Facial Conformation Meshes for Orthognathic Surgery

NCT06893614 | Recruiting DMC

• 1 other identifier: Nehal Esthetic units
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Orthognathic Surgery; Three-Dimensional Imaging.; Soft Tissue.; Cone-Beam Computed Tomography; Prognathism; Treatment Outcome; Computer Simulation

Outcome Measures

Primary Outcomes (1)

• Prediction accuracy

  the accuracy of the software soft tissue simulation in response to bimaxillary surgery including maxillary advancement and mandibular setback will be measured comparing the stl if the actual patient soft tissue recorded at least 6 months postoperative versus the software prediction to the same surgical movement. the accuracy will be measured using facial conformation mesh for each esthetic unit. the outcome will be the mean of the linear discripance between the two stls for each facial esthetic region im millimeters.(mean discripancy for each esthetic unit in millimiters)

  1 month

Study Arms (1)

Class III Patients treated with bimaxillary surgery

Preoperative and at least 6 months postoperative CBCTs of Patients who suffered from class III facial deformity and had bimaxillary orthognathic surgical correction who undergone maxillary advancement and mandibular setbacks.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients who suffered from class III facial deformity and had bimaxillary orthognathic surgical correction who undergone maxillary advancement and mandibular setbacks.

You may qualify if:

• Preoperative and at least 6 months postoperative CBCTs of Patients who suffered from class III facial deformity and had bimaxillary orthognathic surgical correction who undergone maxillary advancement and mandibular setbacks.

You may not qualify if:

• CBCTs of patients with:
• Craniofacial anomalies including cleft lip/palate,
• who had had previous maxillofacial operations or facial scars,
• Surgical Corrections that required multi-segment Le Fort I osteotomies,
• Simultaneous Genioplasty as part of the carried-out corrections.
• Significant facial Asymmetry.
• Missing Data

Sponsors & Collaborators

• Ain Shams University: lead
• Misr International University: collaborator
• University of Glasgow: collaborator
• Cairo University: collaborator

Study Sites (2)

Ain Shams University

Cairo, Abbassia, 11566, Egypt

RECRUITING

Ain Shams University

Abbassia, Cairo Governorate, 11566, Egypt

RECRUITING

MeSH Terms

Conditions

Prognathism

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Mandibular Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ashraf F Ayoub, Professor

  Department of Oral and Maxillofacial Surgery, School of Medicine, Dentistry & Nursing, Glasgow Dental Hospital & School, Glasgow, United Kingdom.

  STUDY CHAIR

• Mohammed Diaa Zain El Abedeen, Professor

  Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Ain Shams University, Cairo, Egypt

  STUDY DIRECTOR

• Nehal I Shobair, Lecturer

  Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Misr International University, Cairo, Egypt

  PRINCIPAL INVESTIGATOR

• Xiangyang Ju, Head of Image Processing

  Medical Devices Unit, NHS Greater Glasgow and Clyde, Glasgow, United Kingdom

  STUDY DIRECTOR

• Amr A Ghanem, Professor

  Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Ain Shams University, Cairo, Egypt

  STUDY DIRECTOR

• Amr M Ekram, Consultant

  Department of Oral and Maxillofacial Surgery, Faculty of Oral and Dental Medicine, Cairo University

  STUDY DIRECTOR

• Ahmed Barakat, Professor

  Department of Oral and Maxillofacial Surgery, Faculty of Oral and Dental Medicine, Cairo University

  STUDY DIRECTOR

Central Study Contacts

Nehal I Shobair, PhD

CONTACT

+201063666985; nehal.shobair@miuegypt.edu.eg

Yassin S Alian, PhD

CONTACT

+201008161547; Yassinalian@dent.asu.edu.eg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, Department of Oral and Maxillofacial Surgery, Misr International University

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 25, 2025
• Study Start: March 12, 2025
• Primary Completion: April 15, 2025
• Study Completion: May 1, 2025
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)