3D Titanium Plates for Mandibular Parasymphyseal Fracture Fixation

The Use of 3d Titanium Plates With Two Different Profile Thickness for Open Reduction and Rigid Fixation of Mandibular Parasymphyseal Fracture:Randomised Clinical Trial

Mandibular fractures pose significant challenges in maxillofacial surgery due to their frequency, potential for functional impairment, and aesthetic concerns. Open reduction and internal fixation (ORIF) using titanium plates and screws have revolutionized the management of mandibular fractures.

The advent of 3D printing technology has ushered in a new era of patient-specific implants, offering improved adaptation to individual anatomy and potentially enhancing surgical outcomes.

Study Overview

• Status: Completed
• Conditions: Mandibular Parasymphyseal Fractures
• Intervention / Treatment: Device: 3D Titanium Plates

Detailed Description

The face is the window through which we perceive the world around us, and the world noted us. It serves a crucial role in human interaction and injuries to it result in devastating emotional sequelae. The human face constitutes the first contact point in several human interactions, thus injuries and/or mutilation of the facial structures may have a disastrous influence on the affected person.

The facial area is one of the most frequently injured parts of the body, and the mandible is one of the most commonly fractured maxillofacial bones. For the past decades, there has been a significant increase in maxillofacial traumas involving mandible. They are mainly caused by vehicular accidents, sport activities, penetrating injuries, physical assault, work-related accident, metabolic diseases or tumors.

The position, prominence, anatomic configuration, mobility and less bone support of the mandible make it one of the most frequent facial bones to be fractured. The mandibular fracture accounts for 36% to 54% of all fractures in the maxillofacial region. Mandible is the 10th most fractured bone in the whole body. They may occur alone or in combination with other facial bone fractures.

It plays a major role in mastication, speech, and deglutition. Its fractures result in severe loss of function and disfigurement. Fractures through the mandible at the level of the Symphysis and or parasymphysis are relatively common and account for approximately 20% of mandibular fractures. These fractures are often associated with a second fracture of the mandible, especially in the subcondylar region.

Fractures of the symphyseal region are often associated with the clinical findings of a widened intragonial distance with resultant malocclusion. Fractures of the anterior mandible lack two of the stabilizing factors provided to fractures of the posterior tooth-bearing mandible: the splinting effects of the masseter and internal pterygoid muscles, which form a natural sling, and the interlocking cusps and fossae of bicuspid and molar teeth.

Internal fixation in long bones has been adapted with particular modifications for the mandible. The disadvantage with these rigid plates was movement of the fracture fragment while tightening the screws resulting in malocclusion. Also, these plates could only be minimally adapted to the fracture fragments and produced more tension on the bone resulting in loosening of screws. They also require an extraoral approach and are highly technique sensitive.

The introduction of the 3-dimension (3D) system for the treatment of mandibular fractures has offered certain advantages over other plating systems. These plates function as internal fixator, achieving stability by 3D plates. A unique advantage of 3D system is that there is no need to adapt plate over the underlying bone, making plate adaptation easier.

Theoretical advantages proposed include close approximation, greater stability across the fracture site, less precision required in plate adaptation because of the internal/external fixator, less alteration in osseous or occlusal relationship upon screw tightening and, and less time required.

Although several materials can be used for manufacture of small plates, generally titanium is used because of its excellent biocompatibility, resistance to corrosion and pliability. Champy's miniplates require intra oral approach, less technique sensitive and produce consistently good results with regard to occlusion and also avoid the need for intermaxillary fixation

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza Governorate
    • Cairo, Giza Governorate, Egypt
      • Dentistery Hospital, Cairo Universiy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ranging between 20-60 years.
• Patients with mandibular parasymphyseal fractures requiring open reduction and fixation..
• Patients with good health (ASA -I and ASA- II) without any contraindication for surgery or anesthesia.

Exclusion Criteria:

• Patients with pre existing neurological or musculoskeletal disease.
• Patients with infected fractures.
• Patients with simultaneous condylar fracture.
• Patients with regional malignancy.
• Medically compromised patients.
• Patients with blood diseases or severe renal disorders.
• Patients refuse to share in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A (3d titanium plates of 2 mm): About 9 patients suffered from Mandibular Parasymphyseal Fracture treated by using 3d titanium plates of 2 mm thickness.	Device: 3D Titanium Plates; to compare 3d titanium plates with two different profile thickness for open reduction and rigid fixation of mandibular parasymphyseal fracture.; Other Names: Open Reduction and Rigid Internal Fixation
Active Comparator: Group B (3d titanium plates of 0.7 mm): About 9 patients suffered from Mandibular Parasymphyseal Fracture treated by using 3d titanium plates of 0.7 mm thickness.	Device: 3D Titanium Plates; to compare 3d titanium plates with two different profile thickness for open reduction and rigid fixation of mandibular parasymphyseal fracture.; Other Names: Open Reduction and Rigid Internal Fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment of Postoperative pain	Treatment of the pain resulted from using 3d titanium plates with two different profile thickness for open reduction and fixation of mandibular Parasymphyseal fracture by using a standardized pain scale.	48 Hours from the operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative Complications	Secondary outcomes will be evaluated to assess the clinical effectiveness and safety of using 3D titanium plates with different profile thicknesses in the fixation of mandibular body fractures (as infection, malocclusion, and hardwarerelated complications).	from1 week to 6 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Mohamed Atef, Professor, Oral and Maxillofacial Surgery, Faculty of Dentistry, Kasr Al-Aini

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2024
• Primary Completion (Actual): December 15, 2025
• Study Completion (Actual): February 15, 2026

Study Registration Dates

• First Submitted: June 11, 2026
• First Submitted That Met QC Criteria: June 11, 2026
• First Posted (Actual): June 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Surgical Procedures, Operative; Orthopedic Procedures; Fracture Fixation; Open Fracture Reduction
• Other Study ID Numbers: Mandibular Fracture

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