Evaluation of Pterygomaxillary Disjunction With Interpositional Y-shape Plate as an Innovative Minimally Invasive Technique in Patients With Temporomandibular Joint Internal Derangement (Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in wound healing
研究概览
简要总结
Temporomandibular joint internal derangement (TMJ ID) is the most frequent type of temporomandibular disorder (TMDs)which is managed by different therapeutic modalities. it begins with conservative methods like medical treatment, physiotherapy, thermotherapy, and bites appliance therapy. Surgical intervention is a controversial issue in cases not responding to conservative methods. A novel minimally invasive surgical technique which is extracapsular trans oral (Pterygomaxillary disjunction) has been advocated as a minimally invasive extracapsular technique that preserves TMJ integrity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients without relevant disease
- •Patients refractory to conservative treatment > 6 months.
- •Patients are diagnosed, with unilateral/bilateral anterior disc displacement without reduction, clinically and by MRI recently.
- •No previous TMJ surgery.
- •No previous maxillofacial trauma.
排除标准
- •Patients with systemic joint disease (rheumatoid, osteoarthritis, gouts).
- •Medically compromised patients contraindicating operation.
- •Patients to whom general anesthesia is contraindicated.
- •Patient with neuromuscular disorders.
- •Patients with any gross pathology of the ear.
- •Patient with psychoneurotic disorders.
结局指标
主要结局
Change in wound healing
时间窗: 1st week and 2nd week
The sutured wounds will be examined after one and two weeks for signs and symptoms of infection including swelling, redness, hotness, pus discharge, and pain in addition to observation for any manifestations of wound healing disturbance, as wound dehiscence and hardware exposure.
Change in TMJ clinical dysfunction
时间窗: 1st week, 2nd week, 1 month, and 3 months
Helkimo's dysfunction index is used, including the interincisal opening of the mandible, deviation during the opening, dysfunction of TMJ, pain in the TMJ and preauricular region, and also masticatory muscles were palpated for pain during the follow-up periods.
disc position
时间窗: at 3 months
MRI assessment by proton-density (PD), Evaluation by MRI will be done after 3 months to assure disc position.
次要结局
未报告次要终点
研究者
Hams Hamed Abdelrahman
Assistant lecturer of DPH and Clinical statistician
Alexandria University