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.
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.
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.
Parallel
3D-Printed Patient-Specific Titanium Plates
DeviceFollowing 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
DeviceFollowing 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
Accuracy of Surgical Transfer
The primary outcome measures the precision with which the virtual surgical plan (P0/T0) is transferred to the actual surgical outcome (P1/T1). * Image Registration: The virtual surgical plan is superimposed onto the postoperative Computed Tomography (CT) scan using point-based matching Iterative Closest Point (ICP) registration, followed by manual surface-based best-fit registration targeting the stable skull base in Mimics 19.0 software. * Linear Measurement: Discrepancies between the planned and actual positions are measured from hard tissue reference points specifically the upper central incisor (U1) and upper first molars (16, 26): Vertical Deviation: Distance measured relative to the Frankfort Horizontal Plane (FHP). Anteroposterior Deviation: Distance measured relative to the Coronal Plane (CP). Mediolateral Deviation: Distance measured relative to the Mid-Facial Plane (MFP).
Operative Time
Operative time is defined as the total intraoperative duration required for all surgical procedures, including the positioning and fixation of the patient-specific titanium plate on the maxilla during Le Fort I osteotomy. The time is measured and recorded in minutes for each participant using a digital stopwatch, starting when the surgeon performs the first surgical incision and ending when the surgeon completes final closure suturing
Postoperative Stability
Evaluates the extent to which skeletal structures maintain their corrected position relative to the virtual surgical plan following Le Fort I osteotomy. Postoperative CT scans obtained within 1 week are imported into Mimics software and superimposed onto the virtual plan using stable skull base reference points. Linear deviations are evaluated at key hard tissue landmarks (central incisor U1, first molars 16 and 26) across three spatial dimensions
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