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临床试验/CTRI/2024/09/074037
CTRI/2024/09/074037
尚未招募
3 期

The efficacy of automatic arthrocentesis in TMJ disorders

Praveen KumarS1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年10月23日最近更新:

概览

阶段
3 期
状态
尚未招募
发起方
Praveen KumarS
入组人数
10
试验地点
1
主要终点
Pain relief

概览

简要总结

This study aims to find the efficacy of automated arthrocentresis in TMJ disorders patient. Surgical field should be isolated and cleaned using povidone iodine, specifically the ear and pre auricular region. External auditory canal should be conserved from fluid and stagnation of blood using cotton. The auriculotemporal nerve block should be given to joint penetrating region. The arthrocentresis technique described by NITZAN et. Al. will be used. A line should be drawn from the corner of the eye to tragus and the first mark will be made 10 mm from the tragus and 0.5mm below the line. The second point will be marked 20mm from the tragus and 1mm below the line a 21 - gauge needle will be inserted into the superior joint compartment from the first point and 5ml saline solution will be injected to widen the upper joint space. A second needle, the same diameter as the first, will be inserted second point and will be manually confirmed that upper joint space was irrigated effectively. The tube of the irrigation pump will be connected to second needle and automatic irrigation was initiated

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • Pain located in affected TMJ especially during opening Clicking sound Restricted mouth opening less than 35 mm with TMJ pain Difficulty in lateral movement towards the towards the unaffected side Deviation towards the affected side in opening and protrusion movements Patients who did not respond to conservative management including splint therapy.

排除标准

  • Patients suffering from any systemic diseases, platelets disorders, fibrinogen deficiency Patients with previous TMJ surgery Patients with previous joint fractures, infection Patients receiving anticoagulation treatment or non- steroidal anti-inflammatory drugs within 48 hours preoperatively.

结局指标

主要结局

Pain relief

时间窗: At baseline, 4 weeks, 3 months

Mouth opening

时间窗: At baseline, 4 weeks, 3 months

次要结局

  • Clicking sound(Jaw deviations)

研究者

发起方
Praveen KumarS
申办方类型
Other [Self ]
责任方
Principal Investigator
主要研究者

Praveen Kumar S

Sree Balaji dental college and hospital

研究点 (1)

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