<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/NCT03766139</url>
  </required_header>
  <id_info>
    <org_study_id>PARVATHY61</org_study_id>
    <nct_id>NCT03766139</nct_id>
  </id_info>
  <brief_title>Regenerative Potential of Supercell Glue and Platelet Rich Fibrin Matrix</brief_title>
  <official_title>Evaluation of Supercell Glue (Platelet Rich Fibrin Matrix{PRFM} AND Peripheral Blood Mesenchymal Stem Cells {PBMSCs} ) as a Regenerative Material in Human Mandibular Periodontal Intraosseous Defect - A Split Mouth Randomized Controlled 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Utilizing the osteogenic properties of both platelet rich fibrin matrix and peripheral blood&#xD;
      mesenchymal stem cells for periodontal regeneration would be novel and may be advantageous&#xD;
      than using Platelet rich fibrin matrix alone. The literature search does not show any human&#xD;
      clinical trial conducted till date to assess the regenerative potential of this new material&#xD;
      i.e. Supercell glue (PRFM and PBMSCs).In this new material because of the addition of a&#xD;
      patented gel the second spin to procure the PRFM has been eliminated and this seems to be an&#xD;
      additional advantage. This study therefore aims at the evaluation of Supercell glue (PRFM and&#xD;
      PBMSCs) as a regenerative material in comparison with PRFM alone in human mandibular&#xD;
      periodontal intraosseous defects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Periodontal regeneration involves the formation of alveolar bone, cementum and a new&#xD;
      functional periodontal ligament. Over the recent years the concept of periodontal treatment&#xD;
      has focused towards regeneration with a goal of regaining natural periodontal apparatus.&#xD;
      Numerous procedures have been investigated in the past to try to promote periodontal&#xD;
      regeneration which range from root biomodifications, soft tissue grafts, bone replacement&#xD;
      grafts, guided tissue regeneration to the use of combinations of the same. However the&#xD;
      success of these approaches are highly variable. As a consequence current research trends are&#xD;
      inclined towards the principle of 'biological solutions for biological problem' and thus&#xD;
      attempts are directed towards various approaches like tissue engineering, ERT (endogenous&#xD;
      regenerative technology), application of biologics, cell based techniques, biomimetic&#xD;
      nanoscaffold fabrication and others for periodontal regeneration. Of all known Polypeptide&#xD;
      Growth Factors, Platelet Derived Growth Factor (PDGF) and Transforming Growth Factor β (TGF&#xD;
      β) which are abundant in α granule of platelets are shown to exert a favourable effect on&#xD;
      periodontal regeneration. Therefore use of platelet concentrates is a convenient approach to&#xD;
      obtain autologous growth factors.&#xD;
&#xD;
      Platelet rich fibrin matrix (PRFM) is an autologous concentrated platelet-rich thrombin free&#xD;
      fibrin matrix, prepared by two step centrifugation of blood. Platelets isolated, remain&#xD;
      intact and retain their growth factor compliment. This allows a more effective, sustained&#xD;
      release of growth factors to the wound site following PRFM application. During the second&#xD;
      spin, a cross-linking of fibrin takes place, resulting in the formation of a dense fibrin&#xD;
      matrix, within which a concentration of viable platelets can be found. Having an organized&#xD;
      fibrin matrix at the start of healing accelerates the speed of vascular ingress into the&#xD;
      wound compared to non-accelerated healing, which requires a longer time for fibrin formation&#xD;
      and the development of vascularity. The earlier the vascularity is established, faster is the&#xD;
      migration of the bone-forming cells at the wound site and initiation of bone formation.&#xD;
      Therapeutic applications of platelet-rich products have led to improved bone regeneration.&#xD;
&#xD;
      Mesenchymal stem cells (MSCs) are a multipotent stromal cells with prominent regenerative&#xD;
      functions. MSCs were first identified and isolated from bone marrow and then found in various&#xD;
      tissues including umbilical cord, adipose tissue and peripheral blood. Among these sources&#xD;
      peripheral blood MSCs draw increasing attention as they share similar biological&#xD;
      characteristics with MSCs derived from bone marrow or adipose tissue. Bone marrow derived&#xD;
      mesenchymal stem cells(BMMSCs) are multipotent cells capable of differentiating into&#xD;
      osteoblasts, chondrocytes, adipocytes, fibroblasts, tenocytes, and myoblasts, which are&#xD;
      considered as a cell source for various tissue repair and regenerating bone defects. The&#xD;
      requirements of aspiration of bone marrow from the patient will cause pain and morbidity of&#xD;
      the donor sites. It will be very convenient if peripheral blood mesenchymal stem cells&#xD;
      (PBMSCs) could be harvested and expanded to enough numbers, with their osteogenic capacity&#xD;
      maintained in a clinical permitted period.&#xD;
&#xD;
      Hence, utilizing the osteogenic properties of both platelet rich fibrin matrix and peripheral&#xD;
      blood mesenchymal stem cells for periodontal regeneration would be novel and may be&#xD;
      advantageous than using Platelet rich fibrin matrix alone. The literature search does not&#xD;
      show any human clinical trial conducted till date to assess the regenerative potential of&#xD;
      this new material i.e. Supercell glue (PRFM and PBMSCs).In this new material because of the&#xD;
      addition of a patented gel the second spin to procure the PRFM has been eliminated and this&#xD;
      seems to be an additional advantage. This study therefore aims at the evaluation of Supercell&#xD;
      glue (PRFM and PBMSCs) as a regenerative material in comparison with PRFM alone in human&#xD;
