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3D Titanium Plates for Mandibular Body Fracture Fixation

2026年6月11日 更新者:haitham Aldebass、Cairo University

The Use of 3d Titanium Plates With Two Different Profile Thickness for Open Reduction and Rigid Fixation of Mandibular Body Fracture : Randomised Clinical Trial

Mandibular body fracture pose significant challenges in maxillofacial surgery due to their frequency, potential for functional impairment, and aesthetic concerns. Open reduction and internal fixation (ORIF) using titanium plates and screws have revolutionized the management of mandibular fractures.

Recent advancements in technology have led to the development of patient-specific 3D titanium implants, offering the potential for improved anatomical fit and stability. Moreover, the concept of low-profile implants has gained traction, aiming to minimize soft tissue irritation and enhance patient comfort postoperatively.

研究概览

地位

完全的

详细说明

Facial trauma is common in road traffic accidents (RTA). Due to modernization, increased number of vehicles and failure to follow traffic rules are among various causes of facial trauma. Mandible is one of the frequently fractured bones in RTA. It has been observed that the most common sites of mandibular fracture are angle, body, and ramus.

The incidence of mandibular fracture ranges between 40% and 65% of all facial fractures and so are twice as common as fractures of the midfacial bones. Fractures of the angle of mandible can present with long term disabling sequelae and make up 23%-42% of all fractures in the mandible.

Other than traumatic injuries of the face, there are several factors leading to mandibular body fracture as direct impact or blunt force trauma, indirect trauma to the chin or side of the face, facial fractures, osteoporosis, tumors or cysts in the jawbone, some dental procedures, elderly population, and occupational hazards.

Long term sequel of untreated or poorly treated fractures includes various impairments such as functional, aesthetic, neurological and psychological. The main goal in the treatment of bone fracture is to predictably restore its preinjury anatomical form, with associated aesthetics and function. Techniques for treatment of mandibular fracture have evolved significantly in past decades. These techniques have ranged from closed reduction with maxillomandibular fixation, open reduction with wire osteosynthesis, to open reduction with either rigid internal fixation or adaptive miniplate fixation.

They are best managed by placing one single plate in neutral zone that is sub-apically along with arch bar as tension band. However, in case of severely displaced fractures, inadequate dentition or presence of associated fractures, there are changes in biomechanical vector of forces, which demands for rigid fixation like two plates or load-bearing fixation.

Monocortical plates stabilize the fracture two-dimensionally which can be inadequate fixation in the above-mentioned situations especially in load-bearing area that has led to development of 3D plates. 3D plates are quadrangular in geometry providing stability three-dimensionally due to its design and compact form which counteract against the torsional forces especially in intermental foramen region.

Open reduction and internal fixation (ORIF) using titanium plates and screws have become the standard of care for stabilizing displaced mandibular body fracture, facilitating proper alignment, and promoting optimal healing. However, the optimal design and thickness of these implants remain subjects of debate among maxillofacial surgeons.

研究类型

介入性

注册 (实际的)

18

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Giza Governorate
      • Cairo、Giza Governorate、埃及
        • Dentistery Hospital, Cairo Universiy

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

是的

描述

Inclusion criteria:

  • Age ranging between 20-60 years.
  • Patients with mandibular body fractures requiring open reduction and fixation.
  • Patients with good health (ASA-I and ASA-II) without any contraindication for surgery or anesthesia.

Exclusion criteria:

  • Patients with pre-existing neurological or musculoskeletal disease.
  • Patients with infected fractures.
  • Patients with simultaneous condylar fracture.
  • Patients with regional malignancy.
  • Medically compromised patients.
  • Patients with blood diseases or severe renal disorders. Patients refuse to share in the study

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:Group A (3d titanium plates of 2 mm):
About 9 patients suffered from mandibular fracture treated by using 3d titanium plates of 2 mm thickness.
to compare the 3D titanium plates with two different profile thickness for open reduction and fixation of mandibular body fracture.
其他名称:
  • Open Reduction and Rigid Internal Fixation
有源比较器:Group B (3d titanium plates of 0.7 mm):
About 9 patients suffered from mandibular fracture treated by using 3d titanium plates of 0.7 mm thickness.
to compare the 3D titanium plates with two different profile thickness for open reduction and fixation of mandibular body fracture.
其他名称:
  • Open Reduction and Rigid Internal Fixation

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Treatment of Postoperative pain
大体时间:48 Hours from the operation
Treatment of the pain resulted from using 3d titanium plates with two different profile thickness for open reduction and fixation of mandibular body fracture by using a standardized pain scale.
48 Hours from the operation

次要结果测量

结果测量
措施说明
大体时间
Incidence of postoperative Complications
大体时间:from1 week to 6 months
Secondary outcomes will be evaluated to assess the clinical effectiveness and safety of using 3D titanium plates with different profile thicknesses in the fixation of mandibular body fractures (as infection, malocclusion, and hardware-related complications).
from1 week to 6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Mohamed Atef, Professor、of Oral and Maxillofacial Surgery, Faculty of Dentistry - Kasr Al-Aini

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年12月15日

初级完成 (实际的)

2025年12月15日

研究完成 (实际的)

2026年2月15日

研究注册日期

首次提交

2026年6月11日

首先提交符合 QC 标准的

2026年6月11日

首次发布 (实际的)

2026年6月16日

研究记录更新

最后更新发布 (实际的)

2026年6月16日

上次提交的符合 QC 标准的更新

2026年6月11日

最后验证

2025年2月1日

更多信息

与本研究相关的术语

其他研究编号

  • Mandibular Fracture Fixation

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

是的

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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