<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/NCT04489654</url>
  </required_header>
  <id_info>
    <org_study_id>interventional</org_study_id>
    <nct_id>NCT04489654</nct_id>
  </id_info>
  <brief_title>Immediate Implant Using Socket Shield Technique With Xenogenic Bone Graft</brief_title>
  <official_title>Evaluation of Immediate Implant Placement With a Modified Socket Shield Technique Using Xenogenic Bone Graft. (a Randomized Controlled Clinical Trial) CLINICAL TRIAL)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alexandria University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alexandria 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>
      Adequate bone volume and a proper aesthetic outcome have become the main focus of interest in&#xD;
      implant dentistry. Alveolar bone resorption is a natural course occurring after tooth&#xD;
      removal. Partial extraction therapy through root preservation has been reported to help in&#xD;
      bone maintenance at the extraction site. In 2010, Hurzeler et al. evaluated a new approach,&#xD;
      at that time, called socket shield technique. Han et al. in 2018 reported the modification of&#xD;
      this technique and leaving the jump gap between the shield and the implant non-grafted. The&#xD;
      importance of bone grafting of the gap between the implant and the labial shield in improving&#xD;
      quality of regenerating bone and prevention of the soft tissue ingrowth has been described.&#xD;
      Thus the hypothesis, of improving the modified socket shield technique by bone grafting could&#xD;
      be tested.&#xD;
&#xD;
      Aim of this study is to evaluate the clinical and radiographic outcomes of using xenogenic&#xD;
      bone graft on outcome of immediate dental implant placement using the modified socket shield&#xD;
      technique.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      16 patients who are admitted to the outpatient clinic of Oral and Maxillofacial Surgery&#xD;
      Department, are divided into two study groups. Control group will receive an immediate&#xD;
      implant with modified socket shield technique. Test group will receive immediate implant with&#xD;
      modified socket shield and deproteinized bovine bone mineral (DBBM) put in the buccal gap.&#xD;
      Outcome measurement is primary and secondary implant stability measurement and CBCT&#xD;
      evaluation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 20, 2019</start_date>
  <completion_date type="Anticipated">October 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 14, 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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>primary and secondary implant stability measurement</measure>
    <time_frame>4 months</time_frame>
    <description>Implant stability measured in units ISQ is concluded through a clinical evaluation using ostell</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bone mineral density</measure>
    <time_frame>6 months</time_frame>
    <description>Bone mineral density is calculated through radiographic evaluation by means of cone beam CT</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">16</enrollment>
  <condition>Immediate Implant</condition>
  <arm_group>
    <arm_group_label>study</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Test group will receive immediate implant with modified socket shield and deproteinized bovine bone mineral (DBBM) OneXeno Graft. ( OneGraft, Germany) put in the buccal gap</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control group will receive an immediate implant with modified socket shield technique but without deproteinized bovine bone mineral (DBBM) OneXeno Graft. ( OneGraft, Germany) in the buccal gap</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>deproteinized bovine bone mineral (DBBM) by OneXeno Graft. ( OneGraft, Germany)</intervention_name>
    <description>deproteinized bovine bone mineral (DBBM) put in the gap between implant and labial shield</description>
    <arm_group_label>study</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age more than 18 years old irrespective of the gender&#xD;
&#xD;
          -  One or more of non-restorable (fractured or decayed) tooth/teeth in the upper&#xD;
             aesthetic regions (incisors, premolars).&#xD;
&#xD;
          -  Free from periodontal diseases.&#xD;
&#xD;
          -  Sufficient bone volume to allow placement of an implant.&#xD;
&#xD;
          -  Ability to read and sign an informed consent form&#xD;
&#xD;
          -  Adequate buccolingual width to allow for a buccal gap presence.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A medical history that contraindicates oral surgical treatment (uncontrolled/untreated&#xD;
             diabetes mellitus, immuno-compromised status, radio/chemotherapy of the oral and&#xD;
             maxillofacial region, treatment with oral and/or intravenous amino-bisphosphonates).&#xD;
&#xD;
          -  Untreated periodontal disease.&#xD;
&#xD;
          -  Vertical root fractures on the buccal aspect.&#xD;
&#xD;
          -  Tooth /teeth with horizontal fractures below bone level.&#xD;
&#xD;
          -  Tooth /teeth with external or internal resorptions.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>lubna f elsharkawy, BDS</last_name>
    <phone>01200508371</phone>
    <email>lubna_elsharkawy@Hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Alexandra university</name>
      <address>
        <city>Alexandria</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>July 19, 2020</study_first_submitted>
  <study_first_submitted_qc>July 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>July 25, 2020</last_update_submitted>
  <last_update_submitted_qc>July 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT04489654
org study id: interventional
nct id: NCT04489654
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Adequate bone volume and a proper aesthetic outcome have become the main focus of interest in
      implant dentistry. Alveolar bone resorption is a natural course occurring after tooth
      removal. Partial extraction therapy through root preservation has been reported to help in
      bone maintenance at the extraction site. In 2010, Hurzeler et al. evaluated a new approach,
      at that time, called socket shield technique. Han et al. in 2018 reported the modification of
      this technique and leaving the jump gap between the shield and the implant non-grafted. The
      importance of bone grafting of the gap between the implant and the labial shield in improving
      quality of regenerating bone and prevention of the soft tissue ingrowth has been described.
      Thus the hypothesis, of improving the modified socket shield technique by bone grafting could
      be tested.

      Aim of this study is to evaluate the clinical and radiographic outcomes of using xenogenic
      bone graft on outcome of immediate dental implant placement using the modified socket shield
      technique.
16 patients who are admitted to the outpatient clinic of Oral and Maxillofacial Surgery
      Department, are divided into two study groups. Control group will receive an immediate
      implant with modified socket shield technique. Test group will receive immediate implant with
      modified socket shield and deproteinized bovine bone mineral (DBBM) put in the buccal gap.
      Outcome measurement is primary and secondary implant stability measurement and CBCT
      evaluation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: primary and secondary implant stability measurement
time frame: 4 months
description: Implant stability measured in units ISQ is concluded through a clinical evaluation using ostell
measure: Bone mineral density
time frame: 6 months
description: Bone mineral density is calculated through radiographic evaluation by means of cone beam CT
arm group label: study
arm group type: Active Comparator
description: Test group will receive immediate implant with modified socket shield and deproteinized bovine bone mineral (DBBM) OneXeno Graft. ( OneGraft, Germany) put in the buccal gap
arm group label: control
arm group type: No Intervention
description: Control group will receive an immediate implant with modified socket shield technique but without deproteinized bovine bone mineral (DBBM) OneXeno Graft. ( OneGraft, Germany) in the buccal gap
intervention type: Biological
intervention name: deproteinized bovine bone mineral (DBBM) by OneXeno Graft. ( OneGraft, Germany)
description: deproteinized bovine bone mineral (DBBM) put in the gap between implant and labial shield
arm group label: study
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: lubna f elsharkawy, BDS
phone: 01200508371
email: lubna_elsharkawy@Hotmail.com
facility: 
status: Recruiting
country: Egypt
responsible party type: Sponsor