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临床试验/NCT02181868
NCT02181868Approved For Marketing不适用

Comparison of Biodegradable and Titanium Fixation Systems in Mandibular Symphysis or Parasymphysis Solitary Fractures

Louqiang Zhang1 个研究点 分布在 1 个国家开始时间: 2008年1月最近更新:
适应症

试验速览

阶段
不适用
状态
Approved For Marketing
发起方
试验地点
1

研究概览

简要总结

The mandible bears a wide range of mechanical load from the contraction of masticatory muscles, and has a significant function in normal chewing movements. Mandibular fractures are the most common maxillofacial fractures, accounting for 40%-71% of all maxillofacial fracture cases with an average of 62%. The etiology of mandibular fractures mainly includes assaults, road traffic accidents (RTAs), falls, and sports injuries. Although a wide variance exists in the reported percentage of anterior mandible fractures, aggregate analysis approximates these fractures at 17% of all mandibular fractures. The rigid internal fixation (RIF) technique has become a common treatment for mandibular fractures, in which titanium plates are used in the operation. Some patients have to remove the titanium plates in a second operation following bone healing because of sequelae, such as stress shielding. Biodegradable plates and screws have been developed to eliminate the problems associated with titanium fixtures. In this study, we aim to compare the clinical performance between biodegradable and titanium fixation systems after 12 months of follow-up in fixation of mandibular symphysis and parasymphysis solitary fractures. We also investigate the stress distributions of biodegradable and titanium fixation systems at mandibular symphysis solitary fracture on the conditions of intercuspal position, labial teeth occlusion, and premolar and molar occlusion using finite element analysis.

研究设计

研究类型
Expanded Access

入排标准

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

入选标准

  • Undisplaced and displaced mandibular symphysis and parasymphysis solitary fractures conducted at the department of Oral and Maxillofacial (OMF) Surgery, Tianjin Medical University General Hospital

排除标准

  • The exclusion criteria were comminuted fractures
  • Connective tissue diseases
  • Patients under the age of 18 and over the age of 60

研究者

发起方
Louqiang Zhang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Louqiang Zhang

Department of Stomatology

Tianjin Medical University General Hospital

研究点 (1)

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