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

January 16, 2026 updated by: Centre Hospitalier Universitaire de Nice

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Alpes Maritimes
      • Nice, Alpes Maritimes, France, 06000
        • CHU Nice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Patient operated on By Pr SAVOLDELLI.
  • Patient undergoing patient-specific orthognathic surgery.
  • Access to numerical (digital) planning.

Exclusion Criteria:

  • Previous maxillo-facial trauma.
  • Facial cleft.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Type II maloclusion
2 patients : one with type II maloclusion, one with type III maloclusion who previously undergone orthognathic surgery
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
Type III maloclusion
2 patients : one with type II maloclusion, one with type III maloclusion who previously undergone orthognathic surgery
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plate stress levels
Time Frame: At the inclusion
assessed by FORGE software
At the inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stress on bone
Time Frame: At the inclusion
Mechanical stress in mecanics is measured in Pa (Pascal)
At the inclusion
Maxillary displacement
Time Frame: At the inclusion
Displacement levels in mecanics is measured in millimeters or micrometers.
At the inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 20, 2026

Primary Completion (Estimated)

January 23, 2026

Study Completion (Estimated)

January 23, 2026

Study Registration Dates

First Submitted

January 16, 2026

First Submitted That Met QC Criteria

January 16, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26IUFC01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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