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

NCT ID: NCT07231042

Last Updated: 2025-11-17

Basic Information

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

Brief Summary

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.

Detailed 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.

Conditions

Mandibular Angle Fracture

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patient-Specific Titanium Plate Fixation

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.

Group Type: EXPERIMENTAL

Patient-Specific Titanium Plate

Intervention Type: DEVICE

A customized titanium fixation plate designed using computer-aided design and manufacturing (CAD/CAM) technology based on preoperative CT data. The plate is fabricated to precisely match the patient's mandibular anatomy and used for open reduction and internal fixation of mandibular angle fractures.

Interventions

Patient-Specific Titanium Plate

A customized titanium fixation plate designed using computer-aided design and manufacturing (CAD/CAM) technology based on preoperative CT data. The plate is fabricated to precisely match the patient's mandibular anatomy and used for open reduction and internal fixation of mandibular angle fractures.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Abdulaziz Mohsen A Alanazi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abdulaziz M Alanazi

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, Tanta University, Egypt

Ibrahim M Nowair

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, Tanta University, Egypt

Mona S sheta

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, Tanta University, Egypt

Locations

Faculty of Dentistry, Tanta University

Tanta, Gharbia Governorate, Egypt

Countries

Egypt

Other Identifiers

TANTAOMFS-MAF-160

Identifier Type: -

Identifier Source: org_study_id