<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/NCT03037125</url>
  </required_header>
  <id_info>
    <org_study_id>PERIO 3:7:3</org_study_id>
    <nct_id>NCT03037125</nct_id>
  </id_info>
  <brief_title>The Evaluation Of Bone Width Gain Following Split Crest Technique With Or Without Platelet Rich Fibrin( PRF)</brief_title>
  <official_title>The Evaluation Of Bone Width Gain Following Split Crest Technique With Or Without PRF In Conjunction With Simultaneous Implant Placement In Narrow Alveolar Ridges: A Randomized Controlled Clinical 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Split crest technique is a technique for horizontal bone augmentation used in case of narrow&#xD;
      alveolar ridges as an alternative to the more aggressive techniques such as onlay bone&#xD;
      grafting, guided bone regeneration (GBR) and distraction osteogenesis&#xD;
&#xD;
      The study goal is to evaluate whether if there will be any benefit of using platelet rich&#xD;
      fibrin (PRF) with the split crest technique regarding bone width gain and healing response in&#xD;
      comparison with split crest technique alone, where PRF is considered an autologous, growth&#xD;
      factor containing material which is easy to collect and is of low cost.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 1, 2017</start_date>
  <completion_date type="Anticipated">January 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">August 15, 2017</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>Bone width gain</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">14</enrollment>
  <condition>Ridge Deficiency</condition>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Split crest without PRF</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Split crest with PRF</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Split Crest with PRF</intervention_name>
    <description>Narrow ridges are split to increase the ridge width and immediate implants are placed with PRF closing the gap</description>
    <arm_group_label>Intervention Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Split Crest without PRF</intervention_name>
    <description>Narrow ridges are split to increase the ridge width and immediate implants are placed without grafting</description>
    <arm_group_label>Control Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with at least one missing tooth in the maxillary region&#xD;
&#xD;
          2. All the selected patients have a bucco-palatal width of the edentulous alveolar ridge&#xD;
             from 3.5-5.5mm.&#xD;
&#xD;
          3. All the selected patients have at least 12 mm residual bone height at the edentulous&#xD;
             area&#xD;
&#xD;
          4. The recipient site of the implant should be free from any pathological conditions.&#xD;
&#xD;
          5. No diagnosed bone disease or medication known to affect bone metabolism.&#xD;
&#xD;
          6. Patients who are cooperative, motivated, and hygiene conscious.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients unable to undergo minor oral surgical procedures.&#xD;
&#xD;
          2. Patients with a history of drug abuse or catabolic drugs.&#xD;
&#xD;
          3. Patients with a history of psychiatric disorder.&#xD;
&#xD;
          4. Patients with unrealistic expectations about the esthetic outcome of implant therapy.&#xD;
&#xD;
          5. Patients with insufficient vertical inter-arch space, upon centric occlusion, to&#xD;
             accommodate the available restorative components.&#xD;
&#xD;
          6. Patients in the growth stage with partially erupted teeth.&#xD;
&#xD;
          7. Patients who have any systemic condition that may contraindicate implant therapy.&#xD;
&#xD;
          8. Patients who have any habits that might jeopardize the osseointegration process, such&#xD;
             as smoking and alcoholism.&#xD;
&#xD;
          9. Patients with parafunctional habits that produce overload on the implant, such as&#xD;
             bruxism and clenching.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Youssef E Meshreky, Bachelor</last_name>
    <phone>01006382121</phone>
    <phone_ext>002</phone_ext>
    <email>youssefmeshreky@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Faculty of oral and dental medicine, Cairo university</name>
      <address>
        <city>Cairo Governorate</city>
        <state>Cairo</state>
        <zip>11311</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <contact>
      <last_name>Youssef E Meshreky, Bachelor</last_name>
      <phone>01006382121</phone>
      <phone_ext>002</phone_ext>
      <email>youssefmeshreky@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>January 31, 2017</last_update_submitted>
  <last_update_submitted_qc>January 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Youssef Emad Zaghloul Meshreky</investigator_full_name>
    <investigator_title>Bachelor</investigator_title>
  </responsible_party>
  <!-- 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/NCT03037125
org study id: PERIO 3:7:3
nct id: NCT03037125
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Split crest technique is a technique for horizontal bone augmentation used in case of narrow
      alveolar ridges as an alternative to the more aggressive techniques such as onlay bone
      grafting, guided bone regeneration (GBR) and distraction osteogenesis

      The study goal is to evaluate whether if there will be any benefit of using platelet rich
      fibrin (PRF) with the split crest technique regarding bone width gain and healing response in
      comparison with split crest technique alone, where PRF is considered an autologous, growth
      factor containing material which is easy to collect and is of low cost.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Bone width gain
time frame: 6 months
arm group label: Control Arm
arm group type: Active Comparator
description: Split crest without PRF
arm group label: Intervention Arm
arm group type: Experimental
description: Split crest with PRF
intervention type: Procedure
intervention name: Split Crest with PRF
description: Narrow ridges are split to increase the ridge width and immediate implants are placed with PRF closing the gap
arm group label: Intervention Arm
intervention type: Procedure
intervention name: Split Crest without PRF
description: Narrow ridges are split to increase the ridge width and immediate implants are placed without grafting
arm group label: Control Arm
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Youssef E Meshreky, Bachelor
phone: 01006382121
phone ext: 002
email: youssefmeshreky@gmail.com
facility: 
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Youssef Emad Zaghloul Meshreky
investigator title: Bachelor