Clinical, Radiographic and Histological Evaluation of Z-shaped Bone Plates in Management of Mandibular Fractures
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Postoperative pain assessed using the Visual Analog Scale (VAS)
研究概览
简要总结
he goal of this clinical trial is to evaluate Z shaped bone plate in mandibular fracture treatment regarding post operative healing, function restoration and esthetic.
aims to answer are: In mandibular trauma population, what is the difference between internal fixation using conventional miniplates compared to z shaped bone plates regarding post operative healing, function restoration and esthetic?
Participants will be divided equally and randomly in 2 groups as follows:
Group A: eight patients treated with Z shaped bone plate. (Study group) Group B: eight patients restored with conventional two miniplates.(control group)
详细描述
Introduction
Various miniplate systems have been developed in recent years including three-dimensional miniplate, microplates and bioresorbable plate, and their advantages and disadvantages have been compared and studied. To overcome the shortcomings of 3D plating system such as difficulty in adaptation and fixation in fractures involving the mental nerve, a Z plate has been designed. Aim: to evaluate Z shaped bone plates in mandibular fracture management clinically, radiographically, and histologically. Methodology: sixteen patients with mandibular fracture grouped to two groups group A managed by Z plates, group B managed by two miniplates. Patients will follow up clinically postoperative. Radiographic evaluation will be performed immediately postoperative, 1 month and 4 months Experimental study will be on dogs and histological evaluation.
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
- 19 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are suffering from recent, uninfected, and minimally displaced or unfavorable fractures at the symphysial or parasymphysis region of the mandible.
- •Adult patients with no gender predilection that agreed to present for follow-up visits for minimum postoperative period of immediate, month, 3 months,6 months.
- •A fracture that demands open reduction and internal fixation
- •Medically fit patients for general anesthesia
排除标准
- •Comminuted, infected mandibular fracture.
- •Pediatric patients below 14 years of age
- •geriatric patients with completely edentulous mouth.
结局指标
主要结局
Postoperative pain assessed using the Visual Analog Scale (VAS)
时间窗: day 1 , day 3, and 1week postoperative
postoperative pain assessed using the Visual Analog Scale (VAS). Range: 0 (no pain) - 10 (worst imaginable pain). Higher scores indicate worse pain
Radiographic evaluation (Bone density ratio at fracture line ) measured using orthopantomograms (OPGs) by ImageJ software.
时间窗: within 1week postoperative, 1month, 4month
Radiographic evaluation using orthopantomograms (OPGs) is performed immediately postoperatively, at 1 month and 4 months. To assess bone density along the fracture line, a densitometric analysis was conducted using the ImageJ system. Digital images are analyzed using ImageJ software. The mean gray value of a region of interest (ROI) drawn along the entire length of the fracture line was calculated. This gray value represents the relative bone density within the fracture site. Range: 0.0 - 1.0 (unitless ratio). Higher values indicate greater bone density and better healing
次要结局
- Clinical fracture stability evaluated by manual mobility test and tenderness on palpation.(1 week postoperative,1month, 3 months, 6 months)
研究者
Eman Mohamed Eldemardash Ali
Assistant Lecturer oral and maxillofacial surgery department, Faculty of Dentistry
Suez Canal University