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

NCT07841067 | Recruiting

• 1 other identifier: FUE.REC(66)/5-2026
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Orthognathic Surgery; Le Fort I Osteotomy; Dentofacial Deformities; Malocclusion, Angle Class II; Malocclusion, Angle Class III; Milled Titanium Plates; 3D Printed Titanium Plates

Outcome Measures

Primary Outcomes (1)

• 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).

  Immediate postoperative period (within the first week postoperatively)

Secondary Outcomes (2)

• Operative Time

  Intraoperatively (from initial surgical incision to final suture closure)

• Postoperative Stability

  Immediate postoperative period (within 1 week postoperatively)

Study Arms (2)

3D-Printed Patient-Specific Titanium Plates

EXPERIMENTAL

Participants in this group undergo Le Fort I osteotomy with maxillary repositioning and fixation using 3D-printed (additive manufactured) patient-specific grade 5 titanium alloy plates. Plate placement is guided by pre-drilled reference holes established via CAD/CAM cutting guides and secured with 2.0-mm screws.

Device: 3D-Printed Patient-Specific Titanium Plates

Milled Patient-Specific Titanium Plates

ACTIVE COMPARATOR

Participants in this group undergo Le Fort I osteotomy with maxillary repositioning and fixation using milled (subtractive manufactured) patient-specific grade 5 titanium alloy plates. Plate placement is guided by pre-drilled reference holes established via CAD/CAM cutting guides and secured with 2.0-mm screws.

Device: Milled Patient-Specific Titanium Plates

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

3D-Printed Patient-Specific Titanium Plates

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

Milled Patient-Specific Titanium Plates

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Future University in Egypt: lead

Study Sites (1)

Oral and Maxillofacial Surgery Department, Faculty of Oral and Dental Medicine, Future University in Egypt

Cairo, New Cairo, Fifth Settlement, 11835, Egypt

RECRUITING

Related Publications (18)

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• Bai S, Shang H, Liu Y, Zhao J, Zhao Y. Computer-aided design and computer-aided manufacturing locating guides accompanied with prebent titanium plates in orthognathic surgery. J Oral Maxillofac Surg. 2012 Oct;70(10):2419-26. doi: 10.1016/j.joms.2011.12.017. Epub 2012 Apr 18. No abstract available.

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MeSH Terms

Conditions

Malocclusion, Angle Class II; Malocclusion, Angle Class III; Dentofacial Deformities

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc Candidate in Oral and Maxillofacial Surgery Department, Future University in Egypt

Model Details: This study uses a parallel assignment model. Eligible participants will be randomized into two groups: one group will undergo Le Fort I osteotomy with fixation using 3D-printed patient-specific titanium plates, and the other group will undergo the same procedure with milled patient-specific titanium plates. Each participant will receive only one intervention, and outcomes will be compared between the two groups.

Study Record Dates

• First Submitted: September 19, 2026
• First Posted: September 25, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09

Locations

EG (1)