The Use of 3d Titanium Plates With Two Different Profile Thickness for Open Reduction and Rigid Fixation of Mandibular Parasymphyseal Fracture:Randomised Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Treatment of Postoperative pain
Study Overview
Brief Summary
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: 3D Titanium Plates (Device)
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.
Intervention: 3D Titanium Plates (Device)
Outcomes
Primary Outcomes
Treatment of Postoperative pain
Time Frame: 48 Hours from the operation
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.
Secondary Outcomes
- Incidence of postoperative Complications(from1 week to 6 months)
Investigators
Hala Omar Elmoursey
Researcher of Oral and maxillofacial Surgery
Cairo University