Ultrasound Guided Versus Conventional Arthrocentesis in Treatment of Temporomandibular Joint Internal Derangement: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 34
- 主要终点
- Maximum mouth opening
研究概览
简要总结
The use of Ultrasound as a guide in arthrocentesis of tempromandibular joint versus conventional anatomically guided arthrocentesis in treatment of temporomandibular joint internal derangement: A randomized clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 16 to 45 years of age having temporomandibular joint internal derangement.
- •Patients free from any systemic conditions and bone metabolic diseases that might interfere with the surgical intervention, soft tissue or hard tissue healing.
- •ASA 1-2 patients with no contraindications for GA
- •Patients who did not respond to conservative treatment.
排除标准
- •Patient with uncontrolled systemic diseases precluding administration of general anesthesia.
- •Handicaps and special needs patients.
- •Prisoners.
研究组 & 干预措施
Conventional arthrocentesis
- Scrubbing and draping of the patient will be carried out in a standard fashion using betadine surgical scrub.
- Head turned to the affected side.
- External auditory meatus will be blocked with a cotton plug.
- A line will be drawn from tragus of the ear to the outer canthus of the eye with ink.
- Double needled canula is inserted into superior compartment of the joint space 2mm below and 10 mm ahead of mid-tragal end of Holmund Hellsing's line.
Intra-operative procedures - continued in both groups:
- Lavage is performed with 100 ml of saline solution.
- 1 ml of Hyaluronic acid is injected into the superior joint space.
- Puncture point is covered with sterile dressing for 24 hours
干预措施: Conventional anatomically guided arthrocentesis of tempromandibular joint (Procedure)
Ultrasound guided arthrocentesis
Scrubbing and draping of the patient will be carried out in a standard fashion using betadine surgical scrub.
- Head turned to the affected side.
- External auditory meatus will be blocked with a cotton plug.
- Transducer is placed over TMJ, parallel to the long axis of mandibular ramus. • Transducer is tilted until the optimal visualization is obtained.
- Disc is visualized as a thin homogenous, hypo-to-iso-echoic band lying adjacent to the inferior relation. The bony landmarks of the mandibular condyle and the articular eminence are visualized as hyperdense lines.
- Superior joint space located between the disc and articular eminence is the targeted point of the needle.
Intra-operative procedures - continued in both groups:
- Lavage is performed with 100 ml of saline solution.
- 1 ml of Hyaluronic acid is injected into the superior joint space.
- Puncture point is covered with sterile dressing for 24 hours
干预措施: Ultrasound guided arthrocentesis of tempromandibular joint (Procedure)
结局指标
主要结局
Maximum mouth opening
时间窗: Patients will be evaluated after 2 weeks from operation and every 2 weeks thereafter for the next 3 months.
Maximum mouth opening of the patient will be measured in Millimetre (mm) using a ruler
Joint pain
时间窗: Patients will be evaluated after 2 weeks from operation and every 2 weeks thereafter for the next 3 months.
Joint pain: Will be measured by visual analogue scale (VAS) of 10 units according to pre-determined reference values: 0 No pain. 1-2 Faint pain. 3-4 Mild pain 5-6 Moderate pain. 7-8 Severe pain. 9-10 Excruciating pain.
次要结局
- Operation time(Once during every procedure)
研究者
Samiha Abdelsalam Abdelaziz Abdelaziz
Principal investigator
Cairo University