Clinical and Radiographic Evaluation of Pin Buckle Bone Plates for Management of Anterior Mandibular Fractures: A Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Radiographic Bone Density
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Radiographic Bone Density
时间窗: 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
时间窗: 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.
次要结局
- Postoperative Pain(Day 1, Day 7, and Day 14)
- Postoperative Edema(Day 1, Day 7, and Day 14)
研究者
Mohamed abdelnaby
Principal Investigator
Suez Canal University