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临床试验/NCT05536765
NCT05536765已完成不适用

Augmented Reality-assisted Surgical Exposure of an Impacted Tooth

D'Albis Dental1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2022年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1
试验地点
1
主要终点
Evaluation in mm of the superimposition between 3d model and patient anatomicals structures.

研究概览

简要总结

A digital workflow was used to assist the oral surgeon in pre-orthodontic exposure of a vestibular impacted canine using Augmented Reality.

Through software for the Object Recognition and Tracking, the researchers expand reality with cone beam computer tomography digital contents to optimize the outcome of surgery. The real-time video frames of the operating field aligned with the three-dimension file of the impacted tooth, were used as a guide to evaluate the surgical access to perform a minimally invasive flap and osteotomy.

详细描述

This study evaluate an AR-assisted approach for surgical exposure of a maxillary impacted canine. The usual protocol is the following:

  • Maxillary arches were scanned, and their occlusal relationship was registered using an optical intraoral scanner.The file was exported in Polygon File Format (PLY)
  • Using open-source CAD software, the part of the upper arch was selected from the first premolar to the other first premolars The teeth, the incisal edges and the cusps of the anterior sector were the anatomical markers required to match the patient's mouth and perform the object recognition.To this file that corresponded faithfully to reality we added the digital information required, that is, the position of the impacted crown of the canine
  • From the maxillary CBCT, DICOM files were imported in open-source medical software for segmentation and exportation of an STL file of the area of interest
  • Two 3D files obtained were imported into a CAD-CAM design software for superimposition. 3D file consisting of the intraoral scan plus the endosseous position of the crown of the impacted canine was exported
  • A full HD video camera was positioned in front of the patient's mouth, connected via an HDMI cable to a laptop
  • The AR software was then started, and the video camera was associated as an input source The software recognizes edges of files in images transmitted from the camera and overlap the object to the video images.

研究设计

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

入排标准

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

入选标准

  • Presence of an impacted tooth in aesthetic area
  • Good health according to the System of the American Society of Anesthesiology
  • No general medical contraindication for oral surgery
  • Good periodontal health

排除标准

  • Smoking more than 15 cigarettes a day • Untreated periodontitis
  • Pregnancy
  • Acute infections

结局指标

主要结局

Evaluation in mm of the superimposition between 3d model and patient anatomicals structures.

时间窗: 1 month

Evaluation of a software that uses algorithms to recognize and track 3D files in a real-time frame to visualize the endosseous position of the crown of an impacted tooth in order to plan the surgical exposure in a precise and minimally invasive manner. Evaluation through the software the distance in millimeters between the superimposition of the 3d model ed the patient's structures.

次要结局

未报告次要终点

研究者

发起方
D'Albis Dental
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giuseppe D'Albis

Principal Investigator

D'Albis Dental

研究点 (1)

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