Evaluating 3D Soft Tissue Simulation for Jaw Surgery
Segmented 3D Facial Conformation Meshes and Regional Esthetic Subunits: Advancing Soft Tissue Prediction Planning for Orthognathic Surgery: A Retrospective Study
This study tests if using 3D imaging can help plan jaw surgery better for people with certain facial deformities.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 13 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Cairo, Abbassia and 1 other locations) |
| Trial ID | NCT06893614 on ClinicalTrials.gov |
What this trial studies
This observational study conducts a retrospective analysis of existing Cone Beam Computed Tomography (CBCT) scans from patients who underwent bimaxillary orthognathic surgery for Class III dentofacial deformities. It aims to assess the accuracy of 3D soft tissue predictions using advanced imaging techniques and software. By integrating segmented 3D facial meshes and analyzing various facial regions, the study seeks to enhance the precision of surgical planning and outcomes. The methodology includes voxel-based registration and color-coded error maps to visualize prediction accuracy.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with Class III dentofacial deformities who have undergone bimaxillary orthognathic surgery and have preoperative and at least 6 months postoperative CBCT scans available.
Not a fit: Patients with craniofacial anomalies, previous maxillofacial surgeries, or significant facial asymmetry may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the accuracy of soft tissue predictions in orthognathic surgery, leading to better surgical outcomes for patients.
How similar studies have performed: Other studies utilizing 3D imaging and soft tissue prediction models have shown promising results, indicating that this approach is both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Where this trial is running
Cairo, Abbassia and 1 other locations
- Ain Shams University — Cairo, Abbassia, Egypt (Recruiting)
- Ain Shams University — Abbassia, Cairo Governorate, Egypt (Recruiting)
Study contacts
- Principal investigator: Nehal I Shobair, Lecturer — Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Misr International University, Cairo, Egypt
- Study coordinator: Nehal I Shobair, PhD
- Email: nehal.shobair@miuegypt.edu.eg
- Phone: +201063666985
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.