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临床试验/NCT07078006
NCT07078006已完成不适用

Efficacy of Injectable Platelet Rich Fibrin Versus Platelet Rich Plasma Injection in Degenerative Temporomandibular Joint

Nasser Institute For Research and Treatment2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年2月22日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Pain improvement

研究概览

简要总结

The study aimed to compare the efficacy of injectable platelet rich fibrin (I-PRF) versus platelet rich plasma (PRP) injection in degenerative temporomandibular joint (TMJ).

详细描述

Degenerative joint disease (DJD), a frequently observed as osteoarthritic condition in clinical practice, manifests as a persistent and continuous transformation in joint configuration due to the deterioration and attrition of articular cartilage, accompanied by modifications in the subchondral bone and other soft tissue.

Treatment includes physical therapy, pulsed electrical stimulation, pharmacological, topical ointments, supplements, steroid injections, hyaluronic acid (HA) injections, and acupuncture.

Further studies have been carried out to better investigate the effectiveness of different techniques to perform arthrocentesis by using growth factors, autologous solutions, or alternative materials; the materials most used are platelet-rich plasma (PRP) and HA in arthrocentesis or by injection.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >18 years old.
  • Both sexes.
  • Patients with unilateral or bilateral temporomandibular joint (TMJ) osteoarthritis according to magnetic resonance imaging (MRI) evaluation.

排除标准

  • Patients under any type of antiplatelet or anticoagulant medications.
  • Cardiovascular, renal, or hepatic disease.
  • Diabetes.
  • Vascular insufficiency.
  • Peripheral neuropathy.
  • Previous surgery for TMJ and rheumatoid arthritis.

结局指标

主要结局

Pain improvement

时间窗: 6 months post-procedure

Each patient will be instructed about postoperative pain assessment with the Visual Analogue Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS was recorded preoperatively, immediately after the procedures, 1 month, 3 months, and 6 months postoperatively.

Pain improvement

时间窗: 6 months post-procedure

Each patient will be instructed about postoperative pain assessment with the Visual Analogue Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS was recorded preoperatively, immediately after the procedures, 1 month, 3 months, and 6 months postoperatively.

次要结局

  • Assessment of tissue repair(6 months post-procedure)
  • Assessment of tissue repair(6 months post-procedure)

研究者

发起方
Nasser Institute For Research and Treatment
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Omar Samir

Oral and Maxillofacial Surgery Department, Faculty of Oral & Dental Medicine, AL Azhar University, Assuit, Egypt.

Nasser Institute For Research and Treatment

研究点 (2)

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