Actively Recruiting

Age: 18Years - 50Years
All Genders
NCT06893614

Facial Conformation Meshes for Orthognathic Surgery

Led by Ain Shams University · Updated on 2025-03-25

13

Participants Needed

2

Research Sites

7 weeks

Total Duration

On this page

Sponsors

A

Ain Shams University

Lead Sponsor

M

Misr International University

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study is a retrospective analysis that evaluates the accuracy of 3D soft tissue simulation in bimaxillary orthognathic surgery for Class III dentofacial deformities. The study integrates segmented 3D facial conformation meshes and regional aesthetic subunits to enhance soft tissue prediction accuracy. Key Aspects of the Study: Study Design: Retrospective analysis based on existing CBCT scans of patients who have undergone maxillary advancement and mandibular setback surgery. Objective: To assess the accuracy of soft tissue predictions using Dolphin software in different facial regions, particularly in midline vs. lateral regions. Methodology: .CBCT superimposition using voxel-based registration. .Soft tissue surface analysis via generic mesh conformation and dense correspondence analysis. .Error assessment in X, Y, Z dimensions rather than Euclidean distance. .Color-coded maps for visualizing prediction accuracy. Clinical Relevance: The study aims to refine 3D prediction models for orthognathic surgery planning, making them more precise and reliable. Key innovation: Modifying the aesthetic unit segmentation approach for a clinically and statistically relevant assessment of soft tissue changes. Findings will contribute to improving surgical outcome predictability and optimizing treatment planning in maxillofacial surgery. Ethical Considerations: No patient recruitment; the study relies solely on existing anonymized CBCT scans. Ethical approval and waiver of informed consent will be sought from the Institutional Review Board (IRB). This research aligns with modern advancements in 3D facial prediction technology, aiming to enhance precision and clinical applicability in orthognathic surgery.

CONDITIONS

Official Title

Facial Conformation Meshes for Orthognathic Surgery

Who Can Participate

Age: 18Years - 50Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with preoperative and at least 6 months postoperative CBCT scans
  • Patients with Class III facial deformity
  • Patients who underwent bimaxillary orthognathic surgery with maxillary advancement and mandibular setback
Not Eligible

You will not qualify if you...

  • CBCT scans of patients with craniofacial anomalies including cleft lip or palate
  • Patients who had previous maxillofacial surgeries or facial scars
  • Patients who had multi-segment Le Fort I osteotomies
  • Patients who had simultaneous genioplasty as part of their correction
  • Patients with significant facial asymmetry
  • Patients with missing data

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Ain Shams University

Cairo, Abbassia, Egypt, 11566

Actively Recruiting

2

Ain Shams University

Abbassia, Cairo Governorate, Egypt, 11566

Actively Recruiting

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Research Team

N

Nehal I Shobair, PhD

CONTACT

Y

Yassin S Alian, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Facial Conformation Meshes for Orthognathic Surgery | DecenTrialz