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

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

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.

Study Overview

• Status: Completed
• Conditions: Mandibular Angle Fracture
• Intervention / Treatment: Device: Patient-Specific Titanium Plate

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• 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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of Fracture Reduction	Accuracy of anatomical reduction will be evaluated by comparing postoperative CBCT scans with preoperative virtual surgical plans using superimposition analysis to measure the deviation between planned and achieved fragment positions.	Immediately and 1 week postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain Intensity	Pain intensity will be recorded using a Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (worst pain).	1 day, 1 week, and 1 month postoperatively
Postoperative Facial Edema	Facial swelling will be measured using the Souza JA facial edema scale based on standardized anthropometric landmarks.	1 week and 2 weeks postoperatively
Occlusal Relationship and Stability	Occlusal stability will be evaluated clinically using the Uglešić occlusion score to assess the degree of alignment and functional contact between opposing teeth	1 week, 1 month, and 3 months postoperatively
Recovery of Inferior Alveolar Nerve Function	Sensory recovery of the lower lip and chin will be assessed using light touch and two-point discrimination tests	1 week, 1 month, and 3 months postoperatively
Radiographic Bone Healing	Bone union and callus formation will be assessed radiographically on CBCT images to confirm complete healing and stability at the fracture site.	3 and 6 months postoperatively

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: Ibrahim M Nowair, Faculty of Dentistry, Tanta University, Egypt; Principal Investigator: Abdulaziz M Alanazi, Faculty of Dentistry, Tanta University, Egypt; Principal Investigator: Mona S sheta, 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; Titanium Plate; Maxillofacial Trauma; Virtual Surgical Planning; Patient-Specific Plate; Mandibular Fracture; Angle Fracture
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Fractures, Bone; Craniocerebral Trauma; Trauma, Nervous System; Facial Injuries; Jaw Fractures; Maxillofacial Injuries; Skull Fractures; Mandibular Fractures
• Other Study ID Numbers: TANTAOMFS-MAF-160

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