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

Virtually Designed Custom-Made Titanium Plate Versus Three-Dimensional Lambda Plate for Management of Mandibular Subcondylar Fractures: (A Randomized Controlled Trial)

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.

Study Overview

• Status: Completed
• Conditions: Mandibular Sub-condylar Fracture
• Intervention / Treatment: Device: Custom-Made Plate Group; Device: Three-Dimensional Lambda Plate

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Gharbia Governorate
    • Tanta, Gharbia Governorate, Egypt, 31527
      • Faculty of Dentistry, Tanta University.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.
Active Comparator: 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.	Device: Three-Dimensional Lambda Plate; Standard ready-made three-dimensional titanium lambda plate used for open reduction and internal fixation of mandibular subcondylar fractures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time	The total operative time required to perform open reduction and internal fixation of mandibular subcondylar fractures, measured from incision to completion of fixation. The outcome will be compared between the custom-made titanium plate group and the 3D lambda plate group.	Intraoperative (recorded during the surgical procedure)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scor (VAS)	Visual Analog Scale score to assess postoperative pain intensity over time.	Immediate postoperative, 1 week, 2 weeks, 1 month, 3 months, 6 months.
Occlusal Function (Uglesic Score)	Evaluation of occlusal stability and masticatory function using the Uglesic et al. (1993) occlusion questionnaire.	1 week, 1 month, 3 months, 6 months.
Mouth Opening (Maximum Inter-Incisal Distance, mm)	Measurement of maximal mouth opening to evaluate functional recovery.	Preoperative, 1 week, 2 weeks, 1 month, 3 months, 6 months.
Radiographic Bone Healing (Computed Tomography Evaluation)	Computed Tomography based evaluation of bone union, accuracy of reduction and consolidation at the fracture site.	1 month, 3 months, 6 months.

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: Mohammed A Almasoud, Faculty of Dentistry, Tanta University, Egypt; Principal Investigator: Mohamed M Khedr, Faculty of Dentistry, Tanta University, Egypt; Principal Investigator: Ahmed A Mosleh, Faculty of Dentistry, Tanta University, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2024
• Primary Completion (Actual): July 30, 2025
• Study Completion (Actual): October 29, 2025

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: November 13, 2025
• First Posted (Actual): November 17, 2025

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: CAD/CAM; Randomized Controlled trial; Mandibular sub-condylar fractures; Fractures of mandible; condylar fractures of mandible; Patient specific plate; Virtual Surgical planning
• Other Study ID Numbers: TU-OMFS-2025-SUBCONDYLAR-CT

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