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临床试验/NCT06898736
NCT06898736已完成不适用

Evaluation of Accuracy of Three-Dimensional Printing and Three-Dimensional Miniplates in Treatment of Anterior Mandibular Fractures: A Prospective Clinical Study

Mansoura University3 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2021年10月10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
入组人数
15
试验地点
3
主要终点
Bone density was measured by Hounsfield units (HU) measured on CT images

研究概览

简要总结

The primary objective of this study was to evaluate the accuracy of virtual reduction and the prebending of the 3D miniplates on printed models for fixation of anterior mandibular fractures. The secondary objective is to evaluate the bone healing of anterior mandibular reduction.

详细描述

The mandible is the largest and most prominent bone in the maxillofacial region. Facial fractures frequently involve the mandible. Rigid internal fixation combined with maxillomandibular fixation is the standard surgical procedure for treating mandibular fractures. Maxillofacial surgery currently makes extensive use of digital technology in areas like surgical navigation, titanium plate preforming technology, and 3D digital guide plate technology.

Monocortical miniplates that are easily adaptable are used in Champy's semi-rigid fixation technique, along with an "ideal osteosynthesis line" to counteract the developing masticatory forces. The location of the bone plate fixation must provide the fixation method that is most stable in relation to the line of tension at the base of the alveolar process. One plate is often used for fractures that are posterior to the foramen, and two plates are typically used for fractures anterior to the foramen.

Due to muscles working against each other, the anterior mandible fractures are subject to strong torsional forces. Some researchers have suggested using the three-dimensional (3D) miniplates as a viable option for fixation.

To ensure successful osteosynthesis with a minimally invasive approach, three-dimensional (3D) miniplate systems can be used. The system comprises two miniplates joined by interconnecting crossbars and fixed to the bone with monocortical screws. When placed in the fracture line, the 3D miniplate system ensures fracture stabilization, regardless of plate thickness and geometry. The placement of screws in a square pattern on either side of the fracture creates a solid platform that increases resistance to twisting and rotation of the longitudinal axis of the plate.

The stability of occlusion after using 3D miniplates may be due to the box-like configuration, providing rigid fixation of fractures that prevent Buccolingual splaying and gap formation at the fracture site and subsequent occlusal discrepancy; this is the advantage of 3D miniplates over 2D miniplates.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
15 Years 至 50 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Recent anterior mandibular fractures (within one week).
  • •Adult patients of both genders (18-50 years old).
  • •Systematic healthy patients.
  • •Radiographic evidence of anterior mandibular fracture.

排除标准

  • •Medically compromised patients contraindicated for general anaesthesia and bone surgery.
  • •Comminuted fractures.
  • •Bilateral anterior mandibular fractures.
  • •Previously treated fractures.
  • •Pathological fractures and bone diseases.

研究组 & 干预措施

virual plan before and after mandibular fracture fixation

Experimental

virual plan before and after mandibular fracture fixation and 3D miniplate fixation

干预措施: 3d miniplate (Device)

结局指标

主要结局

Bone density was measured by Hounsfield units (HU) measured on CT images

时间窗: 3 months

The length and width of the mandible were measured using 3D CT scan with digital callipers in millimetres.

mandible dimensions

时间窗: 3 months

Mandibular length and width were measured using 3D CT scan with digital callipers in millimetres.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mazen Tharwat Abou Elkhier

Mazen Tharwat Abou Elkhier, principle investigator

Mansoura University

研究点 (3)

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