Ultrasound -Guided Versus Conventional Non Guided Autologous Blood Injection For Treatment of Patients With Chronic Recurrent Temporomandibular Joint Dislocation. A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- maximum mouth opening
研究概览
简要总结
The aim of this study is To compare the accuracy and effectiveness of ultrasound (US) guided autologous blood injection (ABI) versus non- guided technique for the treatment of chronic recurrent temporomandibular joint dislocation
详细描述
All patients involved in this study will be divided randomly to two different groups and injected with autologous blood into joint space and pericapsular tissue.
Study group (group A) will be injected with autologous blood with ultrasound guidance.
control group (group B) will be injected with autologous blood without US guidance. Anatomical landmarks and tactical sense will be followed only.
The operation will be done under local anesthesia ( Auriculotemporal nerve block ) the skin overlying the temporomandibular joint will be scrubbed by an antiseptic solution and the area will be isolated with sterile towels. External auditory canal will be blocked with cotton.
About 3 ml of blood will be withdrawn from patient's antecubital fossa, of which 2 ml injected intra-articular and 1 ml in the pericapsular tissue (PT) The procedure should be repeated on the opposite side in case of bilateral involvement.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient with at least 3 episodes of temporomandibular joint dislocation in the past 6 months.
- •Necessitating a visit to the emergency room or trained professional to reduce the dislocation.
- •Radiological evidence of displacement of condylar head beyond the articular eminence on wide mouth opening.
- •Maximum mouth opening (MMO) more than 40 mm.
- •Unilateral or bilateral.
- •Over 18 years of age.
- •Both gender Males or females.
排除标准
- •Patient having inflammatory temporomandibular joint disease like tuberculous arthritis, rheumatoid arthritis.
- •Patients with bleeding disorders, pregnancy or bony pathology of temporomandibular joint .
- •Allergy to local anesthetic.
- •Severe epilepsy or Parkinson's disease.
- •Patient on anti-depressants or anti-psychotics.
- •Inability to follow-up the patient during the entire follow-up period.
- •Patients who had recent fracture at temporomandibular joint level or who had previous surgical interference to temporomandibular joint .
- •Refused to sign the written informed consent were also excluded.
结局指标
主要结局
maximum mouth opening
时间窗: at 2weeks, 3months and 6 months post-operative
change in Maximum mouth opening (MMO): It's measured (in millimeter) from incisal edge of 11 to 41, in maximum mouth open position using caliper
次要结局
- Frequency of temporomandibular joint dislocation:(2weeks, 3 months and 6 months post-operatively)
- change of pain(2weeks, 3 months and 6 months post-operatively)
研究者
Mohamed Abbas Morsy Hussien
principal investigator
Cairo University