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临床试验/NCT02464202
NCT02464202已完成不适用

Use of Stereolithographic Model in Tooth Autotransplantation and Periodontal Ligament Stem Cells for Pulp Revascularization and Reinnervation to Increase the Success Rate for Tooth Replacement in Children

Universitaire Ziekenhuizen KU Leuven2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年5月1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
100
试验地点
2
主要终点
survival rate

研究概览

简要总结

The aim of this study lies in comparing the outcome of the proposed technique in a large sample size group to the outcome of the conventional tooth autotransplantation method and to provide sufficient evidence for improving the long-term success rate of the tooth autotransplantation procedure.

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
9 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • The subjects will be divided in two groups according to different surgical protocols.
  • Pediatric subjects (age between 9-18 years) treated with the CBCT-based replica procedure (prospective approach).
  • Pediatric subjects (N=50) that missed their teeth due to agenesis or lost their permanent teeth due to trauma, caries, and endodontic failure and referred to dentistry department for replacement of the missing tooth by means of tooth autotransplantation.
  • Pediatric subjects (age between 9-18 years) treated with the conventional method (prospective and retrospective).
  • Pediatric subjects (N=50) that missed their teeth due to agenesis or lost their permanent teeth due to trauma, caries, and endodontic failure and referred to dentistry department for replacement of the missing tooth by means of tooth autotransplantation.
  • A matched control patient will be selected with the focus on a very similar surgical challenge, based on age, gender and a matching donor tooth with the same stage of root development and host bed.

排除标准

  • Potential participants (case and control) will be excluded if follow-up data are missing for the one-year follow-up.

结局指标

主要结局

survival rate

时间窗: 5 years

success rate

时间窗: 5 years

次要结局

未报告次要终点

研究者

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

Reinhilde Jacobs

Prof. Dr.

Universitaire Ziekenhuizen KU Leuven

研究点 (2)

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