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OpenTrials
Completed

NCT Number: NCT05536765

Augmented Reality in Oral Surgery

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.

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Key information

Age range

15 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Giuseppe D'Albis

Mola di Bari, Bari, 70042, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical exposure of impacted tooth

Procedure

The therapeutic approach of surgical exposure of impacted teeth is performed by preparing a flap and removing the cortical bone around the crown of the teeth.

This procedure provides optimal conditions for the orthodontist. In fact, surgical exposure allows the orthodontist to bond the impacted tooth in the correct position depending on the intended direction to apply the correct traction forces for alignment.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

D'Albis Dental

Other

Registry information

Official study title

Augmented Reality-assisted Surgical Exposure of an Impacted Tooth

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 13, 2022
Registry last updated
Sep 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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