<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/NCT03044119</url>
  </required_header>
  <id_info>
    <org_study_id>KLESInstitute</org_study_id>
    <nct_id>NCT03044119</nct_id>
  </id_info>
  <brief_title>The Effect of Platelet Rich Fibrin Matrix With and Without Peripheral Blood Mesenchymal Stem Cells on Implant Stability</brief_title>
  <official_title>A Comparative Evaluation of the Effect of Platelet Rich Fibrin Matrix With and Without Peripheral Blood Mesenchymal Stem Cells on Implant Stability : A Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KLE Society's Institute of Dental Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>KLE Society's Institute of Dental Sciences</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Primary Objectives of the present study are :&#xD;
&#xD;
        -  To Evaluate the effect of platelet rich fibrin matrix (PRFM) and peripheral blood&#xD;
           mesenchymal stem cells (PBMSCs) on implant stability.&#xD;
&#xD;
        -  To Compare the effect of platelet rich fibrin matrix (PRFM) alone to peripheral blood&#xD;
           mesenchymal stem cells (PBMSCs) embedded in platelet rich fibrin matrix (PRFM) on&#xD;
           implant stability.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The addition of molecules or growth factors to the implant surface is an approach to enhance&#xD;
      bone to implant contact (BIC).1 Platelet rich fibrin matrix (PRFM) is an autologous&#xD;
      concentrated platelet-rich thrombin free fibrin matrix, prepared by two step centrifugation&#xD;
      of blood. Platelets isolated, remain intact and retain their growth factor compliment. This&#xD;
      allows a more effective, sustained release of growth factors to the wound site following PRFM&#xD;
      application.2 During the second spin, a cross-linking of fibrin takes place, resulting in the&#xD;
      formation of a dense fibrin matrix, within which a concentration of viable platelets can be&#xD;
      found. Having an organized fibrin matrix at the start of healing accelerates the speed of&#xD;
      vascular ingress into the wound compared to non-accelerated healing, which requires a longer&#xD;
      time for fibrin formation and the development of vascularity. The earlier the vascularity is&#xD;
      established, faster is the migration of the bone-forming cells at the wound site and&#xD;
      initiation of bone formation. Therapeutic applications of platelet-rich products have led to&#xD;
      improved bone regeneration and faster titanium implant osseointegration, which improve the&#xD;
      stability and maintenance of dental implants by increasing BIC.1 Mesenchymal stem cells&#xD;
      (MSCs) is a multipotent stromal cell with prominent regenerative functions. MSCs were first&#xD;
      identified and isolated from bone marrow and then found in various tissues including&#xD;
      umbilical cord, adipose tissue and peripheral blood. Among these sources peripheral blood&#xD;
      MSCs draw increasing attention as they share similar biological characteristics with MSCs&#xD;
      derived from bone marrow or adipose tissue. Bone marrow derived mesenchymal stem&#xD;
      cells(BMMSCs) are multipotent cells capable of differentiating into osteoblasts,&#xD;
      chondrocytes, adipocytes , fibroblasts, tenocytes, and myoblasts , which are considered as a&#xD;
      cell source for various tissue repair and regenerating bone defects.3 The requirements of&#xD;
      aspiration of bone marrow from the patient will cause pain and morbidity of the donor sites.&#xD;
      It will be very convenient if peripheral blood mesenchymal stem cells (PBMSCs) could be&#xD;
      harvested and expanded to enough numbers, with their osteogenic capacity maintained in a&#xD;
      clinical permitted period.&#xD;
&#xD;
      The literature search does not show any human clinical trial conducted till date to assess&#xD;
      the regenerative potential of this new modality i.e. PRFM and peripheral blood mesenchymal&#xD;
      stem cells. This study therefore aims at the evaluation of PRFM and PBMSCs as regenerative&#xD;
      materials for implant stability.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 15, 2018</start_date>
  <completion_date type="Anticipated">October 20, 2019</completion_date>
  <primary_completion_date type="Anticipated">July 20, 2019</primary_completion_date>
  <phase>Phase 1</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>The selected sites would be randomly (coin toss method) assigned into an edentulous area allowing for the placement of a minimum of two adjacent dental implants being randomly assigned into (G1) - Dental implant with PRFM and (G2) - Dental implant with peripheral blood mesenchymal stem cells embedded in PRFM.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>The selected sites would be randomly (coin toss method) assigned into an edentulous area .</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Insertion torque values at the time of placement of dental implant</measure>
