Evaluation of Using Patient Specific Zirconium Dioxide Implant Versus Patient Specific Titanium Implant in Treatment of Chronic Condylar Dislocation. A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 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
Alternate hypothesis that treatment of Tempromandibular joint dislocation with Zirconium Dioxide eminoplasty will be more efficient than using titanium onlays in terms of decreasing maximum inter incisal distance and providing better soft tissue response and post-operative patient satisfaction.
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
- 是
入选标准
- •Patient with recurrent dislocation with maximum inter incisal opening over 55mm
- •Long-standing dislocation of the TMJ involving both fixation for more than 3 weeks and the failure of manual reduction
- •Failure of conservative strategies such as orientation to self-limit jaw movement and the use of a chin-cap or bandage
- •Both sexes
- •Age between 18 and 48 years.
- •Highly motivated patients.
排除标准
- •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 Titanium onlay implant
干预措施: eminoplasty with patient specific Zirconium dioxide onlay implant (Device)
eminoplasty with patient specific zirconium dioxide onlay implant
干预措施: eminoplasty with patient specific Zirconium dioxide 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 the difference between preoperative and postoperative Maximal interincisal opening is recorded (mm)
次要结局
- Patient's Pain(6 months)
研究者
Adham Zakaria
Teaching Assistant at Oral and Maxillofacial Sugery department, Faculty of dentistry
Cairo University