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临床试验/NCT05983718
NCT05983718招募中不适用

Comparison of Positional Accuracy in Dental Implant Placement Between Conventionally Used Guide Pin and 3D Printed Surgical Guide Developed From CBCT

Dhaka Dental College and Hospital2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2023年8月23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
28
试验地点
2
主要终点
Angular deviation

研究概览

简要总结

This is a randomized controlled study that aims to compare the accuracy between full-guided with guide-pin-assisted free-hand dental implant surgeries. The basis of evaluation in each case is the comparison of the preoperative digital plan with the actual postoperative status.

详细描述

Dental implant surgery is a treatment that replaces damaged or missing teeth with artificial teeth that are aesthetically and functionally similar to natural teeth. For a successful implant surgery, it is necessary to use digital planning software in conjunction with a cone-beam CT scan and a custom-made 3D-printed surgical guide. In developing countries like Bangladesh, surgical guide-assisted dental implant surgery is absent. Doctors attend implant surgeries relying on their visual assessment from x-ray images or CBCT data. They need to cut the outer soft tissue, expose the bone, and use a guide pin to confirm the direction and location. Then they perform implant surgery following the hole created by the guide pin, similar to free-hand surgery. But the overall procedure is still highly invasive and has low accuracy.

Free-hand implant surgeries are still in practice everywhere. The application of a guide pin has been observed in some places to enhance the situation. A guide pin helps an operator recognize the position and angle of an alveolar bone when forming an implantation hole in the alveolar bone to insert an implant into the alveolar bone. Doctors insert a guide pin to the implant site with minimal incision and then confirm the desired direction and location with a radiographic image. However, we need a proper clinical evaluation to compare fully-guided surgeries to guide-pin-assisted surgeries to understand the accuracy of both processes.

The accuracy of the pre-planned 3D-printed surgical guide is well established. Introducing dental software and guided surgery has already achieved higher acceptance in implant surgery. Several patients from several privileged parts of the world benefit from surgical guides. But the usual design convention includes intraoral scanner data with CBCT. However, intraoral scanners are still unavailable in many dental hospitals. The study is designed to address the precision of dental implant surgeries worldwide, especially where the intraoral scanner is not present. In our research, we will focus on partially edentulous patients. And our design procedure will not be dependent on intra-oral scanner data. As partially edentulous patients are higher in number and CBCT machines readily available in hospitals, this study can open up a way to address the scarcity of intra-oral scanner data to avail a large number of implant patients with an effective guide. The success rate of this study will encourage us not only to prioritize guided surgeries over free-hand practices or guide-pin-assisted surgeries but also to significantly impact the execution of implant surgeries in developing countries.

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)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients of age between 18 to 75 and of any gender
  • Patient fit for implantation (satisfactory soft and hard tissue conditions and occlusion)
  • Partially edentulous patient

排除标准

  • Patient with pregnancy
  • Patient with uncontrolled diabetes mellitus.
  • Patient who needed dentoalveolar or associated soft tissue reconstruction procedure
  • Patient taking bisphosphonate or have any history of systemic or local bone disease
  • Recent extracted sites
  • Patients with a history of smoking, alcoholism
  • Patient with a history of head-neck radiation
  • Patient with associated periapical pathology or history of parafunctional habit
  • Patient needs bone grafting.
  • Known HIV, Hepatitis B, or Hepatitis C infection.
  • Limited mouth opening, which, in the examiner's opinion, would risk the success of the intervention
  • Local infection
  • Known allergy to any component of the implant or the implant guide

结局指标

主要结局

Angular deviation

时间窗: 3 months

The angle formed by the primary axis of the proposed digital implant and the actual implant as put, stated in degrees.

次要结局

  • Apical deviation(3 months)
  • Coronal deviation(3 months)

研究者

发起方
Dhaka Dental College and Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Md. Al-Amin Sarkar

Junior Consultant

Dhaka Dental College and Hospital

研究点 (2)

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