Clinical trial NCT05536765: Augmented Reality in Oral Surgery
Official title: Augmented Reality-assisted Surgical Exposure of an Impacted Tooth
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Impacted Tooth
Keywords: Augmented reality
Oral Surgery
Computer guided surgery
Computer assisted surgery
Lead sponsor: D'Albis Dental
Sponsor class: OTHER
First posted: 2022-09-13
Enrollment: 1
Sex: ALL
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with impactet tooth. In growing age or not.

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.

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

Primary outcomes:
measure: Evaluation in mm of the superimposition between 3d model and patient anatomicals structures.
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Mola di Bari
country: Italy
facility: Giuseppe D'Albis
state: Bari
Study officials:
References: