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临床试验/NCT04719325
NCT04719325已完成不适用

Comparative Study of Herbert Screw vs Lag Screw Fixation in Anterior Mandibular Fracture Treatment (a Clinical and Radiographic Study)

Hams Hamed Abdelrahman1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2019年10月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
12
试验地点
1
主要终点
change in pain scores

研究概览

简要总结

14 patients having recent anterior mandibular fracture divided into two groups. Group A has 6 patients and treated using Herbert bone screw, and group B has 6 patients and treated using lag screw.

Clinical follow-up was conducted after 24-hours, one, four, six, and twelve weeks. In addition, a radiographic investigation was performed after twelve weeks to estimate the mean bone density across the fracture line.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients suffering from recent, uninfected anterior mandibular fracture.
  • •Adult patients from 20-60 years old with no gender predilection agreed to present for follow-up visits for a minimum postoperative period of 3 months.
  • •Fracture that demands open reduction and internal fixation.

排除标准

  • •Medically compromised patients contradicting operations.
  • •Existence of infection at the fracture line.
  • •Pathological fracture.
  • •An old fracture.
  • •Completely edentulous patient

研究组 & 干预措施

Herbert screw

Experimental

干预措施: Herbert screw (Other)

Lag screw

Active Comparator

干预措施: Lag screw (Other)

结局指标

主要结局

change in pain scores

时间窗: 24 hours, 1 week , 4 Weeks and 6 weeks

assessed through a 10-point Visual Analogue Scale (VAS). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe)

Change in bone density

时间窗: baseline and 3 months

By using digital orthopantomogram bone density was evaluated

presence of Intra-fragmentary mobility

时间窗: 24 hours

assessed by bi-manual palpation across the fracture site

次要结局

未报告次要终点

研究者

发起方
Hams Hamed Abdelrahman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hams Hamed Abdelrahman

Assistant lecturer of DPH and Clinical statistician

Alexandria University

研究点 (1)

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