Impacted ToothNCT05536765
Augmented Reality in Oral Surgery
An observational study of Impacted Tooth, run by D'Albis Dental at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Impacted Tooth
- What is being tested?
- Surgical exposure of impacted tooth
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2022to 1 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with impactet tooth. In growing age or not.
Who may be able to join
- 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
Who cannot join
- Smoking more than 15 cigarettes a day • Untreated periodontitis
- Pregnancy
- Acute infections
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Impacted Tooth
- Being tested
- Surgical exposure of impacted tooth
- Keywords
- Augmented reality, Oral Surgery, Computer guided surgery, Computer assisted surgery
- Medical subject headings
- Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical exposure of impacted toothProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with impacted tooth | Not described Receives: Procedure: Surgical exposure of impacted tooth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation in mm of the superimposition between 3d model and patient anatomicals structures.
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start1 Feb 2022
- Primary completion1 Jul 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impacted ToothStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- D'Albis Dental
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe D'Albis, D'Albis Dental
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05536765
- Sponsor's protocol ID
- AR in Dentistry
- Status last verified
- Jun 2022
- First submitted
- 6 Sep 2022
- Last updated
- 13 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmented Reality-assisted Surgical Exposure of an Impacted Tooth
- ClinicalTrials.gov ID
- NCT05536765
- Acronym / sponsor ID
- AR in Dentistry
- Conditions
- Impacted Tooth
- Keywords
- Augmented reality, Oral Surgery, Computer guided surgery, Computer assisted surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- D'Albis DentalUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 13 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with impacted tooth | – | Procedure: Surgical exposure of impacted tooth |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with impactet tooth. In growing age or not.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Smoking more than 15 cigarettes a day • Untreated periodontitis
- Pregnancy
- Acute infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical exposure of impacted toothThe 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. | Procedure or surgery | Patients with impacted tooth |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Impacted Tooth, run by D'Albis Dental at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation in mm of the superimposition between 3d model and patient anatomicals structures. (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2022.