<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/NCT02998632</url>
  </required_header>
  <id_info>
    <org_study_id>CEBC - CU - 2016 - 11 - 165</org_study_id>
    <nct_id>NCT02998632</nct_id>
  </id_info>
  <brief_title>Posterior Mandibular Ridge Augmentation Using Mineralized Plasmatic Matrix Versus Autogenous Bone Graft</brief_title>
  <official_title>The Effect of Posterior Mandibular Ridge Augmentation Using Mineralized Plasmatic Matrix Versus Autogenous Bone Graft on Implant Body Stability: 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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      -  Patients will be diagnosed to determine whether they are eligible for the inclusion&#xD;
           criteria of this study or not. Patients who are eligible will start their surgical&#xD;
           treatment in the next visit after radiographic and surgical site evaluation.&#xD;
&#xD;
        -  On the day of surgery, each patient will be assigned to either intervention or control&#xD;
           group, the patients will receive inferior alveolar nerve block and long buccal nerve&#xD;
           anesthesia. Future implant site will be planned, an incision will be made and flap will&#xD;
           be reflected along the defective ridge.&#xD;
&#xD;
        -  Implant fixture/s will be inserted in the previously planned site. Uncovered fixture&#xD;
           threads and bone defect will be covered by MPM or autogenous bone graft.&#xD;
&#xD;
        -  In the control group, autogenous particulate bone graft will be used for vertical&#xD;
           augmentation and covered with titanium reinforced membrane. In the intervention group,&#xD;
           MPM (Mineralized plasmatic matrix) will be used.&#xD;
&#xD;
        -  Edges will be approximated, Sutures will be placed.&#xD;
&#xD;
        -  Osstell instrument will be used to measure and record fixture primary stability in ISQ&#xD;
           units.&#xD;
&#xD;
        -  Patients will be referred to the fixed prosthodontics department for placement of the&#xD;
           crowns after ensuring success of osseointegration and implant stability (after 4&#xD;
           months).&#xD;
&#xD;
        -  Patients will evaluate their overall satisfaction after fitting the final prosthesis&#xD;
           using a questionnaire at 9 months.&#xD;
&#xD;
        -  After 9 months, CBCT will be performed to evaluate augmented bone height to be compared&#xD;
           with the bone height previously recorded in CBCT.&#xD;
&#xD;
        -  Osstell instrument will be used to evaluate the implant stability ratio in ISQ unit to&#xD;
           be compared to the ratio recorded before.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the study group:&#xD;
&#xD;
        -  Full medical and dental history will be obtained from all the patients participating in&#xD;
           this study (figure 2).&#xD;
&#xD;
        -  Thorough clinical and radiographic examination for the ridge area to be treated will be&#xD;
           done.&#xD;
&#xD;
        -  Future implant site will be planned.&#xD;
&#xD;
        -  Each patient will be asked to evaluate their overall satisfaction using a questionnaire&#xD;
           before any intervention.&#xD;
&#xD;
        -  Patients will receive 2 gm of amoxicillin 1 hour before surgery. They will be instructed&#xD;
           to wash their mouths with a 0.12% chlorhexidine solution for 30 seconds immediately&#xD;
           before surgery.&#xD;
&#xD;
        -  The patient will receive inferior alveolar nerve block and long buccal nerve anesthesia&#xD;
           using articane HCl 4% with 1:100,000 adrenaline local anesthetic solution using&#xD;
           aspirating syringe and 27-gauge needle.&#xD;
&#xD;
        -  After confirming the success of profound local anaesthesia, an incision will be made and&#xD;
           flap will be reflected along the ridge of the previously planned intraoral donor site to&#xD;
           completely expose bone.&#xD;
&#xD;
        -  Autogenous bone graft will be obtained and will be grinded according to the dimensions&#xD;
           of the present defect.&#xD;
&#xD;
        -  MPM (Mineralized plasmatic matrix) will be prepared:&#xD;
&#xD;
      Tubes of 9 ml of venous blood will be taken from the patient and will be placed in a&#xD;
      centrifuge at 2500 rpm / min for 5 min.&#xD;
&#xD;
      At the end of the centrifugation, the blood in the tube will be separated into two&#xD;
      compartments one yellow and one red.&#xD;
&#xD;
      The yellow part will be withdrawn with a syringe to be mixed with the grinded autogenous bone&#xD;
      previously obtained from intra oral site.&#xD;
&#xD;
      Components will be mixed using a probe until the formation of a single homogeneous component,&#xD;
      called the MPM (Mineralized Plasmatic Matrix).&#xD;
&#xD;
        -  The graft site receiver will be prepared by perforating the lateral cortical bone to&#xD;
           improve the vascularization and facilitate cell migration.&#xD;
&#xD;
        -  Implant fixture/s will be inserted in the previously planned site.&#xD;
&#xD;
        -  Uncovered fixture threads and bone defect will be covered by MPM.&#xD;
&#xD;
        -  Osstell instrument will be used to measure and record fixture primary stability in ISQ&#xD;
           units precisely and objectively 48.&#xD;
&#xD;
        -  Edges will be approximated, Sutures will be placed.&#xD;
&#xD;
        -  Sutures will be removed 7 days later.&#xD;
&#xD;
        -  Immediate postoperative CBCT will be performed.&#xD;
&#xD;
        -  Antibiotic (combination of 500mg amoxicillin and 125mg clavulanic acid) and analgesic&#xD;
           and anti-inflammatory (Ibuprofen 600mg) will be prescribed after the surgical procedure&#xD;
           to be administrated by the patients.&#xD;
&#xD;
        -  Patients will be referred to the fixed prosthodontics department for placement of the&#xD;
           crowns after ensuring success of osseointegration and implant stability (after 4&#xD;
           months).&#xD;
&#xD;
      In the control group:&#xD;
&#xD;
        -  The Same previously mentioned procedure will be performed, But here gold standards are&#xD;
           to be performed (Autogenous particulate bone graft used for vertical augmentation will&#xD;
