<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/NCT03014388</url>
  </required_header>
  <id_info>
    <org_study_id>CairoU MPM</org_study_id>
    <nct_id>NCT03014388</nct_id>
  </id_info>
  <brief_title>Posterior Maxillary Ridge Augmentation With Sinus Lift Using Mineralized Plasmatic Matrix Versus Autogenous Bone Graft</brief_title>
  <acronym>MPM</acronym>
  <official_title>Posterior Maxillary Ridge Augmentation With Sinus Lift Using Mineralized Plasmatic Matrix Versus Autogenous Bone Graft (A Randomized Clinical Trial Comparative Study)</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>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Using growth factors obtained from patient's venous blood mixed with particulate autogenous&#xD;
      bone the study compares bone gain by implant with gold standards in sinus Lift procedures for&#xD;
      future implant insertion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To study the effectiveness of MPM in ridge augmentation with implant insertion compared with&#xD;
      autogenous bone graft.&#xD;
&#xD;
      -PICO Population(P) : Patients with defective posterior maxillary alveolar ridge.&#xD;
      Intervention (I) :Implant placement and ridge augmentation with MPM. Comparator (C) :&#xD;
      Autogenous bone graft. Outcome (O) : Patient satisfaction - Implant stability.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">October 2017</completion_date>
  <primary_completion_date type="Anticipated">September 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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Satisfaction regarding aesthetic results will be measured using questionnaire.</measure>
    <time_frame>9 months</time_frame>
    <description>outcome will be measure using questionnaire.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stability of dental implants.</measure>
    <time_frame>5 months</time_frame>
    <description>will be measured using OSTELL Device.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Bone Resorption</condition>
  <arm_group>
    <arm_group_label>Autogenous bone graft (Gold Standard).</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with defective posterior maxillary alveolar ridges requiring implant insertion will have Autogenous bone graft (Gold standard) and to be used for bone augmentation with sinus lift.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mineralized Plasmatic Matrix (MPM)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with defective posterior maxillary alveolar ridges requiring implant insertion will receive bone graft using Mineralized plasmatic matrix.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>autogenous bone</intervention_name>
    <description>Autogenous bone graft (gold standard). sinus lift with autogenous bone.</description>
    <arm_group_label>Autogenous bone graft (Gold Standard).</arm_group_label>
    <other_name>Autobone</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mineralized plasmatic matrix</intervention_name>
    <description>By using venoud blood from the patient, together with bone graft, a centrifuge will be used to obtain the top layer after centrifuging blood at 3000 RPM.</description>
    <arm_group_label>Mineralized Plasmatic Matrix (MPM)</arm_group_label>
    <other_name>MPM</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients systemically free.&#xD;
&#xD;
          2. Patients with posterior maxillary defective ridges indicated for sinus lift procedure.&#xD;
&#xD;
          3. Cases with 5 mm bone height or less are included in the study.&#xD;
&#xD;
          4. Age between 18 and 50 years.&#xD;
&#xD;
          5. Both sexes.&#xD;
&#xD;
          6. Patients physically able to tolerate surgical and restorative procedures.&#xD;
&#xD;
          7. Good oral hygiene.&#xD;
&#xD;
          8. Highly motivated patients.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients allergic to local anesthetic agent.&#xD;
&#xD;
          2. Medium and heavy smokers.&#xD;
&#xD;
          3. Pregnant females.&#xD;
&#xD;
          4. Presence of any pathosis in the pre-implant site.&#xD;
&#xD;
          5. Presence of any mucosal disease.&#xD;
&#xD;
          6. History of oral radiotherapy.&#xD;
&#xD;
          7. History of prolonged steroids use.&#xD;
&#xD;
          8. Psychological disorders.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cairo University CBE</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University - Ethics Committee.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>refaat ragab, Master</last_name>
    <phone>01111175536</phone>
    <email>refaat.ragab.rr@gmail.com</email>
  </overall_contact>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>January 5, 2017</last_update_submitted>
  <last_update_submitted_qc>January 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Refaat Ragab Abu Ellill</investigator_full_name>
    <investigator_title>Dentist at menistry of health</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bone Resorption</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Evaluation of the comparative Effectiveness of MPM Augmentation in posterior maxillary ridge defects with Autogenous bone graft.</ipd_description>
  </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/NCT03014388
org study id: CairoU MPM
nct id: NCT03014388
lead sponsor: 
has dmc: No
Using growth factors obtained from patient's venous blood mixed with particulate autogenous
      bone the study compares bone gain by implant with gold standards in sinus Lift procedures for
      future implant insertion.
To study the effectiveness of MPM in ridge augmentation with implant insertion compared with
      autogenous bone graft.

      -PICO Population(P) : Patients with defective posterior maxillary alveolar ridge.
      Intervention (I) :Implant placement and ridge augmentation with MPM. Comparator (C) :
      Autogenous bone graft. Outcome (O) : Patient satisfaction - Implant stability.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Patient Satisfaction regarding aesthetic results will be measured using questionnaire.
time frame: 9 months
description: outcome will be measure using questionnaire.
measure: Stability of dental implants.
time frame: 5 months
description: will be measured using OSTELL Device.
arm group label: Autogenous bone graft (Gold Standard).
arm group type: Experimental
description: Patients with defective posterior maxillary alveolar ridges requiring implant insertion will have Autogenous bone graft (Gold standard) and to be used for bone augmentation with sinus lift.
arm group label: Mineralized Plasmatic Matrix (MPM)
arm group type: Experimental
description: Patients with defective posterior maxillary alveolar ridges requiring implant insertion will receive bone graft using Mineralized plasmatic matrix.
intervention type: Other
intervention name: autogenous bone
description: Autogenous bone graft (gold standard). sinus lift with autogenous bone.
arm group label: Autogenous bone graft (Gold Standard).
other name: Autobone
intervention type: Other
intervention name: Mineralized plasmatic matrix
description: By using venoud blood from the patient, together with bone graft, a centrifuge will be used to obtain the top layer after centrifuging blood at 3000 RPM.
arm group label: Mineralized Plasmatic Matrix (MPM)
other name: MPM
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Cairo University CBE
role: Principal Investigator
affiliation: Cairo University - Ethics Committee.
last name: refaat ragab, Master
phone: 01111175536
email: refaat.ragab.rr@gmail.com
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Refaat Ragab Abu Ellill
investigator title: Dentist at menistry of health
mesh term: Bone Resorption
sharing ipd: No
ipd description: Evaluation of the comparative Effectiveness of MPM Augmentation in posterior maxillary ridge defects with Autogenous bone graft.