Clinical trial Recruiting at 2 sites Observational Ages 18 to 50

Evaluating 3D Soft Tissue Simulation for Jaw Surgery

Official title: Segmented 3D Facial Conformation Meshes and Regional Esthetic Subunits: Advancing Soft Tissue Prediction Planning for Orthognathic Surgery: A Retrospective Study

Run by Ain Shams University · NCT06893614 · Data updated 2026-11-12

This study tests if using 3D imaging can help plan jaw surgery better for people with certain facial deformities.

Quick facts

Study typeObservational
Ages18 Years to 50 Years
SexAll
Enrollment13 (estimated)
SponsorAin Shams University
Academic / other
Drugs / interventionsradiation
Locations2 sites (Cairo, Abbassia and 1 other locations)
StatusRecruiting
StartedMarch 12, 2025
Main results expectedApril 15, 2025
Study endsMay 1, 2025
Registry record updatedMarch 25, 2025
Trial IDNCT06893614 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably not a fit

Patients with craniofacial anomalies, previous maxillofacial surgeries, or significant facial asymmetry may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Other studies utilizing 3D imaging and soft tissue prediction models have shown promising results, indicating that this approach is both relevant and potentially impactful.

Who can join: the full rules

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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.