NCT07365657

Finite Element Modelling of Le Fort I Osteotomy Fixation : PSI vs Miniplates

Subject-specific Finite Element Modelling of Le Fort I Osteotomy Fixation : Patient-specific Implants vs Miniplates

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2 (estimated)
• Sponsor: Centre Hospitalier Universitaire de Nice · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aimed to evaluate the biomechanical performance of patient-specific versus conventional fixation for Le Fort I osteotomy using subject-specific finite element models derived from real surgical plans. Two distinct clinical scenarios-a minor advancement without impaction and a moderate advancement with posterior impaction-were analyzed to determine how surgical movements influence implant stress, bone stress, and maxillary micromotion. By combining surgical planning with validated computational modeling, this work provides clinically relevant insight to optimize PSI design and guide fixation strategy selection in orthognathic surgery.

Conditions

• Malocclusion

Interventions

Type	Name	Description
OTHER	In silico orthognathic surgery with customized implants digital only on 3D scanners	2 patients : one with type II maloclusion, one with type III maloclusion who previously undergone orthognathic surgery

Timeline

• Start date: 2026-01-20
• Primary completion: 2026-01-23
• Completion: 2026-01-23
• First posted: 2026-01-26
• Last updated: 2026-01-26

Locations

1 site across 1 country: France