3D Titanium Plates for Mandibular Body Fracture Fixation

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

Mandibular body fracture 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.

Recent advancements in technology have led to the development of patient-specific 3D titanium implants, offering the potential for improved anatomical fit and stability. Moreover, the concept of low-profile implants has gained traction, aiming to minimize soft tissue irritation and enhance patient comfort postoperatively.

Study Overview

• Status: Completed
• Conditions: Mandibular Body Fracture
• Intervention / Treatment: Device: 3D Titanium Plates

Detailed Description

Facial trauma is common in road traffic accidents (RTA). Due to modernization, increased number of vehicles and failure to follow traffic rules are among various causes of facial trauma. Mandible is one of the frequently fractured bones in RTA. It has been observed that the most common sites of mandibular fracture are angle, body, and ramus.

The incidence of mandibular fracture ranges between 40% and 65% of all facial fractures and so are twice as common as fractures of the midfacial bones. Fractures of the angle of mandible can present with long term disabling sequelae and make up 23%-42% of all fractures in the mandible.

Other than traumatic injuries of the face, there are several factors leading to mandibular body fracture as direct impact or blunt force trauma, indirect trauma to the chin or side of the face, facial fractures, osteoporosis, tumors or cysts in the jawbone, some dental procedures, elderly population, and occupational hazards.

Long term sequel of untreated or poorly treated fractures includes various impairments such as functional, aesthetic, neurological and psychological. The main goal in the treatment of bone fracture is to predictably restore its preinjury anatomical form, with associated aesthetics and function. Techniques for treatment of mandibular fracture have evolved significantly in past decades. These techniques have ranged from closed reduction with maxillomandibular fixation, open reduction with wire osteosynthesis, to open reduction with either rigid internal fixation or adaptive miniplate fixation.

They are best managed by placing one single plate in neutral zone that is sub-apically along with arch bar as tension band. However, in case of severely displaced fractures, inadequate dentition or presence of associated fractures, there are changes in biomechanical vector of forces, which demands for rigid fixation like two plates or load-bearing fixation.

Monocortical plates stabilize the fracture two-dimensionally which can be inadequate fixation in the above-mentioned situations especially in load-bearing area that has led to development of 3D plates. 3D plates are quadrangular in geometry providing stability three-dimensionally due to its design and compact form which counteract against the torsional forces especially in intermental foramen region.

Open reduction and internal fixation (ORIF) using titanium plates and screws have become the standard of care for stabilizing displaced mandibular body fracture, facilitating proper alignment, and promoting optimal healing. However, the optimal design and thickness of these implants remain subjects of debate among maxillofacial surgeons.

• 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: Yes

Description

Inclusion criteria:

• Age ranging between 20-60 years.
• Patients with mandibular body 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 fracture treated by using 3d titanium plates of 2 mm thickness.	Device: 3D Titanium Plates; to compare the 3D titanium plates with two different profile thickness for open reduction and fixation of mandibular body 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 fracture treated by using 3d titanium plates of 0.7 mm thickness.	Device: 3D Titanium Plates; to compare the 3D titanium plates with two different profile thickness for open reduction and fixation of mandibular body 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 body 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 hardware-related complications).	from1 week to 6 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Mohamed Atef, Professor, of 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 Fixation

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
• product manufactured in and exported from the U.S.: Yes