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临床试验/NCT05377593
NCT05377593已完成不适用

Evaluation of Using Patient Specific Zirconium Dioxide Implant Versus Patient Specific Titanium Implant in Treatment of Chronic Condylar Dislocation. A Randomized Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2022年3月23日最近更新:
适应症

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

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adham Zakaria

Teaching Assistant at Oral and Maxillofacial Sugery department, Faculty of dentistry

Cairo University

研究点 (1)

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