<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/NCT03748615</url>
  </required_header>
  <id_info>
    <org_study_id>CairoUimplant master course</org_study_id>
    <nct_id>NCT03748615</nct_id>
  </id_info>
  <brief_title>The Efficiency of Computer Guided Ridge Splitting Using Piezosurgery in Horizontally Deficient Posterior Mandible</brief_title>
  <official_title>The Efficiency of Computer Guided Ridge Splitting Using Piezosurgery in Horizontally Deficient 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>
      The use of implants has significantly increased prosthetic options for edentulous patient.&#xD;
      However, implant placement in the Posterior mandibular region is often hampered significantly&#xD;
      by insufficient atrophic width limitations&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ridge splitting technique causes lateral ridge expansion which creates new implant bed by&#xD;
      longitudinal osteotomy, positioning buccal cortex laterally. The buccal cortex is positioned&#xD;
      laterally to create space between buccal and lingual cortical plates, which is filled by an&#xD;
      endosseous implant with or without any graft material limitations.&#xD;
&#xD;
      Ridge split technique is a very predictable procedure that can achieve substantial gains in&#xD;
      horizontal ridge width of the edentulous posterior mandible without associated morbidity.&#xD;
      This technique allows the clinician to augment the site and do the implant insertion in a&#xD;
      single stage surgery, shortening the healing period drastically.&#xD;
&#xD;
      In the conventional ridge splitting technique, a complete flap is raised to allow adequate&#xD;
      visibility of the bone defect which can result in disturbance of vascular supply and increase&#xD;
      bone resorption rates. In this case report, a new innovative computer guided closed alveolar&#xD;
      ridge splitting flapless technique has been advocated to avoid this disruption.&#xD;
&#xD;
      As Guided implant placement showed a statistically superior accuracy when they are compared&#xD;
      with freehand placement after guided osteotomy Computer guided ridge splitting may have a&#xD;
      superior accuracy than the freehand ridge splitting and may reduce the time of surgery,&#xD;
      healing period and post-operative pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 20, 2018</start_date>
  <completion_date type="Anticipated">November 20, 2019</completion_date>
  <primary_completion_date type="Anticipated">September 20, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time of the procedure ,pain and edema</measure>
    <time_frame>4 month</time_frame>
    <description>the time of the procedure will be measured numerical using visual analogue scan</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Edentulous Patients</condition>
  <condition>Atrophic Posterior Mandible With Insufficient Width</condition>
  <arm_group>
    <arm_group_label>Computer Guided ridge splitting in posterior mandible</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>fabrication of a computer aided surgical guide and performing ridge splitting in posterior mandible using piezosurgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Computer Guided ridge splitting in posterior mandible</intervention_name>
    <description>The computer guided ridge splitting for patients with atrophic posterior mandible and with residual bone width at least 3 to 5mm of residual ridge.&#xD;
The selected patients will be informed of the nature of the research work and informed consent will be signed.&#xD;
Radiographic examination included preoperative digital panoramic radiograph with 1:1 magnification for each patient as a primary survey to obtain an approximation of the available bone height and detect the presence of remaining roots and localized pathosis.&#xD;
Computer surgical guides are fabricated for partially edentulous patients using teeth and tissue as support for the guide.&#xD;
The same surgeon performed all surgeries. All surgical procedures were performed under strict aseptic conditions, all patients received nerve block local anesthesia (Articaine 4% 1:100 000 epinephrine).&#xD;
A crestal incision is made using No. 15 blade extending over the posterior mandible using computer guided surgical stent.&#xD;
no flap elevation .</description>
    <arm_group_label>Computer Guided ridge splitting in posterior mandible</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with edentulous posterior area of the mandible insufficient width less than&#xD;
             5m, 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;
          -  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 neck&#xD;
             neoplasia, or bone augmentation to implant site.&#xD;
&#xD;
          -  Immunodeficiency pathology, bruxism, stress situation (socially or professionally),&#xD;
             emotional instability, and unrealistic aesthetic demands.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>wallaa farahat mohamed, bds</last_name>
    <phone>01069543488</phone>
    <email>loulu_90_ooo@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>mohammed khashaba, phd</last_name>
    <phone>01227754765</phone>
    <email>mohammedkhashaba@hotmail.com</email>
  </overall_contact_backup>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 14, 2018</study_first_submitted>
  <study_first_submitted_qc>November 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>November 18, 2018</last_update_submitted>
  <last_update_submitted_qc>November 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>walla farhat mohamed</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>Mouth, Edentulous</mesh_term>
    <mesh_term>Atrophy</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/NCT03748615
org study id: CairoUimplant master course
nct id: NCT03748615
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The use of implants has significantly increased prosthetic options for edentulous patient.
      However, implant placement in the Posterior mandibular region is often hampered significantly
      by insufficient atrophic width limitations
Ridge splitting technique causes lateral ridge expansion which creates new implant bed by
      longitudinal osteotomy, positioning buccal cortex laterally. The buccal cortex is positioned
      laterally to create space between buccal and lingual cortical plates, which is filled by an
      endosseous implant with or without any graft material limitations.

      Ridge split technique is a very predictable procedure that can achieve substantial gains in
      horizontal ridge width of the edentulous posterior mandible without associated morbidity.
      This technique allows the clinician to augment the site and do the implant insertion in a
      single stage surgery, shortening the healing period drastically.

      In the conventional ridge splitting technique, a complete flap is raised to allow adequate
      visibility of the bone defect which can result in disturbance of vascular supply and increase
      bone resorption rates. In this case report, a new innovative computer guided closed alveolar
      ridge splitting flapless technique has been advocated to avoid this disruption.

      As Guided implant placement showed a statistically superior accuracy when they are compared
      with freehand placement after guided osteotomy Computer guided ridge splitting may have a
      superior accuracy than the freehand ridge splitting and may reduce the time of surgery,
      healing period and post-operative pain.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Time of the procedure ,pain and edema
time frame: 4 month
description: the time of the procedure will be measured numerical using visual analogue scan
arm group label: Computer Guided ridge splitting in posterior mandible
arm group type: Experimental
description: fabrication of a computer aided surgical guide and performing ridge splitting in posterior mandible using piezosurgery
intervention type: Device
intervention name: Computer Guided ridge splitting in posterior mandible
description: The computer guided ridge splitting for patients with atrophic posterior mandible and with residual bone width at least 3 to 5mm of residual ridge.
The selected patients will be informed of the nature of the research work and informed consent will be signed.
Radiographic examination included preoperative digital panoramic radiograph with 1:1 magnification for each patient as a primary survey to obtain an approximation of the available bone height and detect the presence of remaining roots and localized pathosis.
Computer surgical guides are fabricated for partially edentulous patients using teeth and tissue as support for the guide.
The same surgeon performed all surgeries. All surgical procedures were performed under strict aseptic conditions, all patients received nerve block local anesthesia (Articaine 4% 1:100 000 epinephrine).
A crestal incision is made using No. 15 blade extending over the posterior mandible using computer guided surgical stent.
no flap elevation .
arm group label: Computer Guided ridge splitting in posterior mandible
criteria: 
gender: All
minimum age: 25 Years
maximum age: 60 Years
healthy volunteers: No
last name: wallaa farahat mohamed, bds
phone: 01069543488
email: loulu_90_ooo@hotmail.com
last name: mohammed khashaba, phd
phone: 01227754765
email: mohammedkhashaba@hotmail.com
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: walla farhat mohamed
investigator title: Principal Investigator
mesh term: Mouth, Edentulous
mesh term: Atrophy