Comparative Trial of Custom-Made Titanium Plates Versus 3D Lambda Plates for Mandibular Subcondylar Fractures

NCT ID: NCT07231055

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-28
• Study Completion Date: 2025-10-29

Brief Summary

This randomized clinical trial compares virtually designed custom-made titanium plates with conventional three-dimensional (3D) lambda plates for the fixation of mandibular subcondylar fractures. A total of 24 fracture sites will be treated using a retromandibular trans-masseteric approach and evaluated through virtual surgical planning, radiographic analysis, and functional outcomes. The study aims to determine whether customized plates provide superior anatomical accuracy, stability, and recovery compared with standard 3D plates.

Detailed Description

Mandibular subcondylar fractures can affect occlusion, mandibular function, and facial symmetry, and remain a topic of ongoing clinical debate regarding optimal fixation methods. Conventional management often relies on standardized three-dimensional (3D) plates, such as the lambda configuration, which provides reliable fixation but may not precisely conform to the individual patient's anatomy.

Advances in virtual surgical planning (VSP) and computer-aided design now allow for the fabrication of patient-specific titanium plates that follow the exact contours of each patient's mandibular anatomy. These customized implants may improve reduction accuracy, minimize inter-fragmentary gaps, enhance postoperative stability, and reduce intraoperative manipulation.

In this study, 24 subcondylar fracture sites will be randomly assigned to either a patient-specific custom-made plate group or a conventional 3D lambda plate group. All procedures will be performed using the retromandibular trans-masseteric approach. Preoperative planning will include CT-based segmentation, virtual fracture reduction, and 3D model generation. Postoperative follow-up will be conducted at multiple intervals to assess radiographic bone healing, condylar and gonial width symmetry, inter-fragmentary gap, mandibular function, pain scores, occlusion, edema, and soft tissue healing.

The study seeks to evaluate whether the use of a customized fixation system results in measurable improvements in surgical precision and functional recovery compared with standard 3D plating techniques. Findings from this clinical trial may support evidence-based decision-making in the selection of fixation systems for subcondylar fractures and clarify the potential clinical benefits of patient-specific implant technology.

Conditions

Mandibular Sub-condylar Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Custom-Made plate Group

Patient-specific titanium plate fabricated using virtual surgical planning, CT-based segmentation, and 3D design for fixation of mandibular subcondylar fractures.

Group Type: EXPERIMENTAL

Custom-Made Plate Group

Intervention Type: DEVICE

Virtually designed Patient-specific titanium plate fabricated using virtual surgical planning, CT-based segmentation, and 3D design for fixation of mandibular subcondylar fractures.

Three-Dimensional (3D) Lambda plate Group

Standard ready-made three-dimensional titanium lambda plate used for open reduction and internal fixation of mandibular subcondylar fractures.

Group Type: ACTIVE_COMPARATOR

Three-Dimensional Lambda Plate

Intervention Type: DEVICE

Standard ready-made three-dimensional titanium lambda plate used for open reduction and internal fixation of mandibular subcondylar fractures.

Interventions

Custom-Made Plate Group

Virtually designed Patient-specific titanium plate fabricated using virtual surgical planning, CT-based segmentation, and 3D design for fixation of mandibular subcondylar fractures.

Intervention Type: DEVICE

Three-Dimensional Lambda Plate

Standard ready-made three-dimensional titanium lambda plate used for open reduction and internal fixation of mandibular subcondylar fractures.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adult Patients with mandibular subcondylar fracture indicated for open reduction and internal fixation.

Exclusion Criteria

• Patients with systemic diseases that affect tissue healing.
• Mandibular condylar head or neck fractures. (Condylar neck is the where the caudal portion of the joint capsule attaches. It is the thin constricted area immediately below the condylar head.)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Ahmed Thamer Al Masoud

Sponsor-Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohammed A Almasoud

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, Tanta University, Egypt

Mohamed M Khedr

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, Tanta University, Egypt

Ahmed A Mosleh

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, Tanta University, Egypt

Locations

Faculty of Dentistry, Tanta University.

Tanta, Gharbia Governorate, Egypt

Countries

Egypt

Other Identifiers

TU-OMFS-2025-SUBCONDYLAR-CT

Identifier Type: -

Identifier Source: org_study_id