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临床试验/NCT05522348
NCT05522348Unknown不适用

Stability of Two Different Designs of Patient Specific Osteosynthesis "One Piece VS Two Piece" For The Fixation of LeFort 1 Osteotomy in Maxillary Orthognathic Surgery A Randomized Clinical Trial

Cairo University2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2022年9月5日最近更新:
适应症

试验速览

阶段
不适用
入组人数
34
试验地点
2
主要终点
Stability of the new maxillary position

研究概览

简要总结

A comparison of the stability of two different designs of patient specific fixation devices for the performance of splintless computer guided le fort 1 osteotomy in orthognathic surgery workflow for the correction of a variety of dentofacial deformities

详细描述

• Intervention Group: -

Pre-Operative Virtual planning:

After CT examinations, further processing of the DICOM files (Digital Imaging and Communications in Medicine) will be performed using the specialized DICOM image processing software and reconstructed 3D models of the skull will be made. Stone models will be scanned using an optical scanner and stereolithographic files will be imported. Registration of the STL files with the skull model will create a composite model suitable for the construction of necessary devices. These 3D models will be used to design the custom-made cutting guides and fixation devices. The final STL files will be sent to the lab to be milled/printed.

Surgical procedure:

Routine site preparation regarding L.A injections and surgical site disinfections. A maxillary vestibular incision will be made from the maxillary second premolar on one side to the contralateral tooth. The incision will be made 5 mm above the mucogingival junction to leave an adequate cuff for closure. A full thickness mucoperiosteal flap will be reflected to expose the anterior and lateral maxillary walls. Superiorly the reflection exposes the pyriform rim, lateral nasal wall and the infraorbital nerve. Moving backwards, exposure of the zygomatico maxillary buttress is done followed by the maxillary tuberosity and finally the pterygomaxillary junction. The cutting guides will then be placed on the exposed maxilla. The cutting guides will have holes designed in them corresponding to the position of the fixation screws and a slot marking the level of the level of the Le fort 1 osteotomy which will be made using a reciprocating saw. The osteotomy is initiated and the cutting guide is removed.

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
Double (Participant, Outcomes Assessor)

盲法说明

The participants and the outcome assessor will be blinded to the intervention, however the primary investigator will not be blinded as he performs the surgical procedure.

入排标准

性别
All
接受健康志愿者

入选标准

  • Adult patients with dentofacial deformity: skeletal class 2, class 3, vertical maxillary excess, Facial asymmetry.
  • Patient seeking definitive surgical correction and refusing orthodontic camouflage.
  • Maxillary impaction, advancement and rotations.
  • Highly motivated patients.
  • Good oral hygiene.
  • Patients willing for the surgical procedure and follow-up, with an informed consent

排除标准

  • Medically compromised patients
  • Uncooperative patients
  • Poor oral hygiene
  • Periodontal diseases
  • Patients with no desire for surgical correction
  • Patients with any diseases that compromise bone or soft tissue healing Patients with local pathology that interfere with the bone healing

结局指标

主要结局

Stability of the new maxillary position

时间窗: 4 months

Primary outcome will be the positional stability of the repositioned maxilla which will be measured via CT scan by superimposing the postoperative maxillary segment obtained from a 4 months postoperative CT

次要结局

  • Intra-operative time(Intra-operative)
  • Patient satisfaction using Visual Analogue Scale(3 months)

研究者

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

Shady Medhat Sabet Shaker

Master's degree candidate

Cairo University

研究点 (2)

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