跳至主要内容
临床试验/NCT05755022
NCT05755022招募中不适用

Reverse Engineering Utilizing the 3D Photogrammetry Technique Versus Commercial Scanners for Accurate Repositioning of the Maxilla After Le-fort I Osteotomy for Correction of the Dentofacial Deformity (Randomized Controlled Clinical Trial).

Cairo University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2023年1月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
24
试验地点
2
主要终点
Accuracy of maxillary segment repositioning

研究概览

简要总结

Current advances in the three-dimensional virtual surgical planning (3D-VSP) of the orthognathic surgery have brought newer insights, enormous benefits and have become an indispensable aid for diagnosis, treatment planning and outcome assessment especially in the management of dentofacial deformities.

The extent to which the planned surgical outcome could be achieved is dependent on the surgeon's ability to accurately transfer the planned movements to the real surgical field. Accurate repositioning of the maxilla after Le-fort I osteotomy is of utmost importance for an esthetic and functional purposes.

The goal of this interventional study is to compare the 3D photogrammetry technique versus the commercial scanners for accurate repositioning of maxillary segment after le-fort I osteotomy using the reverse engineering technology.

The main question it aims to answer; Is the utilization of the 3D Photogrammetry technique affect the accuracy of maxillary segment repositioning after le-fort I osteotomy compared with the commercial scanners?

详细描述

In orthognathic surgery, the precise repositioning of the maxilla after Le-fort I osteotomy is a challenging procedure because there is no room for error in this step if the procedure is to be accurate.Transferring the virtual position of the maxilla to the real operative field via the intermediate occlusal splint fabrication, which is the most commonly used method, ensures only the intended position of the maxilla in the transverse, sagittal planes and cannot guarantee its vertical position in relation to the skull base. The vertical maxillary repositioning usually relies on a manual intraoperative adjustment using either intra-oral or extraoral reference points and affected by the degree of autorotation of the mandible that occur as a result of the surgical maneuvers operated by the surgeon intraoperatively. This makes the reliability of and precision in transferring virtual surgical plans to the operative field is still unpredictable defeating the main advantages of 3D technology. Moreover, it can be time consuming.

Many attempts to obtain a more reliable method for positioning the maxilla, independent of the mandible, have been made such as a series of maxillary reposition templates, patient specific osteosynthesis plates and navigation assisted surgery and it yielded satisfactory results. Also, intraoperative occlusal-based devices that transfer virtual surgical planning to the operating field for repositioning of the osteotomized segments was introduced. Most of the time the surgeon looks for new modalities to optimize his surgical results, simplify the execution of the surgery and at the same time to meet the patients' demands and expectations.

Photogrammetry is a versatile, readily available technique that allows for creating a 3D model from 2D photographs in an affordable manner and with a high levels of precision equivalent to other tools that are generally more expensive and less available such as a commercial scanner. It has several applications in the life and earth sciences, medicine, osteological studies, architecture, topography, archaeology, crime scene investigation, cinematography, and engineering. So, the present study aims to assess the accuracy gained and the feasibility of using this technique for transferring the virtually intended maxillary segment position to the real operation compared with the commercial scanners.

Trial design:

Randomized Controlled Clinical Trial. Parallel group, two arm with allocation ratio 1:1.

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)

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

  • Age range of 18-60 years.
  • Patients requiring one-piece Le-Fort I osteotomy as part of their orthognathic surgery for the correction of dentofacial deformity.
  • Patients should be free from any significant medical condition that could affect or hinder normal healing and predictable outcomes.
  • Patients with no signs or symptoms of temporomandibular joint disorders.
  • Patients who will be committed to the follow up period and agree to sign the informed consent.

排除标准

  • Patients requiring segmental Le-Fort I osteotomy.
  • Patients with previous history of orthognathic surgery.
  • Patients with cleft lip and palate.
  • Patients with skeletal deformities owing to trauma or tumor resection.
  • Patients with any intra-bony lesions or infections.
  • Patients with temporomandibular joint disorders.

结局指标

主要结局

Accuracy of maxillary segment repositioning

时间窗: Outcome will be assessed with immediate postoperative Computed Tomography at one week.

The actual postoperative 3D maxillary segment position will be compared with the preoperative virtual maxillary positioning by: A) Linear and angular measurements: Some specific reproducible points and planes will be identified on the 3D virtual model, and then on the post-surgery model. The distance from points to planes will be calculated on each model and the difference between these distances is to be registered as the error of accuracy. B) Color-coded map: Different colors show the distance between the surfaces, with green color usually showing the lack of distance, meaning zero error of accuracy. This method of assessing changes in 3D surfaces involves measuring the point-to-point distance of one mesh (VSP - 3D model reference) to the second mesh (Postoperative - 3D model test) and generating a color distance map.

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

Dina Yacoub Girgis

Assistant Lecturer

Cairo University

研究点 (2)

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