The Effect of Platelet Rich Fibrin Matrix With and Without Peripheral Blood Mesenchymal Stem Cells on Implant Stability
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
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.
研究概览
详细说明
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.
研究类型
注册 (预期的)
阶段
- 阶段1
联系人和位置
学习联系方式
- 姓名:Laveena Singhal, 1 MDS
- 电话号码:9900330579
- 邮箱:laveenasinghal13@gmail.com
研究联系人备份
- 姓名:Sphoorthi A Belludi, MDS
- 电话号码:9916010380
- 邮箱:doc_sphoo@yahoo.com
学习地点
-
-
Karnataka
-
Bengaluru、Karnataka、印度、560022
- 招聘中
- Kle Society'S Institute of Dental Sciences
-
接触:
- laveena singhal, mds
- 电话号码:9900330579
- 邮箱:laveenasinghal13@gmail.com
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patient with age group between 25-50 years
- Radiographic imaging(IOPA/OPG/CBCT/RVG) of the area of interest showing sufficient residual bone volume to receive two or more adjacent implants of ≥ 3.5 mm in diameter and 11.0 mm in length
- Extraction at least 6 months prior to the study.
Exclusion Criteria:
- Para-functional habits
- Smoking more than 10 cigarettes per day
- Excessive consumption of alcohol
- Patient's with systemic diseases contraindicated for surgery
- Localized radiotherapy, Antitumor chemotherapy of the oral cavity
- Liver, blood, and/or kidney diseases
- Immunosuppression
- Current corticosteroid or bisphosphonate use;
- Pregnancy
- Mucocutaneous diseases involving the oral cavity and
- Poor oral hygiene.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
有源比较器:Dental Implant with PRFM
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
|
placement of a minimum of two adjacent dental implants being randomly assigned into (G1) - Dental implant with PRFM
|
实验性的:Dental Implant with PRFM and PBMSCs
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
|
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.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Insertion torque values at the time of placement of dental implant
大体时间:on the implant placement day
|
insertion torque values will be recorded during the day of placement of implants.
|
on the implant placement day
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Implant stability quotient (ISQ) using Resonance frequency analysis (RFA).
大体时间:3 months
|
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
|
3 months
|
合作者和调查者
调查人员
- 首席研究员:Sudhir R Patil, MDS、Kle Society'S Institute of Dental Sciences
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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其他研究编号
- KLESInstitute
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IPD 计划说明
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