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临床试验/NCT01903512
NCT01903512已完成不适用

Arthrocentesis and Temporomandibular Joint Disorders a Conservative Alternative to Surgical Treatments

Università degli Studi di Sassari1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2010年11月最近更新:
适应症

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
Pain decrease

研究概览

简要总结

This study aims to evaluate the efficacy of arthrocentesis in the treatment of internal derangement of the temporomandibular joint (TMJ).

详细描述

This work was designed as a prospective case series clinical study. Patients imaging was evaluated with Cone-Beam Computed Tomography and Nuclear Magnetic Resonance at the beginning of the treatment and after the last arthrocentesis.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
25 Years 至 62 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • TMJ noises and click
  • history of unsuccessful conservative management (NSAID and occlusal bite)
  • occlusal bite still present

排除标准

  • degenerative joint disease (such as osteoarthritis, rheumatoid arthritis etc.)
  • history of condylar fractures or previous TMJ trauma
  • TMJ surgery

结局指标

主要结局

Pain decrease

时间窗: baseline (preop), 1 week, 1 month, 2 months, 6 months, 12 months (postop)

Patients were followed up for 1 year. The mean pre-operative pain, using visual analog scale, showed an average decrease of 6.7 at 1 year.

increase in the mouth opening

时间窗: Baseline (preop), 1 week, 1 month, 2 months, 6 months, 12 months (postop)

The mean maximum mouth opening(MMO) pre-operatively was 15,8 mm and increased to 34 mm immediately following arthrocentesis which increased by 0.5-1 mm at every month followup with mean MMO of 39,4 mm at 6 months. Thereafter it remained consistent till 1 year. The mean increase in the mouth opening at 1 year was 23,6 mm

TMJ click and noises reduction

时间窗: Baseline (preop), 12 months (postop)

At the end of 1 year, (75%) patients stated no evidence of clicking.

次要结局

  • number of subjects showing signs of TMJ inflammation or structural alterations at Magnetic Resonance Imaging and Cone Beam Computerized Tomography pre- and postop.(Baseline (preop)- 60 days postop)

研究者

发起方
Università degli Studi di Sassari
申办方类型
Other
责任方
Principal Investigator
主要研究者

Silvio Mario Meloni

DDS, PhD, Assistant Professor

Università degli Studi di Sassari

研究点 (1)

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