           be covered with titanium reinforced membrane).&#xD;
&#xD;
        -  Osstell tool will be used to measure and record fixture primary stability in ISQ units.&#xD;
&#xD;
        -  Suturing will be performed.&#xD;
&#xD;
        -  Then Immediate Post operative CBCT will be performed.&#xD;
&#xD;
        -  Antibiotic (combination of 500mg amoxicillin and 125mg clavulanic acid) and analgesic&#xD;
           and anti-inflammatory (Ibuprofen 600mg) will be prescribed after the surgical procedure&#xD;
           to be administrated by the patients.&#xD;
&#xD;
        -  Patients will be referred to the fixed prosthodontics department for placement of the&#xD;
           crowns after ensuring success of osseointegration and implant stability (after 4&#xD;
           months).&#xD;
&#xD;
      Postoperative follow up in both groups:&#xD;
&#xD;
        -  After 4 months, Osstell instrument will be used to evaluate the implant stability ratio&#xD;
           in ISQ unit to be compared to the ratio recorded before.&#xD;
&#xD;
        -  After 9 months, Patients will evaluate their overall satisfaction after fitting the&#xD;
           final prosthesis using a questionnaire to be answered by YES or NO.&#xD;
&#xD;
        -  -After 9 months, CBCT will be performed to evaluate augmented bone height to be compared&#xD;
           with the bone height previously recorded in CBCT.&#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">December 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>Implant body stability in ISQ unit</measure>
    <time_frame>Change from baseline implant body stability at 4 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bone height in Cone beam CT</measure>
    <time_frame>Change from baseline bone height at 9 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Patient satisfaction using questionnare</measure>
    <time_frame>9 months</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Bone Augmentation</condition>
  <arm_group>
    <arm_group_label>Interventional</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive 2 gm of amoxicillin 1 hour before surgery. Mouthwash 0.12% chlorhexidine solution for 30 seconds immediately before surgery.&#xD;
Inferior alveolar nerve block and long buccal nerve anesthesia using articane HCl 4% with 1:100,000 adrenaline local anesthetic solution.&#xD;
Flap will be reflected in intraoral donor site to completely expose bone. Autogenous bone graft will be obtained and will be ground. MPM (Mineralized plasmatic matrix) will be prepared. Implant fixture/s will be inserted. Uncovered fixture threads and bone defect will be covered by MPM. Osstell will be used to measure fixture primary stability in ISQ units. Sutures will be placed. Sutures will be removed 7 days later. Immediate postoperative CBCT will be performed. Antibiotic (combination of 500mg amoxicillin and 125mg clavulanic acid) and analgesic and anti-inflammatory (Ibuprofen 600mg) will be prescribed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparator</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive 2 gm of amoxicillin 1 hour before surgery. Mouthwash 0.12% chlorhexidine solution for 30 seconds immediately before surgery.&#xD;
The patient will receive inferior alveolar nerve block and long buccal nerve anesthesia using articane HCl 4% with 1:100,000 adrenaline local anesthetic solution Flap will be reflected in intraoral donor site to completely expose bone. Autogenous bone graft will be obtained and will be ground. Implant fixture/s will be inserted. Uncovered fixture threads and bone defect will be covered by autogenous bone graft and covered by titanium membrane.&#xD;
Osstell instrument will be used to measure and record fixture primary stability in ISQ units.&#xD;
Sutures will be placed. Sutures will be removed 7 days later. Immediate postoperative CBCT will be performed. Antibiotic (combination of 500mg amoxicillin and 125mg clavulanic acid) and analgesic and anti-inflammatory (Ibuprofen 600mg) will be prescribed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Mineralized plasmatic matrix for bone augmentation</intervention_name>
    <description>Vertical bone augmentation of defective posterior mandibular alveolar ridge using MPM (Mineralized Plasmatic Matrix) bone graft.</description>
    <arm_group_label>Interventional</arm_group_label>
    <other_name>Sticky bone graft</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Autogenous bone for bone augmentation</intervention_name>
    <description>Vertical bone augmentation of defective posterior mandibular alveolar ridge using autogenous bone graft (gold standard) covered by titanium membrane.</description>
    <arm_group_label>Comparator</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Medically free patients.&#xD;
&#xD;
          2. Patients with posterior mandibular defective partially edentulous ridge.&#xD;
&#xD;
          3. Evaluated bone height on CBCT to be (0-4 mm buccal bone dehiscence) and width (not&#xD;
             less than 4.5 mm)&#xD;
&#xD;
          4. Patients physically able to tolerate surgical and restorative procedures.&#xD;
&#xD;
          5. Patients with an opposing tooth to the pre-implant site.&#xD;
&#xD;
          6. Good oral hygiene.&#xD;
&#xD;
          7. Highly motivated patients.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients allergic to local anaesthetic agent.&#xD;
&#xD;
          2. smokers.&#xD;
&#xD;
          3. Pregnant or lactating females.&#xD;
&#xD;
          4. Presence of any pathosis in the pre-implant site.&#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>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>December 16, 2016</last_update_submitted>
  <last_update_submitted_qc>December 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 20, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ahmed Abdel-Sattar</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</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/NCT02998632
org study id: CEBC - CU - 2016 - 11 - 165
nct id: NCT02998632
lead sponsor: 
has dmc: Yes
-  Patients will be diagnosed to determine whether they are eligible for the inclusion
           criteria of this study or not. Patients who are eligible will start their surgical
           treatment in the next visit after radiographic and surgical site evaluation.

