<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/NCT03007069</url>
  </required_header>
  <id_info>
    <org_study_id>CairoMPM-ABG</org_study_id>
    <nct_id>NCT03007069</nct_id>
  </id_info>
  <brief_title>Preimplant Site Augmentation Using MPM Versus Autogenous Bone Graft</brief_title>
  <official_title>Implant Insertion in Defective Anterior Maxillary Ridge Augmented Using 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>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.&#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-&#xD;
&#xD;
      Population (P): Patients with defective maxillary alveolar ridge requiring implant insertion.&#xD;
&#xD;
      Intervention (I): Ridge augmentation with MPM.&#xD;
&#xD;
      Comparator (C): Autogenous bone graft.&#xD;
&#xD;
      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">December 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 esthetic results , outcome will be measure using questionnaire.</measure>
    <time_frame>5 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stability of dental implants , this will be measured using Ostell device in ISQ units.</measure>
    <time_frame>5 months.</time_frame>
  </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 maxillary alveolar ridges requiring implant insertion will have Autogenous bone graft (Gold standard) and collagen membrane to be used for bone augmentation around exposed threads of inserted dental implants.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MPM Augmentation.</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Mineralized plasmatic matrix (MPM) to be used without collagen membrane to augment the defect in the maxillary bone and cover the exposed threads of the dental implants.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mineralized plasmatic matrix (MPM).</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, for 10 minutes , Which will result if sticky bone graft consistency after mixing.</description>
    <arm_group_label>MPM Augmentation.</arm_group_label>
    <other_name>Sticky bone graft.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Autogenous bone graft (gold standard).</intervention_name>
    <description>Exposed implant threads are to be covered with autogenous bone and collagen membrane.</description>
    <arm_group_label>Autogenous bone graft (Gold Standard).</arm_group_label>
    <other_name>Autobone.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Medically free patients.&#xD;
&#xD;
          2. Evaluated bone height on CBCT to be (0-4 mm buccal bone dehiscence) and width (not&#xD;
             less than 4.5 mm)&#xD;
&#xD;
          3. Patients with Anterior maxillary defective partially edentulous ridge.&#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.&#xD;
&#xD;
          7. Patients with an opposing tooth to the pre-implant site.&#xD;
&#xD;
          8. Good oral hygiene.&#xD;
&#xD;
          9. Highly motivated patients.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients allergic to local anesthetic agent.&#xD;
&#xD;
          2. Pregnant or lactating females.&#xD;
&#xD;
          3. Presence of any pathosis in the pre-implant site.&#xD;
&#xD;
          4. Presence of any mucosal disease.&#xD;
&#xD;
          5. Presence of parafunctional habits.&#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>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 25, 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>Mahmoud Usama Mahmoud El Masry</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 Anterior 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/NCT03007069
org study id: CairoMPM-ABG
nct id: NCT03007069
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.
To study the effectiveness of MPM in ridge augmentation with implant insertion compared with
      autogenous bone graft.

      -PICO-

      Population (P): Patients with defective maxillary alveolar ridge requiring implant insertion.

      Intervention (I): 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 esthetic results , outcome will be measure using questionnaire.
time frame: 5 months
measure: Stability of dental implants , this will be measured using Ostell device in ISQ units.
time frame: 5 months.
arm group label: Autogenous bone graft (Gold Standard).
arm group type: Experimental
description: Patients with defective maxillary alveolar ridges requiring implant insertion will have Autogenous bone graft (Gold standard) and collagen membrane to be used for bone augmentation around exposed threads of inserted dental implants.
arm group label: MPM Augmentation.
arm group type: Active Comparator
description: Mineralized plasmatic matrix (MPM) to be used without collagen membrane to augment the defect in the maxillary bone and cover the exposed threads of the dental implants.
intervention type: Other
intervention name: Mineralized plasmatic matrix (MPM).
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, for 10 minutes , Which will result if sticky bone graft consistency after mixing.
arm group label: MPM Augmentation.
other name: Sticky bone graft.
intervention type: Other
intervention name: Autogenous bone graft (gold standard).
description: Exposed implant threads are to be covered with autogenous bone and collagen membrane.
arm group label: Autogenous bone graft (Gold Standard).
other name: Autobone.
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: Mahmoud Usama Mahmoud El Masry
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 Anterior ridge defects with Autogenous bone graft.