Evaluation of Using Patient Specific Ultra-High Molecular Weight Polyethylene Implant Versus Patient Specific Titanium Implant in Treatment of Chronic Condylar Dislocation A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Difference in maximal inter incisal distance between pre-operative and post-operative (mm)
研究概览
简要总结
Does patient specific Ultra-High Molecular Weight Polyethylene implant eminoplasty will decrease maximum interincisal distance, provide better soft tissue response and post-operative patient satisfaction than patient specific Titanium eminoplasty in treatment of chronic condylar dislocation?
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 48 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with recurrent dislocation with their maximum inter incisal opening over 55mm
- •longstanding dislocation of the TMJ involving both fixation for more than 3weeks and the failure of manual reduction
- •failure of conservative strategies such as orientation to self-limiting jaw movement and the use of chin-cap or bandage
排除标准
- •patients with post-menopausal females with osteoporosis
- •Patient with uncontrolled systemic disease
- •pregnancy
- •psychological disorders, drug or alcohol dependency
- •Known allergies or sensitivities to dental materials, including Zirconia, Titanium or general anesthetic agents
- •Inability to return for follow up visits.
- •Refusal of participation from the patient
研究组 & 干预措施
Eminoplasty with patient specific ultrahigh molecular weight polyethylene onlay implant
Eminoplasty will be done for patient with chronic condylar dislocation using specific ultrahigh molecular weight polyethylene implants
干预措施: Eminoplasty with patient specific ultrahigh molecular weight polyethylene onlay implant (Device)
eminoplasty with patient specific titanium onlay implant
eminoplasty with patient specific titanium onlay implant
干预措施: Eminoplasty with patient specific ultrahigh molecular weight polyethylene onlay implant (Device)
结局指标
主要结局
Difference in maximal inter incisal distance between pre-operative and post-operative (mm)
时间窗: 6 months
using a caliper difference between preoperative and postoperative maximal interincisal opening is recorded (mm)
次要结局
- patient pain(6 months)
研究者
Ahmed Tarek Taher Abd El Halim
Teaching Assistant at Oral and Maxillofacial Surgery department, Faculty of dentistry
Cairo University