<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/NCT03008538</url>
  </required_header>
  <id_info>
    <org_study_id>CairoSPR-Aut</org_study_id>
    <nct_id>NCT03008538</nct_id>
  </id_info>
  <brief_title>Socket Preservation Using Autogenous Bone Graft Versus MPM</brief_title>
  <official_title>Dental Implant Placement in Extraction Socket of Mandibular Anterior and Premolar Areas Treated With Mineralized Plasmatic Matrix Versus Autogenous Bone Graft</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Studying the comparative effectiveness of socket preservation using autogenous bone graft&#xD;
      versus MPM for implant insertion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To assess bone quality, stability of implants placed in fresh extraction sockets of&#xD;
      mandibular anterior and premorals augmented by MPM (Mineralized Plasmatic Matrix) versus&#xD;
      autogenous bone graft (gold standard), at different follow-up periods (0, 3, 6, 9 months).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>September 2016</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">September 2017</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Patient Satisfaction regarding function, to be measured using patient questionnaire.</measure>
    <time_frame>3 Months.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparative histomorphometric analysis, to be measured using a digital software called (leica QWin 500) and unit of measurements are to be (Pixels).</measure>
    <time_frame>3 Months.</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Bone Graft; Complications</condition>
  <arm_group>
    <arm_group_label>Mineralized Plasmatic Matrix</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MPM(Mineralized plasmatic matrix) insertion in extraction sockets for socket preservation for later implant placement and histomorphometric analysis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Autogenous Bone Graft (Gold Standards).</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Socket preservation using Autogenous bone graft for later implant placement and histomorphometric analysis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MPM(Mineralized plasmatic matrix).</intervention_name>
    <description>Preparation of sticky bone graft by addition of growth factors obtained from patient's vebous blood.</description>
    <arm_group_label>Mineralized Plasmatic Matrix</arm_group_label>
    <other_name>Sticky bone graft.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Autogenous Bone Graft</intervention_name>
    <description>Socket preservation using autogenous bone graft for preservation of bone width and height for future implant insertion.</description>
    <arm_group_label>Autogenous Bone Graft (Gold Standards).</arm_group_label>
    <other_name>Gold Standards</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Medically free patients.&#xD;
&#xD;
          2. Patients with mandibular anterior and premolar hopeless teeth indicated for&#xD;
             extraction.&#xD;
&#xD;
          3. Evaluated bone height on X.Ray to be (0-4 mm buccal bone dehiscence).&#xD;
&#xD;
          4. Age between 18 and 40 years.&#xD;
&#xD;
          5. Both sexes.&#xD;
&#xD;
          6. Patients physically able to tolerate surgical and restorative procedures. Good oral&#xD;
             hygiene.&#xD;
&#xD;
          7. Highly motivated patients.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Smokers.&#xD;
&#xD;
          2. Pregnant or lactating females.&#xD;
&#xD;
          3. Presence of any pathosis in the pre-implant site.&#xD;
&#xD;
          4. Presence of Para functional habits.&#xD;
&#xD;
          5. History of oral radiotherapy.&#xD;
&#xD;
          6. History of prolonged steroids use&#xD;
&#xD;
          7. Psychological disorders.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 26, 2016</study_first_submitted>
  <study_first_submitted_qc>December 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>December 30, 2016</last_update_submitted>
  <last_update_submitted_qc>December 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Khaled Jamal Taha Hussien</investigator_full_name>
    <investigator_title>Dentist Msc</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03008538
org study id: CairoSPR-Aut
nct id: NCT03008538
lead sponsor: 
has dmc: Yes
Studying the comparative effectiveness of socket preservation using autogenous bone graft
      versus MPM for implant insertion.
To assess bone quality, stability of implants placed in fresh extraction sockets of
      mandibular anterior and premorals augmented by MPM (Mineralized Plasmatic Matrix) versus
      autogenous bone graft (gold standard), at different follow-up periods (0, 3, 6, 9 months).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Patient Satisfaction regarding function, to be measured using patient questionnaire.
time frame: 3 Months.
measure: Comparative histomorphometric analysis, to be measured using a digital software called (leica QWin 500) and unit of measurements are to be (Pixels).
time frame: 3 Months.
arm group label: Mineralized Plasmatic Matrix
arm group type: Experimental
description: MPM(Mineralized plasmatic matrix) insertion in extraction sockets for socket preservation for later implant placement and histomorphometric analysis.
arm group label: Autogenous Bone Graft (Gold Standards).
arm group type: Active Comparator
description: Socket preservation using Autogenous bone graft for later implant placement and histomorphometric analysis.
intervention type: Other
intervention name: MPM(Mineralized plasmatic matrix).
description: Preparation of sticky bone graft by addition of growth factors obtained from patient's vebous blood.
arm group label: Mineralized Plasmatic Matrix
other name: Sticky bone graft.
intervention type: Other
intervention name: Autogenous Bone Graft
description: Socket preservation using autogenous bone graft for preservation of bone width and height for future implant insertion.
arm group label: Autogenous Bone Graft (Gold Standards).
other name: Gold Standards
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Khaled Jamal Taha Hussien
investigator title: Dentist Msc
sharing ipd: Undecided