by reducing the cortical bone resistance, using micro-osteoperforation&#xD;
      (MOP), the alveolar bone bending and buccal tipping that usually occur during expansion will&#xD;
      be reduced and thus facilitating the bone expansion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study consists of 2 groups that are divided divided equally and randomly.The first group&#xD;
      will receive a tooth borne Hyrax expander supported on first premolar and first permanent&#xD;
      molar , whereas the second group will receive the same appliance associated with&#xD;
      microosteoperforation(MOP). The MOP will be performed on the buccal segment bilaterally along&#xD;
      the maxilla starting from the distal of the canine till the distal of the first permanent&#xD;
      molar. The assessment will be done using CBCT scans immediately after expansion and 6 months&#xD;
      postretention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 2019</start_date>
  <completion_date type="Anticipated">May 2020</completion_date>
  <primary_completion_date type="Anticipated">February 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dental tipping.</measure>
    <time_frame>an average1 year</time_frame>
    <description>it will be measured in degree on Cone beam computed tomography image using a software</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Alveolar bending</measure>
    <time_frame>an average1 year</time_frame>
    <description>it will be measured in degree on Cone beam computed tomography image using a software</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dental changes(transverse).</measure>
    <time_frame>an average1 year</time_frame>
    <description>it will be measured in mm on Cone beam computed tomography image using a software</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Skeletal changes(transverse, anteroposterior and vertical)</measure>
    <time_frame>an average1 year</time_frame>
    <description>it will be measured in mm on Cone beam computed tomography image using a software</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pattern of expansion</measure>
    <time_frame>an average1 year</time_frame>
    <description>it will be assessed on Cone beam computed tomography image and in mm clinically with boley gauge.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">34</enrollment>
  <condition>Posterior Crossbite</condition>
  <arm_group>
    <arm_group_label>tooth borne hyrax expander group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients of this group will receive a tooth borne hyrax expander anchored to the first premolars and first permanent molars .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>tooth borne hyrax expander with microosteoperforation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients of this group will receive a tooth borne hyrax expander anchored to the first premolars and first permanent molars and microosteoperforation .</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>tooth borne hyrax expander</intervention_name>
    <description>ready made four stainless steel bands will be supported on the first premolars and first permanent molars and to which the palatal expander will be soldered to form the Hyrax,.The appliance will be activated one quarter turn per day untill reaching maximum amount of lateral expansion of the jack screw. the patients will be recalled twice per week to evaluate the progress of treatment.</description>
    <arm_group_label>tooth borne hyrax expander group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>microosteoperforation</intervention_name>
    <description>ready made four stainless steel bands supported on the first premolars and first permanent molars and to which the palatal expander will be soldered to form the Hyrax.No activation will be provided to the hyrax expander before the micro-osteoperforation is performed.&#xD;
Microosteoperforation will applied bilaterally on the buccal surface between the roots of teeth at the level of mucoginival junction, starting from the distal of canine till the distal of the first permanent molar using a small sized surgical bur mounted on a hand piece .</description>
    <arm_group_label>tooth borne hyrax expander with microosteoperforation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female adolescent patients with an age range 11- 14 years.&#xD;
&#xD;
          -  Having apical constricted maxillary arch reflected by posterior cross-bite and&#xD;
             verified through Howe's analysis on the dental study models.&#xD;
&#xD;
          -  Normal vertical growth pattern.&#xD;
&#xD;
          -  Fully erupted maxillary first premolars and first permanent molars.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous orthodontic treatment.&#xD;
&#xD;
          -  Any congenital anomalies, systemic disease, or asymmetries that might have an&#xD;
             influence on tooth movement.&#xD;
&#xD;
          -  Active periodontal affection or severe gingival inflammation.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>December 10, 2018</last_update_submitted>
  <last_update_submitted_qc>December 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Mennatallah Ihab Elsayed</investigator_full_name>
    <investigator_title>researcher assisstant at the national research center</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malocclusion</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/NCT03772379
org study id: PhD Protocol
nct id: NCT03772379
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to evaluate and compare the effect of rapid maxillary expansion with
      and without microosteoperforation in patients with skeletal maxillary
      constriction.Theoretically, the force generated by the activation of the Hyrax expander leads
      initially to the compression of the periodontal ligament, bending of the alveolar bone, and
      tipping of the anchor teeth. This in turn contributes to the unfavorable changes in the
      supporting tissues; such as root resorption, buccal crown tipping, reduction of buccal bone
      thickness, marginal bone loss and alveolar bone fenestration and dehiscence. In this trial,
      it is assumed that by reducing the cortical bone resistance, using micro-osteoperforation
      (MOP), the alveolar bone bending and buccal tipping that usually occur during expansion will
      be reduced and thus facilitating the bone expansion.
The study consists of 2 groups that are divided divided equally and randomly.The first group
      will receive a tooth borne Hyrax expander supported on first premolar and first permanent
      molar , whereas the second group will receive the same appliance associated with
      microosteoperforation(MOP). The MOP will be performed on the buccal segment bilaterally along
      the maxilla starting from the distal of the canine till the distal of the first permanent
      molar. The assessment will be done using CBCT scans immediately after expansion and 6 months
      postretention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Dental tipping.
time frame: an average1 year
description: it will be measured in degree on Cone beam computed tomography image using a software
measure: Alveolar bending
time frame: an average1 year
description: it will be measured in degree on Cone beam computed tomography image using a software
measure: Dental changes(transverse).
time frame: an average1 year
description: it will be measured in mm on Cone beam computed tomography image using a software
measure: Skeletal changes(transverse, anteroposterior and vertical)
time frame: an average1 year
description: it will be measured in mm on Cone beam computed tomography image using a software
measure: Pattern of expansion
time frame: an average1 year
description: it will be assessed on Cone beam computed tomography image and in mm clinically with boley gauge.
arm group label: tooth borne hyrax expander group
arm group type: Experimental
description: patients of this group will receive a tooth borne hyrax expander anchored to the first premolars and first permanent molars .
arm group label: tooth borne hyrax expander with microosteoperforation
arm group type: Experimental
description: patients of this group will receive a tooth borne hyrax expander anchored to the first premolars and first permanent molars and microosteoperforation .
intervention type: Device
intervention name: tooth borne hyrax expander
description: ready made four stainless steel bands will be supported on the first premolars and first permanent molars and to which the palatal expander will be soldered to form the Hyrax,.The appliance will be activated one quarter turn per day untill reaching maximum amount of lateral expansion of the jack screw. the patients will be recalled twice per week to evaluate the progress of treatment.
arm group label: tooth borne hyrax expander group
intervention type: Procedure
intervention name: microosteoperforation
description: ready made four stainless steel bands supported on the first premolars and first permanent molars and to which the palatal expander will be soldered to form the Hyrax.No activation will be provided to the hyrax expander before the micro-osteoperforation is performed.
Microosteoperforation will applied bilaterally on the buccal surface between the roots of teeth at the level of mucoginival junction, starting from the distal of canine till the distal of the first permanent molar using a small sized surgical bur mounted on a hand piece .
arm group label: tooth borne hyrax expander with microosteoperforation
criteria: 
gender: Female
minimum age: 11 Years
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Mennatallah Ihab Elsayed
investigator title: researcher assisstant at the national research center
mesh term: Malocclusion