3D Interlocking Miniplates Versus Conventional Miniplates in Fixation of Mandibular Fractures in the Mental Foramen Region: A Split-mouth Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 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 3D Interlocking miniplates with conventional miniplates in management of mandibular parasymphyseal fractures both clinically and radiographically.
详细描述
A total of 12 patients with recent bilateral parasymphyseal mandibular fractures were treated with 3D Interlocking miniplates on one side and with conventional two miniplates in the other side. Clinical evaluations were carried at multiple intervals up to 6 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
Fracture sides 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 3D-interlocking miniplate in one side, and Group B with conventional double miniplates configration in the other side.
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 bilateral mandibular fracture located in the mental foramina region.
- •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
patient with bilateral fracture in the mental nerve region managed with 3D-interlocking miniplate
patient with bilateral fracture in the mental nerve region. one side will be randomly allocated to be managed with 3D-interlocking miniplate
干预措施: 3d-interlocking miniplate (Device)
patient with bilateral fracture in the mental nerve region managed with conventional miniplates
patient with bilateral fracture in the mental nerve region. one side will be randomly allocated to be managed with conventional miniplates
干预措施: Conventional miniplates (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: 12 weeks
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 Intra-fragmentary mobility(6 weeks)