跳至主要内容
临床试验/CTRI/2019/01/017056
CTRI/2019/01/017056尚未招募不适用

Comparison of role of Autologous Platelet rich plasma and dextrose prolotherapy in chronic degenerative disorders of temporomandibular joint: A pilot study

All India Institute of medical sciences1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年12月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
试验地点
1
主要终点
comparison of efficiency of PRP and dextrose in relieving TMD symptoms

研究概览

简要总结

Temporomandibular disorder (TMD) is one of the most common diseases causing chronic orofacial pain. Temporomandibular Joint (TMJ) is often predisposed to degenerative changes and pathologies as seen in other synovial joints, as a consequence of the frequent and repetitive stresses that the TMJ undergoes. Symptoms commonly associated with TMD include pain at the TMJ, generalized orofacial pain, chronic headaches and ear aches, jaw dysfunction, including limited movement or locking of the jaw, painful clicking or popping sounds with opening or closing of the mouth, and difficulty in chewing or speaking. Chronic pain is now recognized as a complex disorder that persists past the normal time of healing and as pain persists, psychosocial issues including depression, maladaptive beliefs about pain, medication abuse, strained interpersonal relationships andineffective coping strategies become prominent aspects of the disorder. For this disorders conservative measures like muscle relaxants, transcutaneous electrical neural stimulation (TENS), hot and cold fomentation, occlusal splints or intraarticular injections of steroids and hyaluronidase have been used. In non-refractory cases arthrocentesis and arthroscopic procedures are also done. Chronic cases not responding to any treatment may have to undergo open joint surgeries as well. For a chronic joint pain a therapy which can create a favorable environment for inflammation and augments the natural healing process of the body appears promising. This approach is referred to as Proliferation injection therapy/ Regenerative injection therapy popularly known as “Prolotherapyâ€. The agents used in prolotherapy are of four type’s namely osmotic agents, inflammatory mimetics, chemical irritants and physical irritants. Osmotic agent that is commonly used is 12.5% dextrose with local anesthetic agent. These agents produce a hypertonic extracellular environment and cause lysis of the adjacent cell walls. The resultant release of cellular proteins, inflammatory breakdown products of the cell wall and debris brings macrophages and granulocytes to the area and the desired localized inflammation and fibrous healing begin. Thus prolotherapy reinitiates the inflammatory process thereby augmenting the natural healing process of the body by stimulating fibroblastic activity. It can also induce the functional reactivation of tissues such as ligaments, disc and tendons.

Another kind of reparative injection therapy used for its varied regenerative and reparative is platelet rich plasma.Platelet rich plasma is a natural concentrate of autologous blood growth factor which is obtained by sequestering and concentrating platelets by gradient density centrifugation. It has been experimented in different fields of medicine in order to test its potential to enhance tissue regeneration. These platelets when activated undergo degranulation to release growth factors with healing properties. It also contains plasma, cytokines, thrombin, and other growth factors that are implicated in wound healing and have inherent biological and adhesive properties. The advantages of this method would be the safety of the material and a zero possibility of hypersensitivity to injected plasma. Clinically, it is used for neural damage, osteoarthropathy, myocardial injury, bone regeneration, and also in plastic surgery. There have been just a few studies for the treatment of TMD using PRP or prolotherapy with dextrose. These studies have mainly assessed pain as a factor.To the best of our knowledge no clinical studies assessing the overall symptoms related to TMD including the intensity of pain, range of motion, and TMJ sound have been conducted.Therefore the aim of this study is to evaluate and compare the efficacy of intraarticular injection therapy with 12.5% dextrose and platelet-rich plasma (PRP) for the patients who have the TMD symptoms of pain, restricted mouth opening, and TMJ sound.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • patients with internal derrangement of TMJ with pain, joint sounds and restricted mouth opening.

排除标准

  • patients with myofascial pain dysfunction syndrome
  • immunocompromised patients
  • patients with platelet disorders or who have taken NSAIDS in past one week or those who have undergone corticosteroid injection intra articular in last two months.

结局指标

主要结局

comparison of efficiency of PRP and dextrose in relieving TMD symptoms

时间窗: follow up weekly for 1 month and then at 2,4 and 6 months

次要结局

  • COMPLICATIONS ASSOCIATED(follow up weekly for 1 month and then at 2, 4 and 6 months)

研究者

申办方类型
Government medical college

研究点 (1)

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