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临床试验/NCT06714747
NCT06714747招募中不适用

Soft Tissue Prediction in Orthognathic Surgery by Making Anatomically Accurate Virtual Model

IRCCS Azienda Ospedaliero-Universitaria di Bologna1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年1月11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
10
试验地点
1
主要终点
primary outcomes

研究概览

简要总结

The role of orthognathic surgery in the correction of dento-skeletal dysmorphies, whether they are Class II or Class III or asymmetries, is to improve both the function and aesthetic appearance of thepatient. Both aspects are equally important to achieve optimal results.

When the surgeon plans the surgery, he or she must therefore take into account the effects that bone displacements will have at the level of the soft tissues directly involved in the surgery, such as the maxilla and mandible. Traditionally, such surgery consists of an orthodontic presurgical phase1,2

.

详细描述

The role of orthognathic surgery in the correction of dento-skeletal dysmorphies, whether they are Class II or Class III or asymmetries, is to improve both the function and cosmetic appearance of the patient. Both aspects are equally important to achieve optimal results.

When the surgeon plans the surgery, he or she must therefore take into account the effects that bone displacements will have at the level of the soft tissues directly involved in the surgery, such as the maxilla and mandible. Traditionally, such surgery consists of an orthodontic presurgical phase1,2

.

The current knowledge of facial aesthetics and its changes consequent to orthognathic surgery is given by studies mainly carried out in 2-dimensions, performed using radiographs (teleradiographs of the skull in PA and LL) and standard photographic material, on which two-dimensional cephalometric and anthropometric studies have been performed. A first fragility, related to less realism, lies in the fact that these represent objects in 2-dimensions when the human body is a structure in 3-dimensions, as well as the chiurgy that is going to be performed and the resulting changes are in the 3-dimensions of space. A second lesser precision of this method of records acquisition is the substantial impossibility of obtaining comparable material in the preoperative and postoperative periods, due to the understandable difficulty of homogeneous acquisition of the records themselves: photographs and radiographs . Recent advances in technology have generated a wide variety of 3-D methods that allow acquisition in the 3-dimensions of space of both surface structures and skeletal bases. These methods include: digital stereophotogrammetry, CT, MRI, and ECO-3D.

This new knowledge has then enabled 3D studies that were previously done in 2D: cephalometry, morphological analysis of the face

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing orthognathic surgery and preoperative radiographic study with CBCT and MRI
  • Patients with age > or = 18 years old
  • Obtaining informed consent
  • Patients with preoperative teleradiography and orthopantomography

排除标准

  • patients with cleft lip-palate, facial malformations and/or syndromes (syndromes with involvement of the cephalic extremity, such as sd of Apert. Cropuzon, Ofeiffer, Treacher Collins)
  • patients who have undergone application of Medpor prostheses or who have undergone ancillary procedures (lipofilling, fillers, volumetric facial augmentations with insertion of polyethylene ketone prostheses)

结局指标

主要结局

primary outcomes

时间窗: 18 months

Implementation of a virtual three-dimensional model of the face already provided for care procedure that is anatomically accurate in predicting soft tissue displacements following orthognathic surgery. This model will include the biomechanical characteristics of the facial muscles and skin. In particular, the sensitivities of different areas of the face (nose, cheeks, and upper lip) that are particularly important in orthognathic surgery will be evaluated in response to variation in the biomechanical properties of the muscles (Poisson's coefficient and Young's modulus).

次要结局

  • secondary outcomes(18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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