Evaluation of Accuracy of Patient-Specific Plate for Reduction and Fixation of Mandibular Angle Fracture

Tanta University

Status: Completed

Conditions: Mandibular Angle Fracture

Treatments: Device: Patient-Specific Titanium Plate

Study type: Interventional

Funder types: Other

Identifiers

NCT07231042

TANTAOMFS-MAF-160

Details and patient eligibility

About

This study evaluates the accuracy and clinical effectiveness of patient-specific titanium plates designed using CAD/CAM technology for the reduction and fixation of mandibular angle fractures. The customized plates are manufactured to match each patient's anatomical morphology, aiming to improve surgical precision, minimize operative time, and enhance postoperative stability. The study assesses clinical outcomes including pain, edema, occlusion, sensory recovery, maximal mouth opening, and radiographic bone healing across multiple follow-up periods. The goal is to determine whether patient-specific plates offer superior clinical and radiographic results compared with conventional fixation methods.

Full description

This clinical study investigates the use of computer-aided design and computer-aided manufacturing (CAD/CAM) technology to fabricate patient-specific titanium plates for the reduction and fixation of mandibular angle fractures. The customized plates are created based on each patient's CT-derived anatomical morphology, allowing the surgical team to perform virtual planning, simulate fracture reduction, and generate an accurately fitted plate prior to surgery.

The primary objective of the study is to assess the accuracy of anatomical reduction achieved using patient-specific plates and to evaluate short- and medium-term clinical outcomes. All patients are treated using an intraoral surgical approach, with fracture reduction performed according to the preoperative virtual plan. The patient-specific titanium plate is then positioned and fixed without the need for intraoperative plate bending.

Clinical outcomes evaluated in this study include postoperative pain, facial edema, maximal mouth opening, sensory recovery of the inferior alveolar nerve, dental occlusion, and wound healing. Radiographic assessment evaluates bone healing, alignment, intergonial distance, and the accuracy of fracture reduction across multiple follow-up intervals. These evaluations aim to determine the stability and precision of the patient-specific fixation method.

The study follows patients through standardized follow-up periods, including immediate postoperative assessment, 1-week, 1-month, 3-month, and 6-month evaluations. Data are collected prospectively using unified clinical forms and radiological imaging protocols. All procedures adhere to ethical guidelines, and informed consent is obtained from all participants prior to enrollment.

The rationale behind using patient-specific plates is the potential to improve biomechanical stability, reduce operative time, eliminate intraoperative plate bending, and achieve more predictable postoperative outcomes. This study aims to provide evidence on whether CAD/CAM-based customized plates offer measurable advantages over conventional fixation systems in the treatment of mandibular angle fractures.

Enrollment: 10 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient with displaced mandibular angle fracture indicated for open reducation and internal fixation.
2. Age of patient > 18 years old .

Exclusion criteria

1- Medically compromised patients with impaired healing ability.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Patient-Specific Titanium Plate Fixation

Experimental group

Description:

All participants will undergo open reduction and internal fixation of displaced mandibular angle fractures using a patient-specific titanium plate fabricated by CAD/CAM technology. The customized plate provides accurate anatomical adaptation, enhanced stability, and reduced operative time.

Treatment:

Device: Patient-Specific Titanium Plate