<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/NCT03228771</url>
  </required_header>
  <id_info>
    <org_study_id>FDASU-RECM041515</org_study_id>
    <nct_id>NCT03228771</nct_id>
  </id_info>
  <brief_title>Socket Augmentation Using Atorvastatin With Or Without PRGF (Clinical and Histomorphometric Study)</brief_title>
  <official_title>Socket Augmentation Using Atorvastatin With Or Without PRGF Derived Fibrin Scaffold (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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Despite the numerous studies describing the benefits of PRGF (plasma rich in growth factors)&#xD;
      and Statins separately , there has been a lack of clinical investigation into the&#xD;
      simultaneous use of these agents in socket augmentation. Therefore the main objective of this&#xD;
      study is to evaluate socket bone dimensions and quality following the use of PRGF derived&#xD;
      fibrin scaffold as a carrier for Atorvastatin in socket augmentation clinically and&#xD;
      histomorphometrically.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite the numerous studies describing the benefits of PRGF (plasma rich in growth factors)&#xD;
      and Statins separately , there has been a lack of clinical investigation into the&#xD;
      simultaneous use of these agents in socket augmentation.&#xD;
&#xD;
      Plasma Rich in Growth Factors (PRGF) have given rise to an optimized and safer product rich&#xD;
      in growth factors which might be essential to proper tissue repair and wound healing. PRGF&#xD;
      acts on already differentiated cells, such as preosteoblasts and osteoblasts. However , they&#xD;
      do not exert any effects on the stem cells present in bone tissue, whose differentiation is&#xD;
      regulated by bone morphogenetic proteins (BMPs). Some pharmacologic compounds could offer a&#xD;
      safe and cost effective alternative to this problem and can affect bone regeneration. Statins&#xD;
      are widely used group of cholesterol lowering drugs that act on the mevalonate pathway by&#xD;
      being a competitive inhibitors of the rate limiting enzyme 3-hydroxy-3-methylglutaryl&#xD;
      coenzyme A (CoA) reductase (HMG-CoA reductase). Statins increase normal bone formation by&#xD;
      promoting osteoblast proliferation and differentiation and protecting the osteoblasts from&#xD;
      apoptosis. In addition, they reduce osteoclastogenesis by inhibiting osteoclastic&#xD;
      differentiation. Statins increase BMP-2 gene expression and subsequently promote bone&#xD;
      formation.This study hypothesized that use of PRGF fibrin scaffold in socket preservation&#xD;
      owing to its biocompatibility, ease of use, stimulation of production of growth factors and&#xD;
      its effect on the already differentiated osteoblasts, when combined with statin with its&#xD;
      effect on progenitor stem-cells could stimulate the differentiation of stem cells to&#xD;
      osteoblasts, prevent bone resorption and stimulate bone formation at the extraction socket.&#xD;
      Therefore the main objective of this study is to evaluate socket bone dimensions and quality&#xD;
      following the use of PRGF derived fibrin scaffold as a carrier for Atorvastatin in socket&#xD;
      augmentation clinically and histomorphometrically.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2016</start_date>
  <completion_date type="Actual">August 15, 2018</completion_date>
  <primary_completion_date type="Actual">June 2018</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>
    <intervention_model_description>3 Groups: Group 1: statin loaded in PRGF Group 2: statin loaded in methylcellulose gel Group 3: control</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>clinical measurements Ridge width</measure>
    <time_frame>1 year</time_frame>
    <description>Ridge width</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>clinical measurements ridge height</measure>
    <time_frame>1 year</time_frame>
    <description>Ridge height</description>
  </secondary_outcome>
  <other_outcome>
    <measure>histomorphometric analysis</measure>
    <time_frame>1 year</time_frame>
    <description>Bone core biopsy for histomorphometric analysis to measure osteoid tissues and mineralized bone</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Socket Preservation</condition>
  <arm_group>
    <arm_group_label>PRGF/ATV</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group I (PRGF/ATV) : It was included 10 patients undergoing single tooth extraction followed by socket fill with 1.2% Atorvastatin loaded in PRGF derived fibrin scaffold then suturing the socket. All patients will receive implants after taking the bone biopsy after 8 weeks for histomorphometric analysis.&#xD;
Intervention: Atorvastatin drug loaded in platelets rich in growth factors (PRGF).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ATV gel</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group II (ATV gel) : Will include 10 patients undergoing single tooth extraction followed by socket fill with 1.2% Atorvastatin in methyl cellulose gel then suturing the socket. All patients will receive implants after taking the bone biopsy after 8 weeks for histomorphometric analysis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Empty socket</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Group III Empty socket( control) : Will include 10 patients undergoing single tooth extraction then suturing the socket. All patients will receive implants after taking the bone biopsy after 8 weeks for histomorphometric analysis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PRGF/ATV</intervention_name>
    <description>Atorvastatin loaded in PRGF fibrin scaffold</description>
    <arm_group_label>PRGF/ATV</arm_group_label>
    <other_name>platelets rich in growth factors</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ATV gel</intervention_name>
    <description>Atorvastatin loaded in methyl cellulose gel</description>
    <arm_group_label>ATV gel</arm_group_label>
    <other_name>Atorvastatin gel</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adult patients as evidenced by Burkett's oral medicine health history&#xD;
             questionnaire.&#xD;
&#xD;
          -  Both sexes.&#xD;
&#xD;
          -  Age from 20 - 50 years old.&#xD;
&#xD;
          -  Having at least one hopeless tooth indicated for extraction.&#xD;
&#xD;
          -  Patient should agree to sign a written consent after the nature of the study will be&#xD;
