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

ConditionMalocclusion
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Nice

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient operated on By Pr SAVOLDELLI.

Patient undergoing patient-specific orthognathic surgery.

Access to numerical (digital) planning.

Disqualifiers

Previous maxillo-facial trauma.

Facial cleft.

Trial population

2 patients : one with type II maloclusion, one with type III maloclusion who previously undergone orthognathic surgery

Trial design

Design model

Other

Time perspective

Retrospective

Treatments tested in this trial

  • In silico orthognathic surgery with customized implants digital only on 3D scanners

    Other intervention

    2 patients : one with type II maloclusion, one with type III maloclusion who previously undergone orthognathic surgery

Treatment groups

2 Participants
are divided into 2 treatment groups
Group A: Type II maloclusion1 intervention
Group B: Type III maloclusion1 intervention

Trial outcomes

Primary outcomes

1

Plate stress levels

assessed by FORGE software

Time frame
At the inclusion

Secondary outcomes

1

Stress on bone

Mechanical stress in mecanics is measured in Pa (Pascal)

Time frame
At the inclusion
2

Maxillary displacement

Displacement levels in mecanics is measured in millimeters or micrometers.

Time frame
At the inclusion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Universitaire de Nice

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: