Facial Conformation Meshes for Orthognathic Surgery

NCT06893614 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 13

Last updated 2025-03-25

No results posted yet for this study

Summary

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

  • Orthognathic Surgical Procedures

Sponsors & Collaborators

  • Misr International University

    collaborator OTHER
  • University of Glasgow

    collaborator OTHER
  • Cairo University

    collaborator OTHER
  • Ain Shams University

    lead OTHER

Principal Investigators

  • Ashraf F Ayoub, Professor · Department of Oral and Maxillofacial Surgery, School of Medicine, Dentistry & Nursing, Glasgow Dental Hospital & School, Glasgow, United Kingdom.

  • Mohammed Diaa Zain El Abedeen, Professor · Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Ain Shams University, Cairo, Egypt

  • Nehal I Shobair, Lecturer · Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Misr International University, Cairo, Egypt

  • Xiangyang Ju, Head of Image Processing · Medical Devices Unit, NHS Greater Glasgow and Clyde, Glasgow, United Kingdom

  • Amr A Ghanem, Professor · Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Ain Shams University, Cairo, Egypt

  • Amr M Ekram, Consultant · Department of Oral and Maxillofacial Surgery, Faculty of Oral and Dental Medicine, Cairo University

  • Ahmed Barakat, Professor · Department of Oral and Maxillofacial Surgery, Faculty of Oral and Dental Medicine, Cairo University

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-12
Primary Completion
2025-04-15
Completion
2025-05-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06893614 on ClinicalTrials.gov