Assessment of Accuracy and Aesthetics Following Automated Mandibular Defect Reconstruction Using AI

April 20, 2025 updated by: Sarah Moustafa Mahmoud Fahmy El-Youtti, Cairo University

Assessment of Accuracy and Aesthetics Following Automated Mandibular Defect Reconstruction Using Artificial Intelligence: A Case Series Study

The Aim of the study is to evaluate Accuracy of automated mandibular defect reconstruction using Artificial intelligence and assessing impact on aesthetic and occlusion outcomes using patient-specific reconstruction plates.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The digital surgical process often requires an expected mandibular reference model. Currently, the common digital surgery process, is to mirror repair or manually look for other similar mandibles for local data fusion and smoothing processing. A more accurate expected reference model is difficult to achieve, time consuming and difficult to promote in clinical practice. Moreover, rapid routing processing often has poor accuracy. For cumulative bilateral lesions, massive lesions, obvious displacement or lesions cross the middle line, there is still no effective method to predict the expected reference model in clinical practice.

The main objective for conducting this study is to propose an improved algorithm to overcome the drawbacks of recent studies using 3D Unet and to test the predictability and clinical value of virtually generated 3d models of defected mandible in real patients.

Study Type

Interventional

Enrollment (Estimated)

4

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 Contact

Study Contact Backup

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with mandibular tumors, cysts or any benign disease resulting in mandibular continuity defect.
  • Age group: from 18 - 55 years old.
  • No sex predilection.
  • CTs or CBCTs of only healthy mandibles from an online database and real data.

Exclusion Criteria:

  • Patients with mandibular malignant lesions.
  • Children age group from 2-17.
  • CTs Of maxilla.
  • Elderly patients to be excluded due to the normal physiologic bony change.

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient specific reconstruction plates
Patients with benign lesions indicated for resection and resulting in mandibular continuity defects treated with patient specific reconstruction plates.
Procedure: patient specific reconstruction plates
Use of patient specific reconstruction plates on the 3-D virtually-generated defect using Artificial Intelligence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy Of the virtually Generated 3D model using AI
Time Frame: baseline
The measuring device is the AI model using the Percentage as a unit
baseline
Accuracy of AI generated model clinically
Time Frame: baseline

The measuring device is by Superimposition of both virtual 3-d generated model and real patient CT post operative using software ( blender ) .

( Structural Similarity Index) (SSIM)
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aethetic outcome
Time Frame: baseline
The measuring device is Facial appearance using a 4-point score
baseline
Occlusion
Time Frame: baseline
The measuring device is Digital occlusion analysis using T-scan and the unit is percentage
baseline

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Principal Investigator: Sarah Moustafa, MSc., Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

May 1, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

April 10, 2025

First Submitted That Met QC Criteria

April 20, 2025

First Posted (Actual)

April 25, 2025

Study Record Updates

Last Update Posted (Actual)

April 25, 2025

Last Update Submitted That Met QC Criteria

April 20, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI in Mandibular Defects

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Mandibular Tumor

Clinical Trials on patient specific reconstruction plates

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe