Custom Titanium Plates vs. 3D Splints in LeFort I Osteotomy

April 23, 2025 updated by: Abdalkareem Mansour, Azhar University

A Randomized Comparative Study of Customized Titanium Plates Versus Three-Dimensional (3D)-Printed Splints for Maxillary Repositioning Accuracy in LeFort I Orthognathic Surgery

This randomized comparative study evaluates the accuracy and feasibility of two techniques for maxillary repositioning in Le Fort I osteotomy:

Customized titanium plates (splintless technique)

Three-dimensional (3D)-printed intermediate splints

Participants (n = 12) aged 18-30 years with dentofacial deformities will be equally divided into two groups:

Group I: Osteotomy guided by patient-specific surgical guides, fixed with pre-bent customized titanium plates.

Group II: Osteotomy guided by 3D-printed intermediate splints with conventional fixation.

Primary Outcome Accuracy of maxillary repositioning (measured as millimeter [mm] deviation from the virtual surgical plan), assessed via computed tomography (CT) superimposition using Mimics software at one week postoperatively.

Secondary Outcomes

Operative time

Fabrication accuracy of the customized titanium plate and 3D-printed splint

Postoperative complications (e.g., infection, plate failure)

Hypothesis Customized titanium plates will reduce maxillary positioning errors and operative time compared to 3D-printed splints.

Relevance This study may validate splintless techniques for improved precision in orthognathic surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background and Rationale Orthognathic surgery relies on precise maxillary repositioning to achieve both functional and aesthetic outcomes. Traditional techniques using three-dimensional (3D)-printed splints are limited by potential errors in splint seating, condylar positioning, and vertical dimension control. Emerging splintless approaches using customized titanium plates and cutting guides-designed through virtual surgical planning (VSP)-may improve accuracy by eliminating interocclusal splints, preventing condylar sagging, and reducing operative time. This study compares these two techniques in Le Fort I osteotomy, addressing the evidence gap for splintless feasibility, particularly in resource-limited settings.

Study Design Type: Prospective, randomized, single-blind, parallel-group comparative trial.

Setting: Al-Azhar University, Faculty of Dental Medicine, and Sayyed Galal University Hospital (Cairo, Egypt).

Aim of the Study To assess the accuracy and stability of customized titanium plates versus the 3D-printed splint technique in Le Fort I osteotomy for orthognathic surgery.

Population Twelve patients (aged 18-30 years) with dentofacial deformities classified as American Society of Anesthesiologists (ASA) Class I or II, who do not require a segmental Le Fort I osteotomy, are not pregnant or suspected of pregnancy, and have no prior orthognathic surgery or facial anomalies.

Participants were randomized 1:1 into:

Group I (Experimental): Patient-specific cutting guides + customized titanium plates (splintless technique).

Group II (Comparator): 3D-printed intermediate splints + conventional fixation with miniplates and screws.

Blinding: Outcome assessors analyzing computed tomography (CT) scans was blinded to group allocation.

Interventions Preoperative Planning All patients underwent CT imaging (1 mm slices) and dental cast scanning using intraoral scanners to create stereolithography (STL) files. The composite model was merged using Mimics 21.0 software for virtual surgical planning (VSP). Orthopantomography was used to evaluate dentition. Lateral cephalometry was performed for analytical planning.

Virtual Planning Process:

Occlusal registration

STL file production

Digital Imaging and Communications in Medicine (DICOM) file generation

Surgical simulation

Transfer method planning

Digital dental models were generated via high-resolution scanning and merged with the 3D skull model to replace the less accurate CT dental data, resulting in a highly accurate composite skull model using Mimics Medical 21.0 (Materialise NV, Leuven, Belgium).

Group I: The customized titanium plate system included a pair of cutting guides with preplanned screw holes and a pair of custom fixation plates. STL files were exported for fabrication using two 3D printers.

Group II: Teeth-borne 3D intermediate splints were designed and printed to guide surgical movement of osteotomized segments.

Surgical Procedures All patients were admitted to the hospital and underwent routine lab investigations and specialty evaluations (cardiac, thoracic, internal medicine). Surgery was performed under general anesthesia with sterile preparation.

Le Fort I Osteotomy:

A standard Le Fort I osteotomy was performed via a maxillary vestibular approach (incision from upper first molar to opposite first molar, 5 mm above the mucogingival junction).

The flap was elevated to fit the cutting guide. Osteotomies were performed on the lateral maxillary wall, lateral nasal wall, nasal septum, and pterygoid plates. The maxilla was disimpacted and repositioned:

Group I: Fixed using customized titanium plates.

