跳至主要内容
临床试验/NCT04933409
NCT04933409Unknown不适用

3D Printed Donor Tooth Replica in Autotransplantation of Teeth. A Randomized Clinical Trial.

College of Medical Sciences Teaching Hospital. Nepal0 个研究点目标入组 50 人开始时间: 2021年10月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
主要终点
Operative time

研究概览

简要总结

3D printed replicas of the donor tooth can reduce extraoral time during the autotransplantation of teeth, which can reduce dehydration and manipulation of periodontal tissue of the donor tooth, thus possibly increasing the success rate.

详细描述

This technique of autotransplantation has been innovated using 3-dimensional (3D) imaging and rapid prototyping.The use of a 3D-printed replica of the donor tooth is thought to minimize the risk of iatrogenic damage to the actual donor tooth. Nevertheless, no large prospective and comparative studies are available to assess the outcomes using these 3D techniques. Therefore, this study aimed to compare 3D printed replicas in autotransplantation of teeth, compared to the conventional technique. The present study will evaluate the feasibility, clinical satisfied accuracy, and stability of a novel approach for computer-aided autotransplantation of teeth. This new approach facilitated the surgical procedure and might be a viable and predictable method for autotransplantation of teeth.

Application of printed 3D replicas of transplanted teeth facilitates surgical preparation of the recipient site, shortens the extra-alveolar time, and reduces the minimum the number of attempts of the donor tooth insertion at the prepared socket. Their use can significantly decrease the risk of damage to the root surface of a transplant, thus increasing the chance of success.

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
Single (Outcomes Assessor)

盲法说明

The outcomes will be evaluated by a blinded researcher.

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • patient presenting with decayed first molars
  • autotransplantation of third molar at the recipient site

排除标准

  • Diabetic, pregnant patients
  • other autotransplantations (other than first molar recipient and third molar donor)

结局指标

主要结局

Operative time

时间窗: 1 day

Operative time from the start of socket preparation at the recipient site

Rate of Ankylosis (replacement resorption)

时间窗: 6 months

Ankylosis (replacement resorption)

Rate of root resorption

时间窗: 6 months

infection related root resorption

Number of teeth that fail

时间窗: two weeks

reduced mobility (less than grade II) after 2 weeks of autotransplantation

次要结局

  • Cost difference of the treatment(1 day)

研究者

发起方
College of Medical Sciences Teaching Hospital. Nepal
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ashutosh Kumar Singh

Assistant Professor

College of Medical Sciences Teaching Hospital. Nepal

相似试验