A Randomized Comparative Study of Customized Titanium Plates Versus Three-Dimensional (3D)-Printed Splints for Maxillary Repositioning Accuracy in LeFort I Orthognathic Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Accuracy of custom-made plate vs 3D printed splint
Study Overview
Brief Summary
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
"Both the participants and outcome assessors were blinded to the method of virtual surgical planning (VSP) implementation-whether using customized titanium plates or 3D-printed splints-to minimize bias."
Eligibility Criteria
- Ages
- 18 Years to 30 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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."
Intervention: Patient-Specific Titanium Plates (Procedure)
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.
Intervention: 3D-Printed Intermediate Splint (Procedure)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Abdalkareem Mansour
Assistant Lecturer
Azhar University