NCT05536765

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 6, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 13, 2022

Completed
Last Updated

September 13, 2022

Status Verified

June 1, 2022

Enrollment Period

5 months

First QC Date

September 6, 2022

Last Update Submit

September 8, 2022

Conditions

Keywords

Augmented realityOral SurgeryComputer guided surgeryComputer assisted surgery

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 month

Study Arms (1)

Patients with impacted tooth

Procedure: Surgical exposure of impacted tooth

Interventions

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.

Patients with impacted tooth

Eligibility Criteria

Age15 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with impactet tooth. In growing age or not.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Giuseppe D'Albis

Mola di Bari, Bari, 70042, Italy

Location

MeSH Terms

Conditions

Tooth, Impacted

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 6, 2022

First Posted

September 13, 2022

Study Start

February 1, 2022

Primary Completion

July 1, 2022

Study Completion

August 1, 2022

Last Updated

September 13, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations