跳至主要内容
临床试验/NCT03766139
NCT03766139Unknown早期 1 期

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

KLE Society's Institute of Dental Sciences2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2018年12月最近更新:
适应症
干预措施

试验速览

阶段
早期 1 期
入组人数
17
试验地点
2
主要终点
Early wound healing index (Supercell in early wound healing index)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

盲法说明

The sites will be randomly (computer generated tabulation method) assigned into control group (treated with PRFM alone) and test group (treated with Supercell Glue).

入排标准

年龄范围
25 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

SUPERCELL GLUE(STEM CELLS AND PRFM)

Experimental

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 .

干预措施: SUPERCELL GLUE (Biological)

PRFM ALONE

Active Comparator

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

干预措施: PRFM ALONE (Biological)

结局指标

主要结局

Early wound healing index (Supercell in early wound healing index)

时间窗: 1 week

early wound healing index in intraosseous periodontal defects

Change in probing pocket depth and clinical attachment gain (Supercell as a regenerative novel material)

时间窗: baseline,3 months,6 months

Change in probing pocket depth reduction and clinical attachment gain measured in millimetres in intraosseous defects

Change in the clinical parameters of gingival index and plaque index (Supercell as a regenerative material using clinical indices)

时间窗: 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

Change in the bone level (Supercell as a biological material)

时间窗: baseline, 3 months,6 months

change in the bone level will be assessed radiographically using Image J analysis software measured in millimeters

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Laveena Singhal

Principal investigator

KLE Society's Institute of Dental Sciences

研究点 (2)

Loading locations...

相似试验