xml: <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/NCT06016218</url>
    </required_header>
    <id_info>
      <org_study_id>260981</org_study_id>
      <nct_id>NCT06016218</nct_id>
    </id_info>
    <brief_title>Effect of Local Application of Simvastatin Versus Bone Powder on Implant Bone Changes</brief_title>
    <official_title>Effect of Local Application of Platelet-Rich Fibrin Scaffold Loaded With Simvastatin Versus Bone Powder on Peri-Implant Bone Changes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>British University In Egypt</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>British University In Egypt</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study is conducted A- To investigate that PRF loaded with osteopromotive pharmacological&#xD;
        drug can be a great aid in implant rehabilitation, and whether it could be a replacement for&#xD;
        the other high price bone graft materials or not.&#xD;
  &#xD;
        This will be done through:&#xD;
  &#xD;
          1. Measuring bone changes around the implant by cone beam&#xD;
  &#xD;
          2. Measuring change in bone density around the implants&#xD;
  &#xD;
        B- Evaluate the effect of statins on osteoblasts activity and expression of various&#xD;
        osteogenic products in vitro.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Twenty four patients requiring rehabilitation by immediate implantation in an extraction&#xD;
        socket were recruited for this study. The Patients were divided into three groups (n=8), For&#xD;
        the first group; immediately after extraction, PRF alone was added into the extraction socket&#xD;
        prior to implant insertion. For the second group, PRF + 1.2mg Statin powder are inserted into&#xD;
        the extraction site before implant insertion. For the third Group; PRF + Bone powder are&#xD;
        inserted into the extraction site before implant insertion. A conebeam CT was used to&#xD;
        evaluate the effect on bone changes and bone density around implant sites, for every patient&#xD;
        in all implant groups immediately after the surgery and at follow-up time. In vitro&#xD;
        experiment: isolation of human Adipose mesenchymal stem cells (hAd-MSCs), characterization&#xD;
        and osteogenic differentiation will be done. The cells were divided into two groups one&#xD;
        control group and the other statin group. Osteogenic markers were measured in both groups and&#xD;
        statistical analysis performed&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 5, 2021</start_date>
    <completion_date type="Actual">February 5, 2023</completion_date>
    <primary_completion_date type="Actual">January 5, 2022</primary_completion_date>
    <phase>Phase 1/Phase 2</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Changes in crestal peri-imlant Bone</measure>
      <time_frame>12 months</time_frame>
      <description>Radiographic evaluation of crestal bone changes around the studied implants</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">24</enrollment>
    <condition>Dental Caries Extending to Pulp</condition>
    <condition>Dental Implant Failed</condition>
    <arm_group>
      <arm_group_label>PRF</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>PRF alone was added to extraction site prior to implant insertion</description>
    </arm_group>
    <arm_group>
      <arm_group_label>SIM+ PRF</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>PRF + 1.2mg Statin powder are inserted into the extraction site before implant insertion</description>
    </arm_group>
    <arm_group>
      <arm_group_label>BO+ PRF</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>PRF + Bone powder are inserted into the extraction site before implant insertion.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Simvastatin</intervention_name>
      <description>Comparing Simvastatin powder with PRF to Bone Powder with PRF on Peri-implant Bone</description>
      <arm_group_label>BO+ PRF</arm_group_label>
      <arm_group_label>PRF</arm_group_label>
      <arm_group_label>SIM+ PRF</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Badly Broken Down Tooth requiring extraction&#xD;
  &#xD;
            -  Medically Free&#xD;
  &#xD;
            -  Any other procedures or surgeries were performed 6 months earlier&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  patients with systemic diseases affecting bone quality or resorption&#xD;
  &#xD;
            -  temporomandibular joint dysfunction&#xD;
  &#xD;
            -  severe attrition or parafunctional habits&#xD;
  &#xD;
            -  patients undergoing radiotherapy or chemotherapy&#xD;
  &#xD;
            -  heavy smokers&#xD;
  &#xD;
            -  vulnerable groups like psychologically unstable patients.&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>45 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>The British University in Egypt</name>
        <address>
          <city>Cairo</city>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 12, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dental Caries</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Simvastatin</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06016218
  org study id: 260981
  nct id: NCT06016218
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  This study is conducted A- To investigate that PRF loaded with osteopromotive pharmacological
        drug can be a great aid in implant rehabilitation, and whether it could be a replacement for
        the other high price bone graft materials or not.
  
        This will be done through:
  
          1. Measuring bone changes around the implant by cone beam
  
          2. Measuring change in bone density around the implants
  
        B- Evaluate the effect of statins on osteoblasts activity and expression of various
        osteogenic products in vitro.
  Twenty four patients requiring rehabilitation by immediate implantation in an extraction
        socket were recruited for this study. The Patients were divided into three groups (n=8), For
        the first group; immediately after extraction, PRF alone was added into the extraction socket
        prior to implant insertion. For the second group, PRF + 1.2mg Statin powder are inserted into
        the extraction site before implant insertion. For the third Group; PRF + Bone powder are
        inserted into the extraction site before implant insertion. A conebeam CT was used to
        evaluate the effect on bone changes and bone density around implant sites, for every patient
        in all implant groups immediately after the surgery and at follow-up time. In vitro
        experiment: isolation of human Adipose mesenchymal stem cells (hAd-MSCs), characterization
        and osteogenic differentiation will be done. The cells were divided into two groups one
        control group and the other statin group. Osteogenic markers were measured in both groups and
        statistical analysis performed
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Outcomes Assessor)
  measure: Changes in crestal peri-imlant Bone
  time frame: 12 months
  description: Radiographic evaluation of crestal bone changes around the studied implants
  arm group label: PRF
  arm group type: Placebo Comparator
  description: PRF alone was added to extraction site prior to implant insertion
  arm group label: SIM+ PRF
  arm group type: Active Comparator
  description: PRF + 1.2mg Statin powder are inserted into the extraction site before implant insertion
  arm group label: BO+ PRF
  arm group type: Active Comparator
  description: PRF + Bone powder are inserted into the extraction site before implant insertion.
  intervention type: Drug
  intervention name: Simvastatin
  description: Comparing Simvastatin powder with PRF to Bone Powder with PRF on Peri-implant Bone
  arm group label: BO+ PRF
  arm group label: PRF
  arm group label: SIM+ PRF
  criteria: 
  gender: Male
  minimum age: 45 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Egypt
  responsible party type: Sponsor
  mesh term: Dental Caries
  mesh term: Simvastatin
  sharing ipd: No