Clinical Trial

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

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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.
Trial Details
NCT Number NCT07365657
Lead Sponsor Centre Hospitalier Universitaire de Nice
Conditions Malocclusion
Enrollment 2 participants
Start Date 2026-01-20
Primary Completion 2026-01-23 (estimated)
Study Completion 2026-01-23 (estimated)
Updated on ClinicalTrials.gov 2026-01-26