<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/NCT03264053</url>
  </required_header>
  <id_info>
    <org_study_id>CEBD-CU-2017-08-03</org_study_id>
    <nct_id>NCT03264053</nct_id>
  </id_info>
  <brief_title>Socket Shield Technique Versus Conventional Immediate Implant Placement in Thin Buccofacial Bone</brief_title>
  <official_title>Socket Shield Technique Versus Conventional Immediate Implant Placement in Thin Buccofacial Bone to Evaluate Buccal Bone Resorption: A Randomized Controlled 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>
      Buccal bone is prone to resorb after tooth extraction specially with immediate tooth&#xD;
      implantation which could compromise the esthetics of the patient. socket shield technique&#xD;
      retains the buccal aspect of the extracted root fragment which may help in preventing the&#xD;
      buccal bone from resorbing and prevent esthetics deterioration&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The alveolar ridge resorbs and collapses following tooth removal which continues to be a&#xD;
      major concern for practitioners. Many researchers concluded that buccal aspect of the ridge&#xD;
      is more prone to resorption, as it is primarily supplied by the periodontal tissues and&#xD;
      ligments of the tooth. Therefore, extraction of the hopeless tooth, may be a reason for&#xD;
      buccal cortical plate resorbing at a faster rate than the palatal plate leading to its total&#xD;
      degradation. This may lead to dimensional changes in the human ridge and the aesthetic area&#xD;
      is highly affected by this process. Several techniques in the litreture were proposed to&#xD;
      solve the problem of thin buccal bone resorption with or without immediate implantation in&#xD;
      the aesthetic area. Some of these techniques are the guided bone and soft tissue regenraton&#xD;
      and bone augmentation but proved to be slight aggressive with high morbidity rate. Recently,&#xD;
      several papers were published concerning the socket shield technique explaining how to&#xD;
      maintain the ridge width and height. Socket shield technique that was first introduced in&#xD;
      2010 aids at retaining the buccal fragment of root in place and intact thus placing the&#xD;
      implant behind the lingual aspect of that fragment so that the periodontal ligments and&#xD;
      tissues preserve its vitality and aids in preventing the collapsing of the buccal bone. This&#xD;
      would help in improving aesthetics especially during immediate implant placment in the&#xD;
      anterior maxillary region.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 20, 2017</start_date>
  <completion_date type="Anticipated">December 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">August 20, 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>Buccal bone resorption assesed by cone beam computed tomography as a measuring tool</measure>
    <time_frame>12 months</time_frame>
    <description>Measuring buccal bone loss after the procedure comparing between leaving the buccal portion of the root and extracting the whole root</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">86</enrollment>
  <condition>Crestal Bone Loss</condition>
  <arm_group>
    <arm_group_label>SOCKET SHIELD TECHNIQUE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Socket shield is the surgical removal of the frontal aspect of the badly broken root and retaining the lingual aspect so as to prevent crestal bone loss with insertion of the dental implant behind it</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional immediate implantation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional immediate implantation is the surgical removal of the entire badly broken root</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Socket shield</intervention_name>
    <description>Socket shield is the Removal of the lingual portion of the anterior root thus retaining the lingual portion</description>
    <arm_group_label>SOCKET SHIELD TECHNIQUE</arm_group_label>
    <other_name>Implant stability</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conventional immediate implantation</intervention_name>
    <description>Conventional immediate implantation</description>
    <arm_group_label>Conventional immediate implantation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Humans&#xD;
&#xD;
               -  Esthetic area (anterior and first premolars)&#xD;
&#xD;
               -  Intact labial plate&#xD;
&#xD;
               -  Hopeless tooth indicated for extraction and immediate implant placement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Implantation after trauma&#xD;
&#xD;
               -  Peri-implantits defects&#xD;
&#xD;
               -  Use of barrier membranes(GBR)&#xD;
&#xD;
               -  Socket preservation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Abdullah A Mattar, A.Lecturer</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Abdullah A Mattar, A. Lecturer</last_name>
    <phone>00201010022987</phone>
    <email>dr_abdullah.mattar@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Soha A Moustafa, A. Lecturer</last_name>
    <phone>00201007918910</phone>
    <email>charming_dody@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cairo university</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ahmad el khadem, lecturer</last_name>
      <phone>00201227520298</phone>
      <email>hassan.ahmed@dentistry.cu.edu.eg</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>September 14, 2017</last_update_submitted>
  <last_update_submitted_qc>September 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Abdullah Abdou Mattar</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>socket shield technique</keyword>
  <keyword>crestal bone loss</keyword>
  <keyword>immediate implanation</keyword>
  <!-- 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/NCT03264053
org study id: CEBD-CU-2017-08-03
nct id: NCT03264053
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Buccal bone is prone to resorb after tooth extraction specially with immediate tooth
      implantation which could compromise the esthetics of the patient. socket shield technique
      retains the buccal aspect of the extracted root fragment which may help in preventing the
      buccal bone from resorbing and prevent esthetics deterioration
The alveolar ridge resorbs and collapses following tooth removal which continues to be a
      major concern for practitioners. Many researchers concluded that buccal aspect of the ridge
      is more prone to resorption, as it is primarily supplied by the periodontal tissues and
      ligments of the tooth. Therefore, extraction of the hopeless tooth, may be a reason for
      buccal cortical plate resorbing at a faster rate than the palatal plate leading to its total
      degradation. This may lead to dimensional changes in the human ridge and the aesthetic area
      is highly affected by this process. Several techniques in the litreture were proposed to
      solve the problem of thin buccal bone resorption with or without immediate implantation in
      the aesthetic area. Some of these techniques are the guided bone and soft tissue regenraton
      and bone augmentation but proved to be slight aggressive with high morbidity rate. Recently,
      several papers were published concerning the socket shield technique explaining how to
      maintain the ridge width and height. Socket shield technique that was first introduced in
      2010 aids at retaining the buccal fragment of root in place and intact thus placing the
      implant behind the lingual aspect of that fragment so that the periodontal ligments and
      tissues preserve its vitality and aids in preventing the collapsing of the buccal bone. This
      would help in improving aesthetics especially during immediate implant placment in the
      anterior maxillary region.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Buccal bone resorption assesed by cone beam computed tomography as a measuring tool
time frame: 12 months
description: Measuring buccal bone loss after the procedure comparing between leaving the buccal portion of the root and extracting the whole root
arm group label: SOCKET SHIELD TECHNIQUE
arm group type: Experimental
description: Socket shield is the surgical removal of the frontal aspect of the badly broken root and retaining the lingual aspect so as to prevent crestal bone loss with insertion of the dental implant behind it
arm group label: Conventional immediate implantation
arm group type: Active Comparator
description: Conventional immediate implantation is the surgical removal of the entire badly broken root
intervention type: Device
intervention name: Socket shield
description: Socket shield is the Removal of the lingual portion of the anterior root thus retaining the lingual portion
arm group label: SOCKET SHIELD TECHNIQUE
other name: Implant stability
intervention type: Procedure
intervention name: Conventional immediate implantation
description: Conventional immediate implantation
arm group label: Conventional immediate implantation
criteria: 
gender: All
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Abdullah A Mattar, A.Lecturer
role: Principal Investigator
affiliation: Cairo University
last name: Abdullah A Mattar, A. Lecturer
phone: 00201010022987
email: dr_abdullah.mattar@hotmail.com
last name: Soha A Moustafa, A. Lecturer
phone: 00201007918910
email: charming_dody@hotmail.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Abdullah Abdou Mattar
investigator title: Principal investigator