      mandibular periodontal intraosseous defects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">December 2018</start_date>
  <completion_date type="Anticipated">November 2019</completion_date>
  <primary_completion_date type="Anticipated">June 2019</primary_completion_date>
  <phase>Early 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 study will be a Double Blinded Randomized controlled clinical trial with a split mouth design.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>The sites will be randomly (computer generated tabulation method) assigned into control group (treated with PRFM alone) and test group (treated with Supercell Glue).</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Early wound healing index (Supercell in early wound healing index)</measure>
    <time_frame>1 week</time_frame>
    <description>early wound healing index in intraosseous periodontal defects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in probing pocket depth and clinical attachment gain (Supercell as a regenerative novel material)</measure>
    <time_frame>baseline,3 months,6 months</time_frame>
    <description>Change in probing pocket depth reduction and clinical attachment gain measured in millimetres in intraosseous defects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the bone level (Supercell as a biological material)</measure>
    <time_frame>baseline, 3 months,6 months</time_frame>
    <description>change in the bone level will be assessed radiographically using Image J analysis software measured in millimeters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the clinical parameters of gingival index and plaque index (Supercell as a regenerative material using clinical indices)</measure>
    <time_frame>baseline,3 months,6 months</time_frame>
    <description>change in the clinical parameters of gingival index and plaque index (no units as these are indices) in intraosseous periodontal defects</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">17</enrollment>
  <condition>Intrabony Periodontal Defect</condition>
  <arm_group>
    <arm_group_label>SUPERCELL GLUE(STEM CELLS AND PRFM)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Following optimum anaesthesia, reflection of full thickness mucoperiosteal flaps for defect access and thorough debridement will be done. Subsequently the defect will be filled with supercell glue in test sites .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PRFM ALONE</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Following optimum anaesthesia, reflection of full thickness mucoperiosteal flaps for defect access and thorough debridement will be done. Subsequently the defect will be filled with PRFM in control sites</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>SUPERCELL GLUE</intervention_name>
    <description>Following optimum anaesthesia, reflection of full thickness mucoperiosteal flaps for defect access and thorough debridement will be done. Subsequently the defect will be filled with supercell glue in test sites (randomly selected by computer generated tabulation method)</description>
    <arm_group_label>SUPERCELL GLUE(STEM CELLS AND PRFM)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PRFM ALONE</intervention_name>
    <description>Following optimum anaesthesia, reflection of full thickness mucoperiosteal flaps for defect access and thorough debridement will be done. Subsequently the defect will be filled with PRFM in control sites(randomly selected by computer generated tabulation method)</description>
    <arm_group_label>PRFM ALONE</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Systemically healthy patients diagnosed with chronic periodontitis.&#xD;
&#xD;
          -  Patients with mandibular infrabony pocket measuring ≥ 6mm with radiographic evidence&#xD;
             of intrabony defect&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant /lactating women&#xD;
&#xD;
          -  Patients taking any drug known to affect the number and function of platelets in the&#xD;
             past 3 months.&#xD;
&#xD;
          -  Patients with abnormal platelet count.&#xD;
&#xD;
          -  Patients with immunologic diseases&#xD;
&#xD;
          -  Current smokers.&#xD;
&#xD;
          -  History of periodontal therapy in the last 6 months.&#xD;
&#xD;
          -  Any other contraindications for periodontal surgery.&#xD;
&#xD;
          -  Maxillary intrabony defect.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kle Society'S Institute of Dental Sciences</name>
      <address>
        <city>Bangalore</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>
    <contact_backup>
      <last_name>SREEPARVATHY R, MDS</last_name>
      <phone>8050377024</phone>
      <email>nairsreeparvathy61@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>August 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>December 5, 2018</last_update_submitted>
  <last_update_submitted_qc>December 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2018</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>Principal investigator</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/NCT03766139
org study id: PARVATHY61
nct id: NCT03766139
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Utilizing the osteogenic properties of both platelet rich fibrin matrix and peripheral blood
      mesenchymal stem cells for periodontal regeneration would be novel and may be advantageous
      than using Platelet rich fibrin matrix alone. The literature search does not show any human
      clinical trial conducted till date to assess the regenerative potential of this new material
      i.e. Supercell glue (PRFM and PBMSCs).In this new material because of the addition of a
      patented gel the second spin to procure the PRFM has been eliminated and this seems to be an
      additional advantage. This study therefore aims at the evaluation of Supercell glue (PRFM and
      PBMSCs) as a regenerative material in comparison with PRFM alone in human mandibular
      periodontal intraosseous defects.
Periodontal regeneration involves the formation of alveolar bone, cementum and a new
      functional periodontal ligament. Over the recent years the concept of periodontal treatment
      has focused towards regeneration with a goal of regaining natural periodontal apparatus.
      Numerous procedures have been investigated in the past to try to promote periodontal
      regeneration which range from root biomodifications, soft tissue grafts, bone replacement
      grafts, guided tissue regeneration to the use of combinations of the same. However the
      success of these approaches are highly variable. As a consequence current research trends are
      inclined towards the principle of 'biological solutions for biological problem' and thus
      attempts are directed towards various approaches like tissue engineering, ERT (endogenous
      regenerative technology), application of biologics, cell based techniques, biomimetic
      nanoscaffold fabrication and others for periodontal regeneration. Of all known Polypeptide
      Growth Factors, Platelet Derived Growth Factor (PDGF) and Transforming Growth Factor β (TGF
      β) which are abundant in α granule of platelets are shown to exert a favourable effect on
      periodontal regeneration. Therefore use of platelet concentrates is a convenient approach to
      obtain autologous growth factors.

      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. 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.

      Mesenchymal stem cells (MSCs) are a multipotent stromal cells 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. 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.

      Hence, utilizing the osteogenic properties of both platelet rich fibrin matrix and peripheral
      blood mesenchymal stem cells for periodontal regeneration would be novel and may be
      advantageous than using Platelet rich fibrin matrix alone. The literature search does not
      show any human clinical trial conducted till date to assess the regenerative potential of
      this new material i.e. Supercell glue (PRFM and PBMSCs).In this new material because of the
      addition of a patented gel the second spin to procure the PRFM has been eliminated and this
      seems to be an additional advantage. This study therefore aims at the evaluation of Supercell
      glue (PRFM and PBMSCs) as a regenerative material in comparison with PRFM alone in human
      mandibular periodontal intraosseous defects.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The study will be a Double Blinded Randomized controlled clinical trial with a split mouth design.
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: The sites will be randomly (computer generated tabulation method) assigned into control group (treated with PRFM alone) and test group (treated with Supercell Glue).
measure: Early wound healing index (Supercell in early wound healing index)
time frame: 1 week
description: early wound healing index in intraosseous periodontal defects
measure: Change in probing pocket depth and clinical attachment gain (Supercell as a regenerative novel material)
time frame: baseline,3 months,6 months
description: Change in probing pocket depth reduction and clinical attachment gain measured in millimetres in intraosseous defects
measure: Change in the bone level (Supercell as a biological material)
time frame: baseline, 3 months,6 months
description: change in the bone level will be assessed radiographically using Image J analysis software measured in millimeters
measure: Change in the clinical parameters of gingival index and plaque index (Supercell as a regenerative material using clinical indices)
time frame: baseline,3 months,6 months
description: change in the clinical parameters of gingival index and plaque index (no units as these are indices) in intraosseous periodontal defects
arm group label: SUPERCELL GLUE(STEM CELLS AND PRFM)
arm group type: Experimental
description: Following optimum anaesthesia, reflection of full thickness mucoperiosteal flaps for defect access and thorough debridement will be done. Subsequently the defect will be filled with supercell glue in test sites .
arm group label: PRFM ALONE
arm group type: Active Comparator
description: Following optimum anaesthesia, reflection of full thickness mucoperiosteal flaps for defect access and thorough debridement will be done. Subsequently the defect will be filled with PRFM in control sites
intervention type: Biological
intervention name: SUPERCELL GLUE
description: Following optimum anaesthesia, reflection of full thickness mucoperiosteal flaps for defect access and thorough debridement will be done. Subsequently the defect will be filled with supercell glue in test sites (randomly selected by computer generated tabulation method)
arm group label: SUPERCELL GLUE(STEM CELLS AND PRFM)
intervention type: Biological
intervention name: PRFM ALONE
description: Following optimum anaesthesia, reflection of full thickness mucoperiosteal flaps for defect access and thorough debridement will be done. Subsequently the defect will be filled with PRFM in control sites(randomly selected by computer generated tabulation method)
arm group label: PRFM ALONE
criteria: 
gender: All
minimum age: 25 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
contact backup: 
country: India
responsible party type: Principal Investigator
investigator affiliation: KLE Society's Institute of Dental Sciences
investigator full name: Dr Laveena Singhal
investigator title: Principal investigator
sharing ipd: Undecided