        -  On the day of surgery, each patient will be assigned to either intervention or control
           group, the patients will receive inferior alveolar nerve block and long buccal nerve
           anesthesia. Future implant site will be planned, an incision will be made and flap will
           be reflected along the defective ridge.

        -  Implant fixture/s will be inserted in the previously planned site. Uncovered fixture
           threads and bone defect will be covered by MPM or autogenous bone graft.

        -  In the control group, autogenous particulate bone graft will be used for vertical
           augmentation and covered with titanium reinforced membrane. In the intervention group,
           MPM (Mineralized plasmatic matrix) will be used.

        -  Edges will be approximated, Sutures will be placed.

        -  Osstell instrument will be used to measure and record fixture primary stability in ISQ
           units.

        -  Patients will be referred to the fixed prosthodontics department for placement of the
           crowns after ensuring success of osseointegration and implant stability (after 4
           months).

        -  Patients will evaluate their overall satisfaction after fitting the final prosthesis
           using a questionnaire at 9 months.

        -  After 9 months, CBCT will be performed to evaluate augmented bone height to be compared
           with the bone height previously recorded in CBCT.

        -  Osstell instrument will be used to evaluate the implant stability ratio in ISQ unit to
           be compared to the ratio recorded before.
In the study group:

        -  Full medical and dental history will be obtained from all the patients participating in
           this study (figure 2).

        -  Thorough clinical and radiographic examination for the ridge area to be treated will be
           done.

        -  Future implant site will be planned.

        -  Each patient will be asked to evaluate their overall satisfaction using a questionnaire
           before any intervention.

        -  Patients will receive 2 gm of amoxicillin 1 hour before surgery. They will be instructed
           to wash their mouths with a 0.12% chlorhexidine solution for 30 seconds immediately
           before surgery.

        -  The patient will receive inferior alveolar nerve block and long buccal nerve anesthesia
           using articane HCl 4% with 1:100,000 adrenaline local anesthetic solution using
           aspirating syringe and 27-gauge needle.

        -  After confirming the success of profound local anaesthesia, an incision will be made and
           flap will be reflected along the ridge of the previously planned intraoral donor site to
           completely expose bone.

        -  Autogenous bone graft will be obtained and will be grinded according to the dimensions
           of the present defect.

        -  MPM (Mineralized plasmatic matrix) will be prepared:

      Tubes of 9 ml of venous blood will be taken from the patient and will be placed in a
      centrifuge at 2500 rpm / min for 5 min.

      At the end of the centrifugation, the blood in the tube will be separated into two
      compartments one yellow and one red.

      The yellow part will be withdrawn with a syringe to be mixed with the grinded autogenous bone
      previously obtained from intra oral site.

      Components will be mixed using a probe until the formation of a single homogeneous component,
      called the MPM (Mineralized Plasmatic Matrix).

        -  The graft site receiver will be prepared by perforating the lateral cortical bone to
           improve the vascularization and facilitate cell migration.

