<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/NCT03781518</url>
  </required_header>
  <id_info>
    <org_study_id>290316</org_study_id>
    <nct_id>NCT03781518</nct_id>
  </id_info>
  <brief_title>Mandibular Ridge Splitting Versus Khoury Shell Technique</brief_title>
  <official_title>Mandibular Ridge Splitting With Complete Separation of the Buccal Cortical Plate Versus Khoury Shell Technique for Horizontal Augmentation of Atrophic Posterior Mandible</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>
      Mandibular ridge splitting with complete separation of the buccal cortical plate versus&#xD;
      Khoury shell technique for horizontal augmentation of atrophic posterior mandible&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2018</start_date>
  <completion_date type="Actual">July 1, 2018</completion_date>
  <primary_completion_date type="Actual">July 1, 2018</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Amount of horizontal bone gain (bone width)</measure>
    <time_frame>4 months</time_frame>
    <description>measurement using CBCT</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Soft tissue healing</measure>
    <time_frame>1 months</time_frame>
    <description>Dehiscence or no dehiscence</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Horizontal Augmentation of Atrophic Posterior Mandible</condition>
  <arm_group>
    <arm_group_label>ridge splitting</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mandibular ridge splitting with complete separation of the buccal cortical plate for horizontal augmentation of atrophic mandible and splinting with screws</description>
  </arm_group>
  <arm_group>
    <arm_group_label>khoury shell technique</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>bone block is taken from the ramus to augment deficient posterior mandible and splinting with screws</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ridge splitting in group and khoury shell technique in the other group</intervention_name>
    <description>Mandibular ridge splitting with complete separation of the buccal cortical plate for horizontal augmentation of atrophic posterior mandible in one group and the other group will receive khoury shell technique by taking bone block from the ramus</description>
    <arm_group_label>khoury shell technique</arm_group_label>
    <arm_group_label>ridge splitting</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with atrophic mandible with residual bone width 3 to 4 mm.&#xD;
&#xD;
          -  Both sexes.&#xD;
&#xD;
          -  No intraoral soft and hard tissue pathology&#xD;
&#xD;
          -  No systemic condition that contraindicate implant placement.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Any pathology in the posterior mandible.&#xD;
&#xD;
               -  Heavy smokers more than 20 cigarettes per day.&#xD;
&#xD;
               -  Patients with systemic disease that may affect normal healing.&#xD;
&#xD;
               -  Psychiatric problems&#xD;
&#xD;
               -  Disorders to implant are related to history of radiation therapy to the head and&#xD;
                  neck neoplasia, or bone augmentation to implant site.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cairo University</name>
      <address>
        <city>Cairo</city>
        <zip>12611</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 1, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>December 18, 2018</last_update_submitted>
  <last_update_submitted_qc>December 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Omnia El- Atawy</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrophy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03781518
org study id: 290316
nct id: NCT03781518
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Mandibular ridge splitting with complete separation of the buccal cortical plate versus
      Khoury shell technique for horizontal augmentation of atrophic posterior mandible
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Amount of horizontal bone gain (bone width)
time frame: 4 months
description: measurement using CBCT
measure: Soft tissue healing
time frame: 1 months
description: Dehiscence or no dehiscence
arm group label: ridge splitting
arm group type: Experimental
description: Mandibular ridge splitting with complete separation of the buccal cortical plate for horizontal augmentation of atrophic mandible and splinting with screws
arm group label: khoury shell technique
arm group type: Active Comparator
description: bone block is taken from the ramus to augment deficient posterior mandible and splinting with screws
intervention type: Procedure
intervention name: ridge splitting in group and khoury shell technique in the other group
description: Mandibular ridge splitting with complete separation of the buccal cortical plate for horizontal augmentation of atrophic posterior mandible in one group and the other group will receive khoury shell technique by taking bone block from the ramus
arm group label: khoury shell technique
arm group label: ridge splitting
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Omnia El- Atawy
investigator title: Principal Investigator
mesh term: Atrophy
sharing ipd: Yes