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NCT Number: NCT06945692

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

patient specific reconstruction plates

Procedure

Use of patient specific reconstruction plates on the 3-D virtually-generated defect using Artificial Intelligence.

Primary outcomes

  1. 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

  2. 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)

Secondary outcomes

  1. Aethetic outcome

    Time frame: baseline

    The measuring device is Facial appearance using a 4-point score

  2. Occlusion

    Time frame: baseline

    The measuring device is Digital occlusion analysis using T-scan and the unit is percentage

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah Moustafa. Moustafa, MSc.

CONTACT

[email protected]

56794540

Sarah Moustafa. Moustafa, PHD

CONTACT

[email protected]

01006133135

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 25, 2025
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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