Evaluation of the Use of Modified 3d Rectangular Grid Plate for Fixation of Anterior and Body Mandibular Fractures (Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- change in maximum mouth opening
研究概览
简要总结
Background: Fractures of anterior mandible (symphysis and parasymphysis) make up about 9% to 57%, of mandibular fractures, and body fractures make up about 21%; posing challenges for stabilization due to anatomical constraints. Traditional 3D plates have limitations in this area, leading to the development of Modified 3D Rectangular Grid plates. Studies have shown that these plates offer superior stabilization over larger configurations while maintaining a low profile like miniplates. Additionally, design modifications ensure mental nerve preservation, balancing effective fixation with neurovascular safety.
Aim of this study: To evaluate the use of Modified 3D Rectangular Grid plates in comparison with conventional mini plates for fixation of mandibular fracture in the anterior and body regions, clinically regarding pain, interfragmentary mobility, maximal inter-incisal opening, wound healing, and sensory nerve evaluation, and radiographically regrading fracture reduction.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from recent fractures at the symphysis, parasymphysis and body regions
- •Adult patients with no gender predilection who agreed to present for follow-up visits
- •A fracture that demands open reduction and internal fixation.
- •The patient is medically fit for general anesthesia
排除标准
- •ASA classification IV, V, VI
- •Existence of infection at the fracture line
- •Pathological fracture
- •An old fracture
- •Completely edentulous patient
- •Patients with a comminuted fracture
研究组 & 干预措施
3D plates
干预措施: Modified 3D Rectangular Grid plate (Other)
Conventional plates
干预措施: Two conventional miniplates (Other)
结局指标
主要结局
change in maximum mouth opening
时间窗: up to 12 weeks
Using a millimetre ruler to measure maximal inter-incisal mouth opening; considered to be adequate if \>30 mm and inadequate if \<30 mm
change in pain scores
时间窗: up to 12 weeks
Will be assessed through a 10-point Visual Analogue Scale (VAS). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe
change in Neurosensory function
时间窗: up to 12 weeks
patient was asked about prescence of sensation alteration
change in maximum mouth opening
时间窗: up to 6 weeks
Using a millimetre ruler to measure maximal inter-incisal mouth opening; considered to be adequate if \>30 mm and inadequate if \<30 mm
change in pain scores
时间窗: up to 6 weeks
Will be assessed through a 10-point Visual Analogue Scale (VAS). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe
次要结局
- change in Inter-fragmentary Mobility(up to 12 weeks)
- change in Wound Evaluation(up to12 weeks)
- adequacy of fracture line reduction(12 weeks)
- change in Inter-fragmentary Mobility(up to 6 weeks)
- change in Wound Evaluation(up to 6 weeks)
- adequacy of fracture line reduction(6 weeks)