             explained.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smokers.&#xD;
&#xD;
          -  Pregnant and breast feeding females.&#xD;
&#xD;
          -  Prisoners and handicapped patients.&#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>
  <overall_official>
    <last_name>Khaled A Ghaffar, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Ain Shams University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ola M Ezzatt, Lecturer</last_name>
    <role>Study Chair</role>
    <affiliation>Ain Shams University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of dentistry-Ain shams University</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>May 26, 2015</study_first_submitted>
  <study_first_submitted_qc>July 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>September 21, 2018</last_update_submitted>
  <last_update_submitted_qc>September 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Noha Nasr</investigator_full_name>
    <investigator_title>Researcher</investigator_title>
  </responsible_party>
  <keyword>PRGF</keyword>
  <keyword>Statins</keyword>
  <keyword>socket augmentation</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atorvastatin</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 18, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/71/NCT03228771/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 18, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/71/NCT03228771/SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 18, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/71/NCT03228771/SAP_002.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>May 10, 2019</submitted>
    <returned>July 18, 2019</returned>
  </pending_results>
  <!-- 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/NCT03228771
org study id: FDASU-RECM041515
nct id: NCT03228771
lead sponsor: 
has dmc: Yes
Despite the numerous studies describing the benefits of PRGF (plasma rich in growth factors)
      and Statins separately , there has been a lack of clinical investigation into the
      simultaneous use of these agents in socket augmentation. Therefore the main objective of this
      study is to evaluate socket bone dimensions and quality following the use of PRGF derived
      fibrin scaffold as a carrier for Atorvastatin in socket augmentation clinically and
      histomorphometrically.
Despite the numerous studies describing the benefits of PRGF (plasma rich in growth factors)
      and Statins separately , there has been a lack of clinical investigation into the
      simultaneous use of these agents in socket augmentation.

      Plasma Rich in Growth Factors (PRGF) have given rise to an optimized and safer product rich
      in growth factors which might be essential to proper tissue repair and wound healing. PRGF
      acts on already differentiated cells, such as preosteoblasts and osteoblasts. However , they
      do not exert any effects on the stem cells present in bone tissue, whose differentiation is
      regulated by bone morphogenetic proteins (BMPs). Some pharmacologic compounds could offer a
      safe and cost effective alternative to this problem and can affect bone regeneration. Statins
      are widely used group of cholesterol lowering drugs that act on the mevalonate pathway by
      being a competitive inhibitors of the rate limiting enzyme 3-hydroxy-3-methylglutaryl
      coenzyme A (CoA) reductase (HMG-CoA reductase). Statins increase normal bone formation by
      promoting osteoblast proliferation and differentiation and protecting the osteoblasts from
      apoptosis. In addition, they reduce osteoclastogenesis by inhibiting osteoclastic
      differentiation. Statins increase BMP-2 gene expression and subsequently promote bone
      formation.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.
      Therefore the main objective of this study is to evaluate socket bone dimensions and quality
      following the use of PRGF derived fibrin scaffold as a carrier for Atorvastatin in socket
      augmentation clinically and histomorphometrically.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 3 Groups: Group 1: statin loaded in PRGF Group 2: statin loaded in methylcellulose gel Group 3: control
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: clinical measurements Ridge width
time frame: 1 year
description: Ridge width
measure: clinical measurements ridge height
time frame: 1 year
description: Ridge height
measure: histomorphometric analysis
time frame: 1 year
description: Bone core biopsy for histomorphometric analysis to measure osteoid tissues and mineralized bone
arm group label: PRGF/ATV
arm group type: Active Comparator
description: Group I (PRGF/ATV) : It was included 10 patients undergoing single tooth extraction followed by socket fill with 1.2% Atorvastatin loaded in PRGF derived fibrin scaffold then suturing the socket. All patients will receive implants after taking the bone biopsy after 8 weeks for histomorphometric analysis.
Intervention: Atorvastatin drug loaded in platelets rich in growth factors (PRGF).
arm group label: ATV gel
arm group type: Active Comparator
description: Group II (ATV gel) : Will include 10 patients undergoing single tooth extraction followed by socket fill with 1.2% Atorvastatin in methyl cellulose gel then suturing the socket. All patients will receive implants after taking the bone biopsy after 8 weeks for histomorphometric analysis.
arm group label: Empty socket
arm group type: No Intervention
description: Group III Empty socket( control) : Will include 10 patients undergoing single tooth extraction then suturing the socket. All patients will receive implants after taking the bone biopsy after 8 weeks for histomorphometric analysis.
intervention type: Drug
intervention name: PRGF/ATV
description: Atorvastatin loaded in PRGF fibrin scaffold
arm group label: PRGF/ATV
other name: platelets rich in growth factors
intervention type: Drug
intervention name: ATV gel
description: Atorvastatin loaded in methyl cellulose gel
arm group label: ATV gel
other name: Atorvastatin gel
criteria: 
gender: All
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Khaled A Ghaffar, Professor
role: Study Director
affiliation: Ain Shams University
last name: Ola M Ezzatt, Lecturer
role: Study Chair
affiliation: Ain Shams University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Noha Nasr
investigator title: Researcher
mesh term: Atorvastatin
provided document: 
provided document: 
provided document: 
submitted: May 10, 2019
returned: July 18, 2019