Evaluation of Platelet Rich Fibrin Matrix(PRFM) as a Regenerative Material in Surgical Management of Human Periodontal Intraosseous Defects:A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Early wound healing index (EHI) was used to assess the wound healing potential of PRFM
研究概览
简要总结
Technological advancement has led to the development of concentrated platelets, by means of centrifugation, popularly known as Platelet concentrates which seem to be a convenient approach to obtain autologous growth factors. Locally delivered platelet concentrates are supposed to increase the proliferation of connective tissue progenitors to stimulate fibroblast and osteoblast activity and enhance angiogenesis, all of which are fundamental to tissue healing and regeneration. Several techniques for platelet concentrates are available, each method leading to a different product with different biology and potential use. Different platelet concentrates are classified, depending on their leucocyte and fibrin content. Conventional platelet rich plasma (PRP), also known as first generation platelet concentrate is plasma with a platelet concentration above the normal physiologic levels found in blood.
Platelet Rich Fibrin Matrix (PRFM) is an autologous biologic material created by two step centrifugation of whole blood without the use of exogenous thrombin. 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. PRFM possesses the ability to enhance tissue repair by isolation, concentration and preservation of autologous platelets in a dense scaffold like fibrin matrix. The viable platelets contain intrinsic growth factors which are probably released in a desired spatial and temporal manner that affect every aspect of soft tissue and osseous healing.
Very limited studies have been conducted to assess the regenerative potential of this new modality i.e. PRFM. This study therefore aims at the evaluation of platelet rich fibrin matrix as a potential regenerative material in comparison with open flap debridement in human periodontal intraosseous defects.
详细描述
Periodontitis is a chronic inflammatory disease caused by bacterial Plaque, the onset and progression of which is modulated by a variety of risk factors such as systemic conditions and smoking. It causes pathological alterations of the periodontium, resulting in loss of connective tissue attachment to the tooth, apical migration of the junctional epithelium along the root surface and loss of supporting alveolar bone. If left untreated, cases of periodontal disease can lead to premature tooth loss. However, the complex structure of periodontium, which consist of soft connective tissue of gingiva and periodontal ligament, as well as the mineralized tissues, cementum and bone, makes periodontal wound healing a unique process.
Although, all the tissues of the periodontium get affected, the crux of the problem of chronic periodontal diseases lies in the changes that occur in the bone resulting in intraosseous defects of various architecture, the persistence of which even after completion of active periodontal treatment may increase the site-specific risk of progression of periodontitis.
The two primary components of periodontal therapy involves, the elimination of the periodontal infection by eliminating the pathogenic periodontal microflora which induces favourable clinical changes in the periodontium and substantial efforts should be made to alter the anatomic defect resulting from active periodontitis.
The resective surgical approach and mucogingival surgeries (MGS) were the major periodontal therapies until the 1970s. However, problems with esthetics, root sensitivity and root caries resulting from resective therapy for severe periodontitis were eventually pointed out. Also resective procedure was admitted to be a "Repair" and not "Regeneration" which has long been the goal of periodontal therapy. The past two decades has seen a radical change in periodontal surgery with a shift from resective periodontal surgery to regenerative therapies. Also the concept of treatment has changed towards regeneration with a goal of regaining natural periodontal apparatus.
Conventional surgical approaches (e.g., flap debridement) continue to offer time-tested and reliable methods to access root surfaces, reduce periodontal pockets and attain improved periodontal form/architecture. However, these techniques offer only limited potential to recover tissues, destroyed during earlier disease phases.
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
- None
入排标准
- 年龄范围
- 30 Years 至 55 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy patients diagnosed with chronic periodontitis.
- •Patients with bilateral infra bony 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.
研究组 & 干预措施
Platelet rich fibrin matrix
surgical open flap debridement with Application of Platelet rich fibrin matrix using Platelet Rich Fibrin Matrix kit in 15 intrabony defect sites
干预措施: Platelet Rich Fibrin Matrix kit (Biological)
surgical open flap debridement
only surgical open flap debridement was done without application of Platelet rich fibrin matrix in 15 intrabony defect sites
干预措施: surgical open flap debridement (Procedure)
结局指标
主要结局
Early wound healing index (EHI) was used to assess the wound healing potential of PRFM
时间窗: 1 week
Early wound healing index (EHI) was used to assess the wound healing potential of PRFM at 1 week.
the clinical change in regenerative potential of platelet rich fibrin matrix (PRFM) and open flap debridement (OFD) and OFD alone in periodontal defects.
时间窗: baseline,3 months and 6 months
Clinical parameters(plaque index, gingival index, probing pocket depth,attachment level)were combined to assess the change in the regenerative potential
change in the radiographic parameters in both the groups i.e,PRFM+OFD and OFD alone
时间窗: baseline,3 months,6 months
radiographic evidence of bilateral vertical osseous defects were categorized into test group \[OFD + PRFM and control group \[open flap debridement (OFD)\]
次要结局
未报告次要终点
研究者
Dr Laveena Singhal
Principal investigator
KLE Society's Institute of Dental Sciences
