<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/NCT03231137</url>
  </required_header>
  <id_info>
    <org_study_id>ASU-OMP-2012-9</org_study_id>
    <nct_id>NCT03231137</nct_id>
  </id_info>
  <brief_title>Socket Augmentation Using Platelet Concentrates, Atorvastatin Gel or Combination</brief_title>
  <official_title>Socket Augmentation Using Different Platelet Concentrates, Atorvastatin Gel or Combination (Clinical and Histomorphometric Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study was conducted to compare post-extraction augmented sockets using Atorvastatin&#xD;
      loaded in Plasma rich in growth factors derived fibrin scaffold (PRGF/ATV) or direct&#xD;
      application of Atorvastatin (ATV) gel or platelet rich fibrin (PRF) or (PRGF) and&#xD;
      spontaneously healed socket (Control) both clinically and by histomorphometric analysis of&#xD;
      formed bone quality.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ridge preservation therapies have been proposed with the aim of maintaining the hard and soft&#xD;
      tissue dimensions of the alveolar ridge that are partially lost after tooth extraction as&#xD;
      part of the natural physiological healing process. There are many techniques in the&#xD;
      literature used for socket preservation as bone grafts, barrier membranes, immediate implant&#xD;
      and socket shield. Many other techniques also are used such as bone and tissue healing&#xD;
      promoting molecules like recombinant human bone morphogenetic protein-2 (rhBMP-2). However&#xD;
      Autologous blood preparations like platelet-rich fibrin (PRF), and platelet rich in growth&#xD;
      factors (PRGF) have been also introduced for socket preservation. Moreover, Statins the&#xD;
      widely used group of cholesterol lowering drugs which also increase normal bone formation by&#xD;
      promoting osteoblast proliferation and differentiation and protecting the from apoptosis. In&#xD;
      addition, they reduce osteoclastogenesis by inhibiting osteoclastic differentiation. Statins&#xD;
      increase BMP-2 gene expression and subsequently promote bone formation. in the emerging area&#xD;
      of growth factors, there is no high-quality evidence to either support or refuse their use.&#xD;
&#xD;
      This study hypothesized that use of PRGF fibrin scaffold in socket preservation owing to its&#xD;
      biocompatibility, ease of use, stimulation of production of growth factors and its effect on&#xD;
      the already differentiated osteoblasts, when combined with statin with its effect on&#xD;
      progenitor stem-cells could stimulate the differentiation of stem cells to osteoblasts,&#xD;
      prevent bone resorption and stimulate bone formation at the extraction socket.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 16, 2012</start_date>
  <completion_date type="Actual">July 10, 2017</completion_date>
  <primary_completion_date type="Actual">March 12, 2017</primary_completion_date>
  <phase>Phase 4</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Relative ridge height</measure>
    <time_frame>baseline (immediately after extraction) - After 2 months</time_frame>
    <description>(Measured from stent reference point to the crest of the buccal or palatal plate of bone)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ridge width</measure>
    <time_frame>baseline (immediately after extraction) - After 2 months</time_frame>
    <description>(Measured from the buccal to palatal plate of bone using bone caliper)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Collagen surface area</measure>
    <time_frame>after 2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average tabecular size</measure>
    <time_frame>after 2 months</time_frame>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Alveolar Socket Preservations</condition>
  <arm_group>
    <arm_group_label>PRGF/ATV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Included 10 patients undergoing single tooth extraction and platelet rich in growth factors fibrin scaffold loaded with Atorvastatin powder (PRGF/ATV) were placed to fill the extraction socket.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ATV gel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Included 10 patients undergoing single tooth extraction and Atorvastatin gel were placed to fill the extraction socket.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PRF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Included 10 patients undergoing single tooth extraction and platelet rich fibrin (PRF) were placed to fill the extraction socket.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PRGF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Included 10 patients undergoing single tooth extraction and plasma rich in growth factors (PRGF) were placed to fill the extraction socket.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Spontaneously healed socket</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>PRGF/ATV</intervention_name>
    <description>Atorvastatin (ATV) loaded on plasma rich in growth factor (PRGF) Derived Fibrin Scaffold</description>
    <arm_group_label>PRGF/ATV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ATV gel</intervention_name>
    <description>Atorvastatin gel</description>
    <arm_group_label>ATV gel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PRF</intervention_name>
    <description>Platelet rich fibrin</description>
    <arm_group_label>PRF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PRGF</intervention_name>
    <description>plasma rich in growth factor</description>
    <arm_group_label>PRGF</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Both genders, aged from 20 to 50 years&#xD;
&#xD;
          -  2. Patients free from any systemic diseases&#xD;
&#xD;
          -  3. Hopeless teeth indicated for extraction (badly decayed tooth, tooth contraindicated&#xD;
             for crown preparation such as tooth with subgingival caries, broken roots,&#xD;
             periodontally affected teeth, remaining roots) in the premolar and first molar area.&#xD;
&#xD;
          -  4. Socket type I: The facial soft tissue and buccal plate of bone are at normal levels&#xD;
             in relation to cement-enamel junction of the pre-extracted tooth and remain intact&#xD;
             postextraction as determined by clinical examination and periapical radiographs&#xD;
&#xD;
          -  5. Patient agreed to sign a written consent after explanation of study nature.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Smokers.&#xD;
&#xD;
          -  2. Pregnant and breast feeding females.&#xD;
&#xD;
          -  3. Previous radiation, chemotherapy, or immunosuppressive treatments.&#xD;
&#xD;
          -  4. Known hypersensitivity to statin drugs.&#xD;
&#xD;
          -  5. Teeth with periapical infections, type II or III sockets or with dehiscence or&#xD;
             fenestrations&#xD;
&#xD;
          -  6. Vulnerable groups such as (Prisoners and handicapped or mentally disabled)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>July 25, 2017</last_update_submitted>
  <last_update_submitted_qc>July 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Ola Mohamed Ezzatt</investigator_full_name>
    <investigator_title>Lecturer Dr.</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/NCT03231137
org study id: ASU-OMP-2012-9
nct id: NCT03231137
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study was conducted to compare post-extraction augmented sockets using Atorvastatin
      loaded in Plasma rich in growth factors derived fibrin scaffold (PRGF/ATV) or direct
      application of Atorvastatin (ATV) gel or platelet rich fibrin (PRF) or (PRGF) and
      spontaneously healed socket (Control) both clinically and by histomorphometric analysis of
      formed bone quality.
Ridge preservation therapies have been proposed with the aim of maintaining the hard and soft
      tissue dimensions of the alveolar ridge that are partially lost after tooth extraction as
      part of the natural physiological healing process. There are many techniques in the
      literature used for socket preservation as bone grafts, barrier membranes, immediate implant
      and socket shield. Many other techniques also are used such as bone and tissue healing
      promoting molecules like recombinant human bone morphogenetic protein-2 (rhBMP-2). However
      Autologous blood preparations like platelet-rich fibrin (PRF), and platelet rich in growth
      factors (PRGF) have been also introduced for socket preservation. Moreover, Statins the
      widely used group of cholesterol lowering drugs which also increase normal bone formation by
      promoting osteoblast proliferation and differentiation and protecting the from apoptosis. In
      addition, they reduce osteoclastogenesis by inhibiting osteoclastic differentiation. Statins
      increase BMP-2 gene expression and subsequently promote bone formation. in the emerging area
      of growth factors, there is no high-quality evidence to either support or refuse their use.

      This study hypothesized that use of PRGF fibrin scaffold in socket preservation owing to its
      biocompatibility, ease of use, stimulation of production of growth factors and its effect on
      the already differentiated osteoblasts, when combined with statin with its effect on
      progenitor stem-cells could stimulate the differentiation of stem cells to osteoblasts,
      prevent bone resorption and stimulate bone formation at the extraction socket.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Relative ridge height
time frame: baseline (immediately after extraction) - After 2 months
description: (Measured from stent reference point to the crest of the buccal or palatal plate of bone)
measure: Ridge width
time frame: baseline (immediately after extraction) - After 2 months
description: (Measured from the buccal to palatal plate of bone using bone caliper)
measure: Collagen surface area
time frame: after 2 months
measure: Average tabecular size
time frame: after 2 months
arm group label: PRGF/ATV
arm group type: Experimental
description: Included 10 patients undergoing single tooth extraction and platelet rich in growth factors fibrin scaffold loaded with Atorvastatin powder (PRGF/ATV) were placed to fill the extraction socket.
arm group label: ATV gel
arm group type: Experimental
description: Included 10 patients undergoing single tooth extraction and Atorvastatin gel were placed to fill the extraction socket.
arm group label: PRF
arm group type: Experimental
description: Included 10 patients undergoing single tooth extraction and platelet rich fibrin (PRF) were placed to fill the extraction socket.
arm group label: PRGF
arm group type: Experimental
description: Included 10 patients undergoing single tooth extraction and plasma rich in growth factors (PRGF) were placed to fill the extraction socket.
arm group label: Control
arm group type: No Intervention
description: Spontaneously healed socket
intervention type: Combination Product
intervention name: PRGF/ATV
description: Atorvastatin (ATV) loaded on plasma rich in growth factor (PRGF) Derived Fibrin Scaffold
arm group label: PRGF/ATV
intervention type: Drug
intervention name: ATV gel
description: Atorvastatin gel
arm group label: ATV gel
intervention type: Biological
intervention name: PRF
description: Platelet rich fibrin
arm group label: PRF
intervention type: Biological
intervention name: PRGF
description: plasma rich in growth factor
arm group label: PRGF
criteria: 
gender: All
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Ola Mohamed Ezzatt
investigator title: Lecturer Dr.
sharing ipd: Undecided