CTRI/2024/04/065648尚未招募Phase 3 4
Comparative assessment of efficiency and patient tolerance of hybrid arch bar, Erich’s arch bar and MMF screw placement in treatment of jaw fractures
Dr. D Y Patil dental college and hospital1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2024年4月22日最近更新:
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Gingival inflammation
研究概览
简要总结
A prospective randomized controlled clinical trial to be conducted on 45 patients with maxillofacial fractures requiring maxillomandibular fixation were split into 3 groups of 15 each. Patients in group A will be treated with Erich arch bar, patients in group B with MMF screws and patients in group C with hybrid arch bar. Factors to be assessed are gingival inflammation on day of removal and 7 days post removal of MMF appliance using modified gingival index, time taken for placement and removal in minutes and patient discomfort using visual analog scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients with maxillofacial fractures requiring maxillomandibular fixation.
排除标准
- •Patients with comminuted fractures of factial bones.
- •parhological fractures, edentulous ridges.
- •Patients with metabolic disorders, bleeding disorders, history of radiotherapy or chemotherapy.
结局指标
主要结局
Gingival inflammation
时间窗: 4 weeks post operative and 5 weeks post operative
次要结局
- Time taken for application of MMF appliance(Day 0)
- Time taken for removal of MMF appliance(4 weeks Post op)
- Patient discomfort(4 weeks post op)
研究者
CSSherwin Samuel
Dr. D Y Patil dental college and hospital
研究点 (1)
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