跳至主要内容
临床试验/CTRI/2025/04/084497
CTRI/2025/04/084497招募中不适用

Evaluation of treatment outcomes in double mandibular fracture management with mixed versus non-rigid fixation – A randomized controlled trial.

DrPavithraM1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2025年4月19日最近更新:

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

发起方
DrPavithraM
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

DrPavithraM

AIIMS, Mangalagiri, Andhra Pradesh - 522503

研究点 (1)

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