InterFlex Plate Versus Conventional Miniplates in the Management of Anterior Mandibular Fractures. a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Radiographic evaluation for the assessment of mean bone density at the fracture line
研究概览
简要总结
the study aims to compare InterFlex plate with conventional miniplates in management of symphyseal mandibular fracture clinically regarding pain, wound healing and postoperative occlusion, and radiographically regrading bone density.
详细描述
A total of 18 patients with recent symphyseal mandibular fractures were allocated into two groups. Group A, comprising 9 patients, underwent treatment with the InterFlex plate, while Group B, also consisting of 9 patients, was treated with conventional two miniplates. Clinical evaluations were carried at multiple intervals up to 12 weeks postoperatively, with radiographic assessments performed immediately after surgery and at 12 weeks to measure mean bone density at the fracture line.
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
- Single (Investigator)
盲法说明
Patients were allocated in a 1:1 ratio using an on-site computer software system with concealed allocation through sequentially numbered, opaque, sealed envelopes (SNOSE). Group A was treated with InterFlex plates, and Group B with conventional miniplates
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with recent anterior mandibular fracture located between the mental foramina.
- •adults without gender predilection who agreed to follow-up,
- •fractures requiring open reduction and internal fixation, and
- •those medically fit for general anesthesia were included
排除标准
- •medically compromised patients,
- •fractures with infection,
- •pathological or old fractures,
- •completely edentulous patients,
- •comminuted fractures
研究组 & 干预措施
Patients with anterior mandibular fracture managed with conventional miniplates
Patients with anterior mandibular fracture managed with conventional miniplates
干预措施: conventional miniplates (Device)
Patients with anterior mandibular fracture managed with InterFlex plates
Patients with anterior mandibular fracture managed with InterFlex plates
干预措施: InterFlex plates (Device)
结局指标
主要结局
Radiographic evaluation for the assessment of mean bone density at the fracture line
时间窗: 3 months
Mean bone density at the fracture line was assessed using Cone-Beam Computed Tomography (CBCT) scan in Hounsfield Units (HU)
次要结局
- Clinical evaluation for pain(six weeks)