    <time_frame>on the implant placement day</time_frame>
    <description>insertion torque values will be recorded during the day of placement of implants.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Implant stability quotient (ISQ) using Resonance frequency analysis (RFA).</measure>
    <time_frame>3 months</time_frame>
    <description>Implant stability quotient (ISQ) using Resonance frequency analysis (RFA) with the help of Osstell device at 1 week, 1 month and 3 months post operatively</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Dental Implants</condition>
  <arm_group>
    <arm_group_label>Dental Implant with PRFM</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention in the form of Dental Implants placement in the adjacent edentulous bone with the placement of platelet rich fibrin matrix a biological material procured from patient's peripheral blood</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dental Implant with PRFM and PBMSCs</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention in the form of Dental Implant placement in the adjacent edentulous bone with the placement of platelet rich fibrin matrix and peripheral blood mesenchymal stem cells which are the biological materials procured from patient's peripheral blood</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Dental Implant with PRFM</intervention_name>
    <description>placement of a minimum of two adjacent dental implants being randomly assigned into (G1) - Dental implant with PRFM</description>
    <arm_group_label>Dental Implant with PRFM</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Dental Implant with PRFM and PBMSCs</intervention_name>
    <description>placement of a minimum of two adjacent dental implants being randomly assigned into (G2) - Dental implant with peripheral blood mesenchymal stem cells embedded in PRFM.</description>
    <arm_group_label>Dental Implant with PRFM and PBMSCs</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with age group between 25-50 years&#xD;
&#xD;
          -  Radiographic imaging(IOPA/OPG/CBCT/RVG) of the area of interest showing sufficient&#xD;
             residual bone volume to receive two or more adjacent implants of ≥ 3.5 mm in diameter&#xD;
             and 11.0 mm in length&#xD;
&#xD;
          -  Extraction at least 6 months prior to the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Para-functional habits&#xD;
&#xD;
          -  Smoking more than 10 cigarettes per day&#xD;
&#xD;
          -  Excessive consumption of alcohol&#xD;
&#xD;
          -  Patient's with systemic diseases contraindicated for surgery&#xD;
&#xD;
          -  Localized radiotherapy, Antitumor chemotherapy of the oral cavity&#xD;
&#xD;
          -  Liver, blood, and/or kidney diseases&#xD;
&#xD;
          -  Immunosuppression&#xD;
&#xD;
          -  Current corticosteroid or bisphosphonate use;&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Mucocutaneous diseases involving the oral cavity and&#xD;
&#xD;
          -  Poor oral hygiene.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sudhir R Patil, MDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>KLE Society's Institute of Dental Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Laveena Singhal, 1 MDS</last_name>
    <phone>9900330579</phone>
    <email>laveenasinghal13@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sphoorthi A Belludi, MDS</last_name>
    <phone>9916010380</phone>
    <email>doc_sphoo@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Kle Society'S Institute of Dental Sciences</name>
      <address>
        <city>Bengaluru</city>
        <state>Karnataka</state>
        <zip>560022</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>laveena singhal, mds</last_name>
      <phone>9900330579</phone>
      <email>laveenasinghal13@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>February 2, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 6, 2017</study_first_posted>
  <last_update_submitted>January 14, 2019</last_update_submitted>
  <last_update_submitted_qc>January 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>KLE Society's Institute of Dental Sciences</investigator_affiliation>
    <investigator_full_name>Dr Laveena Singhal</investigator_full_name>
    <investigator_title>Dr Laveena</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>in the form of research publication</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/NCT03044119
org study id: KLESInstitute
nct id: NCT03044119
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The Primary Objectives of the present study are :

        -  To Evaluate the effect of platelet rich fibrin matrix (PRFM) and peripheral blood
           mesenchymal stem cells (PBMSCs) on implant stability.

        -  To Compare the effect of platelet rich fibrin matrix (PRFM) alone to peripheral blood
           mesenchymal stem cells (PBMSCs) embedded in platelet rich fibrin matrix (PRFM) on
           implant stability.
