Comparative evaluation of 3d Locking Plates, 3d Non-locking plates, Locking and Non- locking Conventional Miniplates in the treatment of Mandibular fractures.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Occlusion : Present or absent
研究概览
简要总结
THIS IS A PROSPECTIVE STUDY COMPARING THE EFFICACY OF CONVENTIONAL LOCKING AND NONLOCKING MINIPLATES, 3D LOCKING AND NON LOCKING MINIPLATES. SUBJECTS WILL BE SELECTED BASED ON INCLUSION AND EXCLUSION CRITERIA VISITING THE OUT PATIENT DEPARTMENT OF OMFS FOR THE TREATMENT OF MANDIBULAR FRACTURES. SUBJECTS WILL BE DIVIDED RANDOMLY INTO FOUR GROUPS.
SUBJECTS WILL BE TREATED ACCORDING TO RESPECTIVE STUDY GROUP AND RESULTS WILL BE EVALUATED AT AN INTERVAL OF 1 DAY, 3RD DAY, 15TH DAY, 30TH DAY FOR PRIMARY AND SECONDARY OUTCOMES.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •All clinically and radiographically confirmed mandibular fractures.
- •Healthy subject ASA-1&2.
排除标准
- •Medically compromised subject ASA-3&
- •Edentulous subject.
- •Subject with comminuted fractures.
- •Subjects not able to come for follow up and those who do not give consent to be part of the study.
结局指标
主要结局
Occlusion : Present or absent
时间窗: At baseline | 3rd day | 15th day | 1 month
Fracture stability : By checking interfragmentary mobility manually.
时间窗: At baseline | 3rd day | 15th day | 1 month
Pain : Based on VAS
时间窗: At baseline | 3rd day | 15th day | 1 month
次要结局
- Paresthesia(Infection)
研究者
Dr Smile Singla
Government Dental College And Research Institute, Bangalore