EFFICACY OF NOVEL UNI-PLATING SYSTEM FOR SYMPHYSIS FRACTURE BASED ON CHAMPY’S LINE OF OSTEOSYNTHESIS : AN IN VITRO AND IN VIVO STUDY
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Post-operative stability of the plating system.
研究概览
简要总结
This study aims to evaluate the efficacy of a novel uni-plating system for the fixation of symphysis fractures following Champy’s line of osteosynthesis principles. The research is designed as a non-comparative study conducted in two phases.
In Vitro Phase – Biomechanical testing of the novel uni-plating system on synthetic bone models to assess stability and load-bearing capacity.
In Vivo Phase – Clinical application of the novel plating system in patients with symphysis fractures to evaluate functional outcomes, stability, and postoperative complications over a defined follow-up period.
The study aims to establish the efficacy, feasibility, and potential advantages of this novel plating system in fracture management. Clinical parameters such as fracture healing, occlusal stability, infection rates, and patient-reported outcomes will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Fractures in the symphysis region of the mandible, which may be simple or compound or comminuted fractures Fractures suitable for treatment through an intra-oral approach and extra oral approach for pre-existing laceration.
- •Individuals approved for surgery by a physician according to ASA classification.
- •Patients willing to actively participate in clinical and radiological follow-up throughout the study period.
排除标准
- •Patients unwilling for receiving treatment.
- •Patients presenting with cysts and tumors.
结局指标
主要结局
Post-operative stability of the plating system.
时间窗: 24 hours, 7 days, 3 months and 6 months post-operative visits.
次要结局
- achievement of occlusal stability
研究者
Dr Chinta Chetana Hota
Sri Siddartha Dental College