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临床试验/CTRI/2024/12/078744
CTRI/2024/12/078744尚未招募不适用

Efficacy OF 3D Miniplates for Internal Fixation of Anterior Mandibular Fractures

Parijat Sinha1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年3月11日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
10
试验地点
1
主要终点
Reduced operative time

研究概览

简要总结

The hypothesis suggests that the use of 3D miniplates for symphysis and para-symphysis fracture fixation provides advantages in terms of reduced operative time, and minimal implant material usage compared to traditional fixation methods.

The primary purpose of the study is to evaluate the

Decrease in the incidence of malocclusion and hardware failure.

Simultaneous stabilization of the tension and compression zones.

Reduced operating time, due to less time required for adaptation of 3D plate

Reduced post-operative edema due to less soft tissue dissection.

Decrease in the incidence of paresthesia

Moreover, 3D plates provide more stability in 3 dimensions against torsion forces, vertical displacement, bending, and shearing forces

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Cases with fractures in the mandibular symphysis and parasymphysis region.

排除标准

  • Comminuted symphysis and parasymphysis fractures Patients with pre-existing infection at fracture site Completely edentulous patients Immuno-Compromised patients Patients with other systemic conditions contraindicated for surgery.

结局指标

主要结局

Reduced operative time

时间窗: At baseline

Minimal implant material

时间窗: At baseline

次要结局

  • Reduced edema(Stability in 3 dimensions)

研究者

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

Parijat Sinha

Sree Balaji Dental College and Hospital

研究点 (1)

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