Group II: Repositioned using a 3D-printed splint and fixed with conventional titanium miniplates.

Bilateral Sagittal Split Osteotomy (BSSO):

Performed through the mandibular vestibular approach.

The incision extended from the anterior border of the ramus to the lower first molar.

Osteotomy began at the medial ramus wall above the mandibular foramen, extended to the anterior border, and completed with a vertical cut to the mandible's lower border.

Mandibular segments were repositioned with intermediate splints in both groups. Surgery was only performed if indicated.

Group I (Splintless):

Maxillary cutting guides were fixed in position based on unique anatomical features of the maxillozygomatic buttress and anterior wall.

Cutting lines and screw holes were marked.

After removing the guides, osteotomies were completed, and the maxilla was repositioned and fixed with custom titanium plates and screws.

Group II (3D-Printed Splint):

Osteotomized jaw segments were aligned using the 3D-printed intermediate splint.

Intermaxillary fixation was applied, followed by rigid fixation with conventional miniplates and screws.

Postoperative Protocol CT scans were performed one week postoperatively to assess accuracy of cutting guides, customized titanium plates, and 3D-printed splints.

Follow-up: Clinical evaluations at 1 week, 1 month, 3 months, 6 months, and 12 months to assess occlusion and complications.

Outcomes Primary outcome: Maxillary repositioning accuracy (mm deviation from VSP) CT superimposition (Mimics 21.0)

Secondary outcomes:

Operative time (incision-to-fixation)

Fabrication accuracy of customized plate and 3Dprinted splint:

  • Outcome occlusion (Canine/Angle classification)
  • Complication rates (infection, plate failure, sensory deficits) Clinical records Statistical Analysis Sample Size: n = 6 per group (80% power, α = 0.05, effect size d = 1.94-2.18), based on Karanxha et al. (2020).

Tests:

Independent t-tests or Mann-Whitney U tests for intergroup comparisons. Paired t-tests for pre- vs. postoperative CT deviations. Software: SPSS v26 Significance threshold: p < 0.05

Ethical and Regulatory Considerations IRB Approval: Granted by Al-Azhar University (protocol attached).

Informed Consent: Written informed consent obtained from all participants (Arabic language).

Data Handling: All CT data and models anonymized and securely stored. Only aggregated results will be published.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Egypt
    • Bab Al Sheraya. ELObera
      • Cairo, Bab Al Sheraya. ELObera, Egypt, 11558
        • Sayyed Galal hospital

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Patients with dentofacial deformities requiring Le Fort I orthognathic surgery. Patients aged between 18 and 30 years. Medically healthy patients classified as American Society of Anesthesiologists (ASA) Class I or II.

Exclusion Criteria:

Patients requiring a segmental Le Fort I osteotomy. Patients with suspected or confirmed pregnancy. Patients with a previous history of orthognathic surgery. Patients with cleft palate or other craniofacial anomalies.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: customized titanium plates group
"Patients whose surgery was guided by a personalized orthognathic surgical guide, with the maxillary segments fixed using a pair of customized titanium plates."
Procedure: Patient-Specific Titanium Plates
Custom 3D-printed titanium fixation plates and cutting guides
Active Comparator: 3D printed splint group
"Patients whose surgery was guided by an intermediate splint, designed based on the final virtual model and fabricated using computer-aided manufacturing (CAM) technology.
Procedure: 3D-Printed Intermediate Splint
CAD/CAM-fabricated occlusal splint for maxillary positioning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of custom-made plate vs 3D printed splint
Time Frame: postoperative one week
Accuracy of Outcomes of Custom-Made Plate and 3D-Printed Splint The accuracy of outcomes for both the custom-made titanium plates and the 3D-printed splints will be assessed by comparing the planned virtual outcomes to the actual postoperative results. Postoperative computed tomography (CT) scans will be superimposed onto the planned models using the Mimics Medical 21.0 software (Materialise NV, Leuven, Belgium). The discrepancies between the planned and actual outcomes will be measured in millimeters to evaluate surgical accuracy.
postoperative one week

Collaborators and Investigators

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

Sponsor

Azhar University

Investigators

  • Study Chair: wael A El-Mohandes, professor, Azhar University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Actual)

January 10, 2023

Primary Completion (Actual)

January 1, 2025

Study Completion (Actual)

April 1, 2025

Study Registration Dates

First Submitted

April 11, 2025

First Submitted That Met QC Criteria

April 11, 2025

First Posted (Actual)

April 18, 2025

Study Record Updates

Last Update Posted (Actual)

April 25, 2025

Last Update Submitted That Met QC Criteria

April 23, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 887/1849

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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