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Clinical Trials/NCT05536765
NCT05536765
Completed
Not Applicable

Augmented Reality-assisted Surgical Exposure of an Impacted Tooth

D'Albis Dental1 site in 1 country1 target enrollmentFebruary 1, 2022
ConditionsImpacted Tooth

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Impacted Tooth
Sponsor
D'Albis Dental
Enrollment
1
Locations
1
Primary Endpoint
Evaluation in mm of the superimposition between 3d model and patient anatomicals structures.
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2022
End Date
August 1, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
D'Albis Dental
Responsible Party
Principal Investigator
Principal Investigator

Giuseppe D'Albis

Principal Investigator

D'Albis Dental

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 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.

Study Sites (1)

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