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

NCT06933628 | Completed

• 1 other identifier: 887/1849
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Dentofacial Deformities

Keywords

dentofacial deformities; customized titanium plates; PSI; virtual surgical planning; 3D printed splints

Outcome Measures

Primary Outcomes (1)

• Accuracy of custom-made plate vs 3D printed splint

  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

Study Arms (2)

customized titanium plates group

EXPERIMENTAL

"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

3D printed splint group

ACTIVE COMPARATOR

"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

Interventions

Patient-Specific Titanium Plates PROCEDURE

Custom 3D-printed titanium fixation plates and cutting guides

customized titanium plates group

3D-Printed Intermediate Splint PROCEDURE

CAD/CAM-fabricated occlusal splint for maxillary positioning

3D printed splint group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Sayyed Galal hospital

Cairo, Bab Al Sheraya. ELObera, 11558, Egypt

Location

Related Publications (1)

• Heufelder M, Wilde F, Pietzka S, Mascha F, Winter K, Schramm A, Rana M. Clinical accuracy of waferless maxillary positioning using customized surgical guides and patient specific osteosynthesis in bimaxillary orthognathic surgery. J Craniomaxillofac Surg. 2017 Sep;45(9):1578-1585. doi: 10.1016/j.jcms.2017.06.027. Epub 2017 Jul 8.

  PMID: 28793965 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Dentofacial Deformities

Condition Hierarchy (Ancestors)

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

Study Officials

• wael A El-Mohandes, professor

  Al-Azhar University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: "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."
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Model Details: Group I (Experimental Group): Patients whose surgery was guided by personalized orthognathic surgical guides. The maxillary segments were fixed using customized titanium plates designed through virtual surgical planning (VSP). Group II (Control 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. Fixation was completed with conventional titanium miniplates and screws.

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 18, 2025
• Study Start: January 10, 2023
• Primary Completion: January 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)