Evaluation of treatment outcomes in double mandibular fracture management with mixed versus non-rigid fixation – A randomized controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- To compare the treatment outcomes of mixed fixation (Group-1) versus non-rigid fixation (Group-2) in patients with double mandibular fractures by evaluating preoperative and
研究概览
简要总结
Mandibular fractures are among the most common fractures of the facial skeleton, and the complex
anatomy of the mandible makes it susceptible to fractures at multiple sites, which can be on the same side or opposite. Over the past 40 years, mandibular
fractures have been treated using a technique called open reduction and internal fixation, which for a single fracture, can involve either a single miniplate
for non-rigid fixation or stronger reconstruction plates for rigid fixation. However, treating double mandibular fractures is challenging because the segment
in between two fractures lack support on either side resulting in rotational movement. Previous studies recommend different approaches for the management
of double mandibular fractures. Some suggest that a non-rigid fixation scheme can be used for both fractures, few suggest rigid fixation at least at one
fracture site and others recommend rigid fixation for both fractures. Despite the common occurrence of double mandibular fractures (22% to 52%), there is
limited knowledge regarding standardized, evidence-based, best fixation strategies. To address this gap, the present randomized controlled trial (RCT) will
compare the outcomes of non-rigid fixation alone and a combination of rigid and non-rigid internal fixation. This study aims to provide clearer guidelines
for the management of double mandibular fractures, ensuring better treatment outcomes and functional rehabilitation.
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
- 16.00 Year(s) 至 90.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients with double mandibular fractures (ipsilateral or contralateral) 2) Patients with permanent dentition and a sufficient number of teeth to evaluate occlusion.
- •Patients or their guardians who are willing to provide written informed consent for the surgical procedure and follow-up.
排除标准
- •Comminuted mandibular fractures.
- •Fractures associated with active infection, non-union, malunion 3) Patients with ASA – IV / Immunocompromised patients 4) Patients with bone and metabolic disorders.
结局指标
主要结局
To compare the treatment outcomes of mixed fixation (Group-1) versus non-rigid fixation (Group-2) in patients with double mandibular fractures by evaluating preoperative and
时间窗: Bite force, occlusal alignment, hardware integrity, wound healing status - a day before surgery, after surgery day-1, after 6 weeks and 3 months
postoperative bite force, occlusal alignment, hardware integrity, and wound healing status.
时间窗: Bite force, occlusal alignment, hardware integrity, wound healing status - a day before surgery, after surgery day-1, after 6 weeks and 3 months
次要结局
- Secondary Objectives:(• To assess the radiographic alignment of fractures following fixation)
研究者
DrPavithraM
AIIMS, Mangalagiri, Andhra Pradesh - 522503
