NCT05401994已完成不适用
Screw Retained Arch Bar Versus Conventional Erich's Arch Bar in Maxillomandibular Fixation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- oral hygiene measuring with Oral Hygiene Index-Simplified (OHI-S)
研究概览
简要总结
A randomized prospective clinical study to compare screw Retained Arch Bar and Conventional Erich's Arch Bar in Maxillomandibular Fixation
详细描述
- Patients with non-pathological favorable or non-favorable fracture of mandible or maxilla that can be treated by MMF when acceptable occlusion can be obtained via bimanual reduction will be divided randomly into two equal groups: Group I: 10 patients will receive conventional Erich's arch bar. Group II: 10 patients will receive modified screw retained arch bar.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients age ranges from 18 to 50 years.
- •Patients with non-pathological favorable or non-favorable fracture of mandible or maxilla that can be treated by MMF when acceptable occlusion can be obtained via bimanual reduction.
- •Patients medically free from any systemic disease that absolutely contraindicate the surgical procedures.
排除标准
- •Edentulous ridge fracture. 2) Patients having primary and mixed dentition.
结局指标
主要结局
oral hygiene measuring with Oral Hygiene Index-Simplified (OHI-S)
时间窗: 4-6 weeks
the OHI-S values range from 0 to 6.OHI-S score is good between 0 and 1.2, medium between 1.3 and 3, and poor between 3.1 and 6.
duration of surgical procedure in minutes
时间窗: intraoperative
Duration between the starting of fixation and complete fixation of fracture
maxillomandibular fixation stability in nominal scale(stable-unstable)
时间窗: 4-6 weeks
stability after fixation
次要结局
- number of iatrogenic injuries(intraoperative)
- pain assessment using numeric rating scale (NRS)(immediately postoperative)
- number of needle and wire stick injuries(intraoperative)
研究者
研究点 (2)
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