Comparative efficacy of miniplate fixation with centric versus eccentric screw placement in open reduction and internal fixation of mandibular fractures: A randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1. Assessment of stability of fixation as evaluated by stability of occlusion at 7th, 14th, 21st, and 28th post-op day.
研究概览
简要总结
This randomized controlled trial aims to evaluate and compare the efficacy of miniplate fixation using centric versus eccentric screw placement in the treatment of mandibular symphysis and parasymphysis fractures. The study focuses on assessing fixation strength, occlusal stability, bone healing through bite force measurement, and postoperative complications. Thirty patients will be randomly assigned to two groups. The surgical technique, outcomes, and follow-up evaluations are systematically planned. The hypothesis is that eccentric screw placement may enhance fracture stability by generating interfragmentary compression. The study aims to improve surgical outcomes and provide evidence-based recommendations for mandibular fracture management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients 18–55 years with isolated mandibular symphysis or parasymphysis fractures.
- •Presence of occlusal disturbance due to the fracture.
- •Patients willing to participate and provide written informed consent.
排除标准
- •Pediatric patients, pregnant women, or lactating mothers.
- •Medically compromised individuals who are at high surgical risk.
- •Patients unable to attend postoperative follow-ups for at least 3 months.
结局指标
主要结局
1. Assessment of stability of fixation as evaluated by stability of occlusion at 7th, 14th, 21st, and 28th post-op day.
时间窗: 1. Assessment of stability of fixation as evaluated by stability of occlusion at 7th, 14th, 21st, and 28th post-op day. | 2. Assessment of better bone healing as evaluated by recording bite force using a calibrated digital bite force meter at 7th, 14th, 21st, and 28th post-operative day. | Secondary
2. Assessment of better bone healing as evaluated by recording bite force using a calibrated digital bite force meter at 7th, 14th, 21st, and 28th post-operative day.
时间窗: 1. Assessment of stability of fixation as evaluated by stability of occlusion at 7th, 14th, 21st, and 28th post-op day. | 2. Assessment of better bone healing as evaluated by recording bite force using a calibrated digital bite force meter at 7th, 14th, 21st, and 28th post-operative day. | Secondary
Secondary
时间窗: 1. Assessment of stability of fixation as evaluated by stability of occlusion at 7th, 14th, 21st, and 28th post-op day. | 2. Assessment of better bone healing as evaluated by recording bite force using a calibrated digital bite force meter at 7th, 14th, 21st, and 28th post-operative day. | Secondary
次要结局
- - To compare the rate of complications with either technique of treatment.(at 7th, 14th, 21st, and 28th post-operative day)
研究者
ANKIT KUMAR
kothiwal dental college