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

NCT07231042 | Completed

• 1 other identifier: TANTAOMFS-MAF-160
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Mandibular Angle Fracture

Keywords

CAD/CAM; Patient-Specific Plate; Mandibular Fracture; Angle Fracture; Titanium Plate; Virtual Surgical Planning; Maxillofacial Trauma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Postoperative Pain Intensity

  1 day, 1 week, and 1 month postoperatively

• Postoperative Facial Edema

  1 week and 2 weeks postoperatively

• Occlusal Relationship and Stability

  1 week, 1 month, and 3 months postoperatively

• Recovery of Inferior Alveolar Nerve Function

  1 week, 1 month, and 3 months postoperatively

• Radiographic Bone Healing

  3 and 6 months postoperatively

Study Arms (1)

Patient-Specific Titanium Plate Fixation

EXPERIMENTAL

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

Interventions

Patient-Specific Titanium Plate 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.

Patient-Specific Titanium Plate Fixation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Medically compromised patients with impaired healing ability.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Dentistry, Tanta University

Tanta, Gharbia Governorate, 31527, Egypt

Location

MeSH Terms

Conditions

Mandibular Fractures

Condition Hierarchy (Ancestors)

Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries

Study Officials

• Abdulaziz M Alanazi

  Faculty of Dentistry, Tanta University, Egypt

  PRINCIPAL INVESTIGATOR

• Ibrahim M Nowair

  Faculty of Dentistry, Tanta University, Egypt

  PRINCIPAL INVESTIGATOR

• Mona S sheta

  Faculty of Dentistry, Tanta University, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A single-arm clinical study evaluating the accuracy, stability, and clinical outcomes of patient-specific titanium plates fabricated using CAD/CAM technology for fixation of mandibular angle fractures.

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: December 28, 2024
• Primary Completion: July 30, 2025
• Study Completion: October 29, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)