跳至主要内容
临床试验/CTRI/2024/05/067932
CTRI/2024/05/067932尚未招募2/3 期

Evaluation of arthrocentesis using 3d printed guide versus conventional arthrocentesis in the treatment of internal derangement with reduction of temporomandibular joint– A Randomised control trial

Dr Sandhya kokitkar1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2024年6月7日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
14
试验地点
1
主要终点
Decrease the number of attempts thus avoiding multiple punctures,

研究概览

简要总结

EVALUATION OF THE EFFICACY OF ARTHROCENTESIS USING PATIENT SPECIFIC GUIDE IN THE TREATMENT OF INTERNAL DERANGEMENT WITH REDUCTION OF TEMPOROMANDIBULAR JOINT - A COMPARATIVE STUDY.

The temporomandibular joint (TMJ) forms one of the most fascinating and complex synovial joints in the body. Temporomandibular disorders (TMDs) are defined as clinical problems involving the masticatory musculature and the TMJ associated structures or both. Treatment strategy for TMDs consists of various nonsurgical and surgical methods. Arthrocentesis of TMJ has emerged over the years as a useful technique to manage TMDs.

Arthrocentesis, a simple minimally invasive technique is generally suggested in patients irresponsive to conservative therapies. Arthrocentesis requires experienced hand and takes multiple punctures to enter the joint space with subsequent post-operative discomfort and probability for facial nerve injury.

Thus, to overcome the shortcomings of manual arthrocentesis 3d printed guides has been designed with help of ct scan. Patient with internal derangement of TMJ with reduction of disc between age of 21 to 60 years will be included in the study. Efficacy of these guides will be compared with manual arthrocentesis by comparing Time required for procedure, Number of attempts required to insert needle into superior space, Patients discomfort during procedure, Post operative pain, Maximal Mouth opening, Presence of joint sound, Postoperative complications, Cost effectiveness.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • 1.Patient with internal derangement of TMJ with reduction of disc 2.Patients not responding to conservative therapy (Diet, pharmacotherapy, physical therapy, behavioural therapy, occlusal therapy) 3.Patients who are willing to participate in the study.
  • 4.Patients with ASA I and ASA II.

排除标准

  • 1.Patients with degenerative disorders of joint.
  • 3.rheumatoid arthritis/psoriatic arthritis 4.Patients with tenderness of TMJ secondary to myalgias or MPDS 5.Patient with history of Condylar fracture 6.Patient with excessive adipose tissue in facial region which will interfere with proper placement of patient specific guides.
  • Patients with severe systemic conditions.
  • (ASA III And ASA IV) 8.Pregnant and lactating patient.
  • 9.Patient with previous history of TMJ arthrocentesis, arthroscopy or surgery.

结局指标

主要结局

Decrease the number of attempts thus avoiding multiple punctures,

时间窗: outcomes will assisted intraoperatively,7th day, 1st month,3months 6months postoperative.

Minimal damage to TMJ and surrounding structures, Bridge the gap between arthroscopy and arthrocentesis

时间窗: outcomes will assisted intraoperatively,7th day, 1st month,3months 6months postoperative.

次要结局

  • complications of arthrocentesis using both technique(outcomes will assisted intraoperatively,7th day, 1st month,3months 6months postoperative.)

研究者

发起方
Dr Sandhya kokitkar
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Sandhya Kokitkar

Government Dental college and Hospital Mumbai

研究点 (1)

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