Clinical and Radiographic Evaluation of Pin Buckle Bone Plates for Management of Anterior Mandibular Fractures: A Randomized Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Suez Canal University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Radiographic Bone Density
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
Radiographic Bone Density
Time Frame: 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
Time Frame: 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 Outcomes
- Postoperative Pain(Day 1, Day 7, and Day 14)
- Postoperative Edema(Day 1, Day 7, and Day 14)
Investigators
Mohamed abdelnaby
Principal Investigator
Suez Canal University