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临床试验/CTRI/2019/01/017076
CTRI/2019/01/017076已完成不适用

EFFICACY OF INTRA-ARTICULAR PLATELET RICH PLASMA VERSUS HYALURONIC ACID AFTER ARTHROCENTESIS FOR THE TREATMENT OF INTERNAL DERANGEMENTS OF THE TEMPOROMANDIBULAR JOINT – A RANDOMIZED CONTROLLED TRIAL

Army Dental Center Research and Referral1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年1月2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
30
试验地点
1
主要终点
3.Improvement in mouth opening.

研究概览

简要总结

Temporomandibular joint disorder (TMD) is a common source of orofacial pain and is characterized by pain, joint noise, limited range of motion, impaired jaw function, deviation or deflection upon mouth opening, malocclusion and closed or open locking. The term temporomandibular joint (TMJ) internal derangement is used synonymously to describe displacement of the articular disc. Though there are many conservative as well as surgical modalities available for management of TMD, only a few have been proved foolproof. The primary goals of the treatment for TMD are pain relief and increasing the range of mandibular motion. The milestone in the treatment of TMJ internal derangement was with the introduction of TMJ arthroscopy and methods for lysis and lavage of the upper joint space by arthrocentesis.

The lavage and lysis of the upper joint compartment under local anesthesia enables the disc to slide to its normal anatomic position, thus re-establishing the normal range of mandibular functions. Intra-articular administration of medications is an established method of treatment, particularly for rheumatic disorders that are associated with pain, effusion, inflammation of cartilage, bone and joint capsules as well as fibrous adhesions.

The aim of this prospective study is to compare the efficacy of arthrocentesis followed by intra-articular administration of PRP vs arthrocentesis followed by intra-articular administration of hyaluronic acid in patients with anterior disc displacement of the TMJ with or without reduction in order to minimize the symptoms which were unresponsive to conservative treatment modalities.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Outcome Assessor Blinded

入排标准

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

入选标准

  • 1.Patients with symptomatic TMD’s categorized under Wilkes classification Type II.
  • disc displacement with reduction and intermittent locking and Wilkes Type III.
  • acute disc displacement without reduction. 2.Poor prognosis to conservative management. 3.Patients giving consent for the study.

排除标准

  • 1.Patient with any previous invasive procedures on TMJ.
  • 2.Patient with inflammatory or connective tissue diseases.
  • 3.Any bony pathology associated with TMJ.
  • 4.Direct trauma to or fracture of facial bones involving the condyle.
  • 5.Allergic to local or topical anesthetics.
  • 6.Patients undergoing psychiatric treatment.
  • 7.Patients undergoing orthodontic treatment and orthognathic procedures.

结局指标

主要结局

3.Improvement in mouth opening.

时间窗: Follow-up will be done at 1 week, 1 month, 3 months and 6 months and data will be collected

4.Improvement in other possible excursive movements of the mandible.

时间窗: Follow-up will be done at 1 week, 1 month, 3 months and 6 months and data will be collected

1.Reduction of pain

时间窗: Follow-up will be done at 1 week, 1 month, 3 months and 6 months and data will be collected

2.Reduction of joint sounds.

时间窗: Follow-up will be done at 1 week, 1 month, 3 months and 6 months and data will be collected

次要结局

未报告次要终点

研究者

发起方
Army Dental Center Research and Referral
申办方类型
Research institution and hospital

研究点 (1)

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