Assessment of the Artifical Intelligence Assisted Registration Versus Conventional Point Based Registration on Cone Beam-computed Tomography (CBCT) With Heavy Metal Artifacts

February 14, 2024 updated by: Nehal Ibrahim Ahmed Shobair, Ain Shams University

Assessment of the AI-assisted Registration Versus Conventional Point-based Registration on CBCTs With Heavy Metal Artifacts

Our study investigates the accuracy and duration needed for 3D model registration using artifical intelligence (AI) assistance compared to conventional point-based registration. Manual segmentation of all cone beam computed tomography (CBCT) scans will be performed before the registration procedure.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

CBCT images and intraoral scans will be screened following specific eligibility criteria. 16 CBCT images and intraoral scans that will meet the inclusion criteria will undergo manual segmentation via 3D medical image processing software. Afterward, point-based registration and AI-assisted registration will be performed by a single operator using specialized implant planning software. Then, the registration accuracy will be examined by measuring the distances between the three-dimensional models of CBCT data and intraoral scans. Also, the duration required for registration will be calibrated and recorded by a stopwatch.

Study Type

Interventional

Enrollment (Estimated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Private maxillofacial digital lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

CBCT scans for either the maxilla or mandible or both and intraoral scans or manual impressions with metal restorations.

Exclusion Criteria:

Scans without metal restorations.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AI-assisted registration
3D model registration will be carried out using artificial intelligence
Other: AI-assisted registration
We will use artificial intelligence to register 3d model on intra-oral scan
Active Comparator: Point-based registration
3D model registration will be carried out using point-based approach
Other: Point-based registration
We will use five references points or more to perform model registration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Registration accuracy
Time Frame: immediately after the procedure
Distance between registered 3d model and CBCT in millimeters
immediately after the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration for registration
Time Frame: During the procedure
time taken for registration procedure
During the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2023

Primary Completion (Actual)

January 20, 2024

Study Completion (Estimated)

February 25, 2024

Study Registration Dates

First Submitted

February 5, 2024

First Submitted That Met QC Criteria

February 14, 2024

First Posted (Actual)

February 22, 2024

Study Record Updates

Last Update Posted (Actual)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AI surgery protocol

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

no data will be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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