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Regenerative Potential of Supercell Glue and Platelet Rich Fibrin Matrix

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ClinicalTrials.gov Identifier: NCT03766139
Recruitment Status : Recruiting
First Posted : December 6, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Dr Laveena Singhal, KLE Society's Institute of Dental Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Intrabony Periodontal Defect Biological: SUPERCELL GLUE Biological: PRFM ALONE Early Phase 1

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 17 participants
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.
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).
Primary Purpose: Treatment
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
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : November 2019

Arm Intervention/treatment
Experimental: SUPERCELL GLUE(STEM CELLS AND PRFM)
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 .
Biological: SUPERCELL GLUE
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)

Active Comparator: PRFM ALONE
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
Biological: PRFM ALONE
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)




Primary Outcome Measures :
  1. Early wound healing index (Supercell in early wound healing index) [ Time Frame: 1 week ]
    early wound healing index in intraosseous periodontal defects

  2. Change in probing pocket depth and clinical attachment gain (Supercell as a regenerative novel material) [ Time Frame: baseline,3 months,6 months ]
    Change in probing pocket depth reduction and clinical attachment gain measured in millimetres in intraosseous defects

  3. Change in the bone level (Supercell as a biological material) [ Time Frame: baseline, 3 months,6 months ]
    change in the bone level will be assessed radiographically using Image J analysis software measured in millimeters

  4. 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 ]
    change in the clinical parameters of gingival index and plaque index (no units as these are indices) in intraosseous periodontal defects



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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Systemically healthy patients diagnosed with chronic periodontitis.
  • Patients with mandibular infrabony pocket measuring ≥ 6mm with radiographic evidence of intrabony defect

Exclusion Criteria:

  • Pregnant /lactating women
  • Patients taking any drug known to affect the number and function of platelets in the past 3 months.
  • Patients with abnormal platelet count.
  • Patients with immunologic diseases
  • Current smokers.
  • History of periodontal therapy in the last 6 months.
  • Any other contraindications for periodontal surgery.
  • Maxillary intrabony defect.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03766139


Locations
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India
Kle Society'S Institute of Dental Sciences Recruiting
Bangalore, Karnataka, India, 560022
Contact: LAVEENA SINGHAL, MDS    9900330579    laveenasinghal13@gmail.com   
Contact: SREEPARVATHY R, MDS    8050377024    nairsreeparvathy61@gmail.com   
Sponsors and Collaborators
KLE Society's Institute of Dental Sciences

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Responsible Party: Dr Laveena Singhal, Principal investigator, KLE Society's Institute of Dental Sciences
ClinicalTrials.gov Identifier: NCT03766139     History of Changes
Other Study ID Numbers: PARVATHY61
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs