A comparative study to evaluate efficacy of double-y shaped miniplate and 3-d miniplate versus conventional miniplate in interforaminal mandibular fractures – A randomized controlled trial.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1. To determine the best available plating option among the most commonly used systems of plating in the interforaminal region.
研究概览
简要总结
Despite the promising Bio mechanical advantages of three-dimensional painting system and double Y plating system, their remains paucity in the clinical data comparing these novel designs with conventional mini plates in the management of Mandibular fractures, while several studies have explored the bio mechanical properties and in vitro performance of these systems. Robust clinical trials that comprehensively assess outcomes such as fracture, stability, occlusal restoration, post-operative pain, infection rates, and recovery of bite force are limited. Such comparative analysis are essential as the optimal fixation technique not only influences the immediate surgical outcome but also affects long-term functional recovery and patient satisfaction along with providing a reference to the surgeon to determine the best plating system based on the type of fracture. The presence study is designed to address this critical gap and literature by assessing the best fixation technique Among double -y And three dimensional mini plates versus conventional methods for the most common mandibular fractures.
Study design: in vivo study.
Study population: study will be performed on patients reporting to the institution for seeking treatment for interforaminal mandibular fractures. The patients will be prospectively randomised into three groups as follows.
Group 1-ORIF with double Y shaped mini plate
Group 2-ORIF with three dimensional mini plate
Group 3-ORIF with conventional double mini plates.
Evaluation parameters:
Pre-operatively,
Clinical parameters-
Segmental mobility, occlusion, teeth in the line of fracture
Radiological parameters-
Displacement of fracture
Intra operatively,
Clinical parameters-
Plate handling time, ease of plate, adaptation and positioning of plates, adequacy of fracture reduction.
Post operatively,
Clinical parameters-
Fracture stability, occlusion discrepancy, neuro sensory deficit, severity of pain, condition of teeth in the line of fracture.
Radiological parameters-
Adequacy of reduction, lingual splaying.
Other outcomes determined-
Wound dehiscence, fracture of plate, screws loosening, Infections, non union or malunion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient in the age group 18 to 65 years.
- •Patient reporting with interforaminal mandibular fractures indicated for open reduction and internal fixation.
排除标准
- •Patient with severely comminuted fracture.
- •Patient with infected mandibular interforaminal fracture.
- •Patient with systemic conditions affecting the bones and teeth.
- •Patient with psychiatric illness.
结局指标
主要结局
1. To determine the best available plating option among the most commonly used systems of plating in the interforaminal region.
时间窗: Post op day 1, post op day 7 and 1 month post operatively.
次要结局
- To determine which plating system takes the least operative time.(Intraoperatively)
- To determine the plating system that best controls lingual splaying postoperatively.(Post op day 1, post op day 7 and 1 month post operatively)
- To determine the plating system that provides best post-operative results.(Post op day 1, post op day 7 and 1 month post operatively.)
- To establish a reference for the surgeon to determine the plating system based on the case.(Post op day 1, post op day 7 and 1 month post operatively.)
研究者
Dr Suraj Sathyendra
Rajarajeswari Dental College and Hospital