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Comparing 3D-Printed and Milled Titanium Plates in Jaw Surgery (Le Fort I): Accuracy and Operative Time

Sponsor: Future University in Egypt • ClinicalTrials.gov ID: NCT07841067

Registry updated: 2026-09-25

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Description

The purpose of this study is to find out if 3D printed patient-specific titanium plates improve surgical accuracy and decrease operative time compared to milled patient-specific titanium plates in patients having Le Fort I osteotomy for jaw correction. The main questions it aims to answer are: * Do 3D-printed patient specific titanium plates improve surgical accuracy (as measured by ability to transfer the computer plan to the patient's jaw)? * Do 3D-printed patient specific titanium plates decrease operative time when compared to milled patient specific titanium plates? This study will compare two groups of patients. One group will receive 3D printed plates (study group) and the other will receive milled plates (control group) to see if the different methods of making the plates changes the surgical accuracy or operative time. All participants in the study will: * Have Le Fort I osteotomy surgery using patient specific titanium plates (either 3D printed or milled). * Have CT scans before and after surgery to evaluate accuracy. Have their operative time recorded. * Have a post-surgical follow-up to evaluate healing, stability and orthodontic treatment.

Interventions

3D-Printed Patient-Specific Titanium Plates (Device)
Following a Le Fort I osteotomy performed with a reciprocating saw, the maxilla is repositioned and rigidly fixated using the 3D-printed patient-specific plates. Plate alignment is guided by 16 pre-drilled reference holes (8 per side) established using a customized cutting guide, and plates are secured using 2.0-mm screws
Milled Patient-Specific Titanium Plates (Device)
Following a Le Fort I osteotomy performed with a reciprocating saw, the maxilla is repositioned and rigidly fixated using the milled patient-specific plates. Plate alignment is guided by the same 16 pre-drilled reference holes (8 per side) established via a customized cutting guide, and plates are secured using 2.0-mm screws

Eligibility criteria

Inclusion Criteria: * Skeletally mature patients (typically ≥ 18 years old) with fused growth plates. * Non-syndromic skeletal Class II or Class III malocclusion requiring a Le Fort I osteotomy (with or without mandibular involvement). * Patients with no signs or symptoms of active temporomandibular disorders (TMD). * Patients with good oral hygiene and no active periodontal disease that could affect tooth-borne guides. * Highly motivated patients. Exclusion Criteria: * Patients who refused to be included in the research and patients unable to comply with follow up Protocol. * Patients with systemic diseases may hinder the normal healing process or render the patient not fit for general anesthesia. * Craniofacial anomalies or syndromes (cleft lip/palate, syndromic deformities). * Previous orthognathic surgery or revision cases. * Patients with intra-bony lesions or infections that may retard the osteotomy healing. * History of maxillofacial trauma altering anatomy.

Conditions

Malocclusion, Angle Class II Malocclusion, Angle Class III Dentofacial Deformities Osteotomy, Le Fort I

Locations

Oral and Maxillofacial Surgery Department, Faculty of Oral and Dental Medicine, Future University in Egypt — Cairo, New Cairo, Fifth Settlement, Egypt

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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