Modified 3d Rectangular Grid Plate for Fixation of Anterior and Body Mandibular Fractures
Evaluation of the Use of Modified 3d Rectangular Grid Plate for Fixation of Anterior and Body Mandibular Fractures (Randomized Controlled Clinical Trial)
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.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Azarita
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Alexandria、Azarita、埃及、00203
- Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：3D plates
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The system consists of a lower 1.5-mm rectangular plate and an upper linear plate that interlock through circular recesses and elevations. Each component is 0.75 mm thick at the junction, giving a total thickness of 1.5 mm. After screw fixation, it provides 3D stability similar to standard 3D plates while minimizing risk to the mental nerve. |
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有源比较器：Conventional plates
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conventional mini plates for fixation of mandibular fracture in the anterior and body regions |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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change in maximum mouth opening
大体时间：up to 12 weeks
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Using a millimetre ruler to measure maximal inter-incisal mouth opening; considered to be adequate if >30 mm and inadequate if <30 mm |
up to 12 weeks
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change in pain scores
大体时间：up to 12 weeks
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Will be assessed through a 10-point Visual Analogue Scale (VAS). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe |
up to 12 weeks
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change in Neurosensory function
大体时间：up to 12 weeks
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patient was asked about prescence of sensation alteration |
up to 12 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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change in Inter-fragmentary Mobility
大体时间：up to 12 weeks
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The mobility will be assessed by bi-manual palpation across the fracture site. |
up to 12 weeks
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change in Wound Evaluation
大体时间：up to12 weeks
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The sutured wounds will be examined for signs and symptoms of infection uisng modified Landry's index |
up to12 weeks
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adequacy of fracture line reduction
大体时间：12 weeks
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Whenever alignment of the inferior border of the mandible will be maintained across the fracture line, it will be considered an excellent reduction. If a discrepancy of 1-3 mm will be noted, it will be considered a good reduction. If a discrepancy of 3-5 mm will be noted, it will be labeled as a fair reduction. If the discrepancy will be > 5 mm, it will be considered a poor reduction. |
12 weeks
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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