        -  Implant fixture/s will be inserted in the previously planned site.

        -  Uncovered fixture threads and bone defect will be covered by MPM.

        -  Osstell instrument will be used to measure and record fixture primary stability in ISQ
           units precisely and objectively 48.

        -  Edges will be approximated, Sutures will be placed.

        -  Sutures will be removed 7 days later.

        -  Immediate postoperative CBCT will be performed.

        -  Antibiotic (combination of 500mg amoxicillin and 125mg clavulanic acid) and analgesic
           and anti-inflammatory (Ibuprofen 600mg) will be prescribed after the surgical procedure
           to be administrated by the patients.

        -  Patients will be referred to the fixed prosthodontics department for placement of the
           crowns after ensuring success of osseointegration and implant stability (after 4
           months).

      In the control group:

        -  The Same previously mentioned procedure will be performed, But here gold standards are
           to be performed (Autogenous particulate bone graft used for vertical augmentation will
           be covered with titanium reinforced membrane).

        -  Osstell tool will be used to measure and record fixture primary stability in ISQ units.

        -  Suturing will be performed.

        -  Then Immediate Post operative CBCT will be performed.

        -  Antibiotic (combination of 500mg amoxicillin and 125mg clavulanic acid) and analgesic
           and anti-inflammatory (Ibuprofen 600mg) will be prescribed after the surgical procedure
           to be administrated by the patients.

        -  Patients will be referred to the fixed prosthodontics department for placement of the
           crowns after ensuring success of osseointegration and implant stability (after 4
           months).

      Postoperative follow up in both groups:

        -  After 4 months, Osstell instrument will be used to evaluate the implant stability ratio
           in ISQ unit to be compared to the ratio recorded before.

        -  After 9 months, Patients will evaluate their overall satisfaction after fitting the
           final prosthesis using a questionnaire to be answered by YES or NO.

        -  -After 9 months, CBCT will be performed to evaluate augmented bone height to be compared
           with the bone height previously recorded in CBCT.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Implant body stability in ISQ unit
time frame: Change from baseline implant body stability at 4 months
measure: Bone height in Cone beam CT
time frame: Change from baseline bone height at 9 months
measure: Patient satisfaction using questionnare
time frame: 9 months
arm group label: Interventional
arm group type: Experimental
description: Patients will receive 2 gm of amoxicillin 1 hour before surgery. Mouthwash 0.12% chlorhexidine solution for 30 seconds immediately before surgery.
Inferior alveolar nerve block and long buccal nerve anesthesia using articane HCl 4% with 1:100,000 adrenaline local anesthetic solution.
Flap will be reflected in intraoral donor site to completely expose bone. Autogenous bone graft will be obtained and will be ground. MPM (Mineralized plasmatic matrix) will be prepared. Implant fixture/s will be inserted. Uncovered fixture threads and bone defect will be covered by MPM. Osstell will be used to measure fixture primary stability in ISQ units. Sutures will be placed. Sutures will be removed 7 days later. Immediate postoperative CBCT will be performed. Antibiotic (combination of 500mg amoxicillin and 125mg clavulanic acid) and analgesic and anti-inflammatory (Ibuprofen 600mg) will be prescribed.
arm group label: Comparator
arm group type: Active Comparator
description: Patients will receive 2 gm of amoxicillin 1 hour before surgery. Mouthwash 0.12% chlorhexidine solution for 30 seconds immediately before surgery.
The patient will receive inferior alveolar nerve block and long buccal nerve anesthesia using articane HCl 4% with 1:100,000 adrenaline local anesthetic solution Flap will be reflected in intraoral donor site to completely expose bone. Autogenous bone graft will be obtained and will be ground. Implant fixture/s will be inserted. Uncovered fixture threads and bone defect will be covered by autogenous bone graft and covered by titanium membrane.
Osstell instrument will be used to measure and record fixture primary stability in ISQ units.
Sutures will be placed. Sutures will be removed 7 days later. Immediate postoperative CBCT will be performed. Antibiotic (combination of 500mg amoxicillin and 125mg clavulanic acid) and analgesic and anti-inflammatory (Ibuprofen 600mg) will be prescribed.
intervention type: Procedure
intervention name: Mineralized plasmatic matrix for bone augmentation
description: Vertical bone augmentation of defective posterior mandibular alveolar ridge using MPM (Mineralized Plasmatic Matrix) bone graft.
arm group label: Interventional
other name: Sticky bone graft
intervention type: Procedure
intervention name: Autogenous bone for bone augmentation
description: Vertical bone augmentation of defective posterior mandibular alveolar ridge using autogenous bone graft (gold standard) covered by titanium membrane.
arm group label: Comparator
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ahmed Abdel-Sattar
investigator title: Principal Investigator
sharing ipd: No