跳至主要内容
临床试验/NCT03845088
NCT03845088招募中不适用

Application of Virtual Mandibular Position in Temporomandibular Jont Reconstruction With Costochondral Graft in Children Jaw Deformity.

Peking University1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2018年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
15
试验地点
1
主要终点
Bilateral ramus height,chin deviation,maxilla height 6 months after operation

研究概览

简要总结

Hypothesis:Computer-aided design virtual mandibular position is feasible for costochondral graft growing and occlusion stabilizing in the one-stage treatment of children temporomandibular joint ankylosis (TMJA) or condyle absence with jaw deformity.

Methods: The inclusion criteria is children patients younger than 12 years old with unilateral TMJA or condyle absence. A virtual mandibular position is designed preoperatively according to the CT data of jaw and dentition. 3D printed templates and occlusal splints are used to guide the costochondral graft and mandibular position. During surgery, the affected ramus is reconstructed with costochondral grafting under the virtual mandibular position. After surgery, the occlusal splint is fixed to maxilla at least one month, and then, replaced by orthodontic functional appliance to promote downward growth of the maxilla. Occlusion, facial symmetry, costochondral graft growing would be evaluated and analysed until adulthood.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • <12 years old
  • Unilateral temporomandibular joint ankylosis or condyle absence;
  • Temporomandibular joint reconstructed with costochondral graft;

排除标准

  • Bilateral temporomandibular joint ankylosis or condyle absence
  • Combined with systematic disease

结局指标

主要结局

Bilateral ramus height,chin deviation,maxilla height 6 months after operation

时间窗: 6 months after operation

Bilateral ramus height,chin deviation,maxilla height in millimeter 6 months after operation. These measurements were accomplished by ProPlan 2.0( SynthesProPlan,Materialise,Belgium)

Bilateral ramus height,chin deviation,maxilla height 12 months after operation.

时间窗: 12 months after operation

Bilateral ramus height,chin deviation,maxilla height in millimeter 12 months after operation.These measurements were accomplished by ProPlan 2.0( SynthesProPlan,Materialise,Belgium)

Bilateral ramus height,chin deviation,maxilla height

时间窗: preoperation

Bilateral ramus height,chin deviation,maxilla height in millimeter. These measurements were accomplished by ProPlan 2.0( SynthesProPlan,Materialise,Belgium)

次要结局

未报告次要终点

研究者

发起方
Peking University
申办方类型
Other
责任方
Principal Investigator
主要研究者

shuo chen

Attending Doctor

Peking University

研究点 (1)

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