The addition of molecules or growth factors to the implant surface is an approach to enhance
      bone to implant contact (BIC).1 Platelet rich fibrin matrix (PRFM) is an autologous
      concentrated platelet-rich thrombin free fibrin matrix, prepared by two step centrifugation
      of blood. Platelets isolated, remain intact and retain their growth factor compliment. This
      allows a more effective, sustained release of growth factors to the wound site following PRFM
      application.2 During the second spin, a cross-linking of fibrin takes place, resulting in the
      formation of a dense fibrin matrix, within which a concentration of viable platelets can be
      found. Having an organized fibrin matrix at the start of healing accelerates the speed of
      vascular ingress into the wound compared to non-accelerated healing, which requires a longer
      time for fibrin formation and the development of vascularity. The earlier the vascularity is
      established, faster is the migration of the bone-forming cells at the wound site and
      initiation of bone formation. Therapeutic applications of platelet-rich products have led to
      improved bone regeneration and faster titanium implant osseointegration, which improve the
      stability and maintenance of dental implants by increasing BIC.1 Mesenchymal stem cells
      (MSCs) is a multipotent stromal cell with prominent regenerative functions. MSCs were first
      identified and isolated from bone marrow and then found in various tissues including
      umbilical cord, adipose tissue and peripheral blood. Among these sources peripheral blood
      MSCs draw increasing attention as they share similar biological characteristics with MSCs
      derived from bone marrow or adipose tissue. Bone marrow derived mesenchymal stem
      cells(BMMSCs) are multipotent cells capable of differentiating into osteoblasts,
      chondrocytes, adipocytes , fibroblasts, tenocytes, and myoblasts , which are considered as a
      cell source for various tissue repair and regenerating bone defects.3 The requirements of
      aspiration of bone marrow from the patient will cause pain and morbidity of the donor sites.
      It will be very convenient if peripheral blood mesenchymal stem cells (PBMSCs) could be
      harvested and expanded to enough numbers, with their osteogenic capacity maintained in a
      clinical permitted period.

      The literature search does not show any human clinical trial conducted till date to assess
      the regenerative potential of this new modality i.e. PRFM and peripheral blood mesenchymal
      stem cells. This study therefore aims at the evaluation of PRFM and PBMSCs as regenerative
      materials for implant stability.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The selected sites would be randomly (coin toss method) assigned into an edentulous area allowing for the placement of a minimum of two adjacent dental implants being randomly assigned into (G1) - Dental implant with PRFM and (G2) - Dental implant with peripheral blood mesenchymal stem cells embedded in PRFM.
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: The selected sites would be randomly (coin toss method) assigned into an edentulous area .
measure: Insertion torque values at the time of placement of dental implant
time frame: on the implant placement day
description: insertion torque values will be recorded during the day of placement of implants.
measure: Implant stability quotient (ISQ) using Resonance frequency analysis (RFA).
time frame: 3 months
description: Implant stability quotient (ISQ) using Resonance frequency analysis (RFA) with the help of Osstell device at 1 week, 1 month and 3 months post operatively
arm group label: Dental Implant with PRFM
arm group type: Active Comparator
description: Intervention in the form of Dental Implants placement in the adjacent edentulous bone with the placement of platelet rich fibrin matrix a biological material procured from patient's peripheral blood
arm group label: Dental Implant with PRFM and PBMSCs
arm group type: Experimental
description: Intervention in the form of Dental Implant placement in the adjacent edentulous bone with the placement of platelet rich fibrin matrix and peripheral blood mesenchymal stem cells which are the biological materials procured from patient's peripheral blood
intervention type: Biological
intervention name: Dental Implant with PRFM
description: placement of a minimum of two adjacent dental implants being randomly assigned into (G1) - Dental implant with PRFM
arm group label: Dental Implant with PRFM
intervention type: Biological
intervention name: Dental Implant with PRFM and PBMSCs
description: placement of a minimum of two adjacent dental implants being randomly assigned into (G2) - Dental implant with peripheral blood mesenchymal stem cells embedded in PRFM.
arm group label: Dental Implant with PRFM and PBMSCs
criteria: 
gender: All
minimum age: 25 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sudhir R Patil, MDS
role: Principal Investigator
affiliation: KLE Society's Institute of Dental Sciences
last name: Laveena Singhal, 1 MDS
phone: 9900330579
email: laveenasinghal13@gmail.com
last name: Sphoorthi A Belludi, MDS
phone: 9916010380
email: doc_sphoo@yahoo.com
facility: 
status: Recruiting
contact: 
country: India
responsible party type: Principal Investigator
investigator affiliation: KLE Society's Institute of Dental Sciences
investigator full name: Dr Laveena Singhal
investigator title: Dr Laveena
sharing ipd: Yes
ipd description: in the form of research publication