- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05536765
Augmented Reality in Oral Surgery
Augmented Reality-assisted Surgical Exposure of an Impacted Tooth
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Bari
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Mola di Bari, Bari, Italy, 70042
- Giuseppe D'Albis
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with impacted tooth
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AR in Dentistry
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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