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临床试验/NCT03869021
NCT03869021已完成不适用

Technical Notes on Novel Technique and Step by Step Construction of Computer Guided for Mandibular Distraction Osteogenesis

Yasser Mohamed Nabil Ahmed Khirat El Hadidi1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2015年12月30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
Standard cephalometric parameters of cosmetic improvement will be assessed in Degree (0) unit

研究概览

简要总结

Objectives: Distraction Osteogenesis is an integral part in management of mandibular defects associated with Hemifacial Microsomia (HFM) and post-ankylotic mandibular defects. The most difficult part in distraction osteogenesis is the prediction of distraction vector and risk of injury to vital structures as inferior alveolar. The current study aimed to present Three-Dimensionally Constructed Computer Guided Splints in Distraction Osteogenesis to get an ideal vector and minimal risk of vital structures injury.

Methods: The study presents computer-guided distraction osteogenesis surgery using prefabricated splints.

详细描述

The current study was performed on a case control trial of patients complaining of hemifacial microsomia.. The research was reviewed by the ethical committee of the authors institute (approval number: 392, date: 30/12/2015). Written informed consent for the case to be published (incl. images, case history and data) was obtained from the patients for publication of this case report, including accompanying images In order to accurately analyse the patients' condition and formulate an optimal treatment plan, a pre-operative CBCT scan was performed using i-CAT CBCT scanner (Imaging Sciences International, Hatfield, PA, U.S.A).

Each patient was positioned in the machine and imaged at the same manner according to the recommendations of CBCT manufacturer. The Frankfurt plane was positioned parallel to the horizontal plane and the midsagittal plane was perpendicular to the horizontal plane.

The CBCT scan was required to fulfill the following criteria:

  • Showing the full bony facial structures, extending from at least the inferior border of the mandible to the supraorbital ridge.
  • CBCT scan should be free from any motion artifacts.
  • Patient biting on cotton rolls in order to free the occlusion.
  • A scan of optimum quality and resolution. (0.25 mm voxel size) IV. Virtual Treatment Planning
  • The data from the CBCT scan were exported from the i-CAT Vision software in DICOM format, which was in turn imported into Mimics Medical 19.0 software (Materialise NV, Technologielaan 15, 3001 Leuven, Belgium) for virtual treatment planning.
  • Using the "Thresholding" tool, the range of gray value sets is chosen to highlight the mineralized structures and separate them from the rest of soft tissue structures in the scan creating a new mask.
  • Using the "Calculate 3D" tool on the new mask, a 3D rendering of the facial mineralized structures is created and is then refined using the "Smoothing" and "Wrap" tools.
  • In order to properly orient the patient's head position, analyze the deficiencies, and standardize the planning process, the Frankfort Horizontal plane and the Midsagittal plan were constructed. Frankfort Horizontal Plane was defined by marking the right and left Orbitale, and the Porion of the non-affected side. The Midsagittal plane was defined by marking the Sella, the Nasion, and the Anterior Nasal Spine.
  • Using the "Multiple Slice Edit" and "Region Growing" tools when needed, the jaws are separated and the mandible and maxilla are segmented separately.
  • Using the "Distraction Wizard", an appropriate distraction type is selected. A distractor is selected and placed on the proposed site for distraction. The osteotomy and vector are visualized and the distractor is activated. This process is repeated until the final outcome is satisfactory. The ideal final outcome is when the canted occlusal plane is corrected and the mandibular midline is coincident with the facial midline simultaneously.
  • Using the "Cylinder" tool in the "Medcad" menu, virtual distractor pins and osteotomy disk are drawn to match our selected custom-made distractor. The number of pins, their size, and orientation differed according to the vital structures in each distraction site. Hence, custom-made distractors were used. Guide fixation screws are also added to provide further retention for the guide when needed. The fixation screws, osteotomy and distractor pins are placed so as to avoid injury to any vital structures as the Inferior Alveolar Nerve, tooth buds, and dental roots .
  • Using different Boolean operation, the body of the final guide is designed to fit over the bones and teeth and incorporate the different distractor components. It is then exported into STL format.
  • The exported STL file is printed with Formlabs Form 2 stereolithography (SLA) 3D printer (Formlabs Inc. Somerville, MA 02143 USA) using Clear Photopolymer resin (FLGPCL02). The finished printed model is then checked for fit with the distractor.
  • Prior to surgery, the guide is submerged in a basin containing 2.4% activated glutaraldehyde solution (Cidex) for 20 minutes for high level disinfection.

Surgical Procedure

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Care Provider)

盲法说明

Single blinding

入排标准

年龄范围
5 Years 至 25 Years(Child, Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •Patients free from any disease affecting bone formation of both sexes was included in the study.
  • •Patients younger than 25 years old.
  • •Patients included in the study were hemifacial microsomia
  • •Distraction range was between 15-20 mm.

排除标准

  • •The presence of uncontrolled systemic disease.
  • •Previous radiotherapy on head and neck region.
  • •Chemotherapy within the past 12-month period.
  • •An active infection at the distraction site.

研究组 & 干预措施

Computer guided surgery

Active Comparator

A surgical guide is 3d printed to guide through the surgery, the patients of this group will have the distraction surgery by a guide designed by Mimics 19.0, Materialise NV,Belgium

干预措施: 3D printed surgical guide constructed (Other)

No surgical guide (free hand surgery)

Other

control group added to investigate the effect of surgical guide

干预措施: free hand surgery (Other)

结局指标

主要结局

Standard cephalometric parameters of cosmetic improvement will be assessed in Degree (0) unit

时间窗: 6 months

The surgery of distraction osteogenesis is unpredictable the aim of use of computer planning is to make the surgery predictable to improve cosmetic results. the results will be by fixed radio graphic parameters as SNA, ANB to evaluate improvement in mandibular position, mandibular plane angle and smile orientation for occlusal cant assessment, H-angle and position of H-line to assess the retrognathia of chin all measurment will be done in degree unit

次要结局

未报告次要终点

研究者

发起方
Yasser Mohamed Nabil Ahmed Khirat El Hadidi
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yasser Mohamed Nabil Ahmed Khirat El Hadidi

Assistant Lecturer

Ain Shams University

研究点 (1)

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