Mandibular Fractures, Parasymphysis Fractures, Symphysis Fractures
Conditions
Keywords
Anterior mandibular fracture, Parasymphysis fracture, Symphysis fracture, Pin Buckle bone plate, Conventional miniplate, Internal fixation, Maxillofacial trauma, Bone plate, Computed tomography, Randomized clinical trial, Open reduction and internal fixation
Brief summary
This randomized clinical study aims to evaluate the clinical and radiographic outcomes of a novel Pin Buckle bone plate compared with conventional two-miniplate fixation for the management of anterior mandibular (symphysis and parasymphysis) fractures. Twenty adult patients requiring open reduction and internal fixation will be randomly allocated into two equal groups. The study group will receive fixation using the Pin Buckle bone plate, while the control group will be treated using conventional titanium miniplates. Clinical outcomes including pain, edema, wound healing, and postoperative complications will be evaluated during the postoperative follow-up period. Radiographic assessment using computed tomography (CT) will be performed immediately after surgery and at 6 months to evaluate bone density. The study seeks to determine whether the Pin Buckle bone plate provides improved postoperative healing and functional outcomes compared with conventional miniplate fixation.
Interventions
DEVICEPin Buckle Bone Plate
A titanium Pin Buckle bone plate used for internal fixation of anterior mandibular fractures following open reduction.
Conventional titanium miniplates used for internal fixation of anterior mandibular fractures following open reduction according to Champy's principles.
Sponsors
Suez Canal University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants were randomly assigned in a 1:1 ratio to receive fracture fixation using either the Pin Buckle bone plate (study group) or conventional two-miniplate fixation (control group). Outcomes were compared between the two parallel groups during the postoperative follow-up period.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Adult patients aged 18 to 55 years old. * Adult patients of either gender. * Patients who are free from any systemic disease (ASA I). * Patients suffering from recent, simple and single symphyseal or parasymphyseal mandibular fractures. * Unfavorable fractures requiring open reduction and internal fixation. * Patients willing to attend all postoperative follow-up visits.
Exclusion criteria
* Pregnant or lactating women. * Patients with associated maxillofacial injuries that may interfere with study outcomes. * Patients with comminuted mandibular fractures. * Patients with infected fractures. * Patients with pathological fractures. * Previously failed fixation of symphyseal or parasymphyseal fractures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Bone Density | Preoperative, immediately postoperative and after 6 months | Bone density at the fracture site was measured in Hounsfield Units (HU) on multislice CT using standardized regions of interest to evaluate osseous healing. |
| Wound Healing | Day 1, Day 7, and Day 14 | Wound healing was assessed clinically using the Southampton Wound Assessment Scale, which evaluates postoperative wound healing based on the presence and severity of normal healing, erythema, bruising, discharge, wound dehiscence, and infection. Higher grades indicate poorer wound healing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain | Day 1, Day 7, and Day 14 | Pain intensity was assessed using a 10-cm Visual Analogue Scale (VAS), where 0 indicated no pain and 10 indicated the worst pain imaginable. |
| Postoperative Edema | Day 1, Day 7, and Day 14 | Facial edema was evaluated clinically by visual inspection and palpation and categorized as none, low-grade, intermediate-grade, or high-grade according to the severity of facial swelling. |
Countries
Egypt
Contacts
STUDY_CHAIRMohamed Said Hamed, Professor
Professor of Oral and Maxillofacial Surgery - Faculty of Dentistry - Suez Canal University
STUDY_DIRECTORAhmed Abdelmohsen Younis, Associate Professor
Associate Professor of Oral and Maxillofacial Surgery - Faculty of Dentistry - Suez Canal University
PRINCIPAL_INVESTIGATORMohamed Abdelnaby, B.S.D
Resident Zagazig University Hospital
Outcome results
None listed