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

NCT07231055 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-11-17

No results posted yet for this study

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.

Conditions

  • Mandibular Sub-condylar Fracture

Interventions

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.

DEVICE

Three-Dimensional Lambda Plate

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

Sponsors & Collaborators

  • Tanta University

    lead OTHER

Principal Investigators

  • Mohammed A Almasoud · Faculty of Dentistry, Tanta University, Egypt

  • Mohamed M Khedr · Faculty of Dentistry, Tanta University, Egypt

  • Ahmed A Mosleh · Faculty of Dentistry, Tanta University, Egypt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-28
Primary Completion
2025-07-30
Completion
2025-10-29

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07231055 on ClinicalTrials.gov