Reliability of a 2.3mm Mandibular Reconstruction Bone Plate in Mandibular Bone Preservation
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Rate of inflammation
研究概览
简要总结
The purpose of this study is to evaluate the reliability of using mandibular osteosynthesis a 2.3mm reconstruction bone plate in the maintenance of the space, contour, and mandibular bone preservation during marginal mandibular resection.
详细描述
This prospective study included 16 patients (n=16) suffering from presence of mandibular central benign lesions indicated for marginal mandibular resection.
Patient history included personal data (name, age, sex, and occupation), date of lesion discovery, mode of growth (rapid or slow), and symptoms (e.g. pain and/or ipsilateral paresthesia of the lower lip).
Clinical examination included the site and extent of mandibular bony expansion and covering soft tissues (normal, ulcerated from indentation of opposing teeth, or scarred due to previous incisional biopsy).
Radiographical examination involved orthopantomography (OPG) and axial and coronal computed tomography (CT) scans to assess the lesion extensions.
All patients are operated under general anesthesia which was induced by intravenous access. Intubation is routinely performed in nasoendotracheal fashion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients suffering from presence of mandibular central benign lesions indicated for marginal mandibular resection
排除标准
- •systemic disease affect primary wound healing malignancy
研究组 & 干预措施
Surgery/Device
Mandibular marginal resection and reconstruction using a mandibular osteosynthesis a 2.3mm reconstruction bone plate
干预措施: Mandibular marginal resection and reconstruction (Procedure)
Surgery/Device
Mandibular marginal resection and reconstruction using a mandibular osteosynthesis a 2.3mm reconstruction bone plate
干预措施: mandibular osteosynthesis a 2.3mm reconstruction bone plate (Device)
结局指标
主要结局
Rate of inflammation
时间窗: 1 month
The wounds were inspected accurately post-operatively for detecting the proper healing using inflammation score scale, 0 no inflammation,1-3 mild inflammation, 4-7,moderate inflammation, 8-10 sever inflammation
Rate of Infection
时间窗: 6 months
using Infection score scale , mild infection which responds to antibiotics, only without the need for incision and drainage, moderate infection which needs for incision and drainage and severe infection which needs for incision and drainage in addition to hardware removal.
Degree of pain
时间窗: 1 month
The degree of pain is determined during the follow up periods according the scale of Kerkmanov and Nordenram , Mild: require one tablet of analgesics three times/ day, Moderate: require two tablets of analgesics three times/ day, Severe: require injective analgesics.
次要结局
- Axial and coronal computed tomography(6 month)
研究者
Mohamed Kamal Eid Allam
Associate professor
Tanta University