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临床试验/NCT04353635
NCT04353635Unknown不适用

The Assessment of Prediction of Soft Tissue Changes Following the Surgical Correction of Dento-facial Deformities Using Dolphin 3D Software Package.

Ain Shams University0 个研究点目标入组 12 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
12
主要终点
The difference between prediction and actual postoperative

研究概览

简要总结

Patients with class III dentofacial deformity who are in need of surgical correction are now able to see the potential changes to their faces before the actual operation. Dolphin 3d is one of the few software packages that is used for orthognathic planning and prediction of soft tissue changes. The direct effect of the prediction procedure over patient's and surgeon decisions makes it important to guarantee a high level of accuracy of operational results prediction. This study is designed to investigate the accuracy of Dolphin 3d software for the prediction of postoperative soft tissue changes following specific surgical procedure which is the combined maxillary advancement and mandibular setback, commonly used for correction of class III facial deformity cases. The study data will be collecting retrospectively. The difference between the pre-operative soft tissue prediction and the 6-month postoperative results will be analysed. The results of this study will help to determine whether this software package is accurate enough to be considered as a surgical assistance tool helping both surgeons and patients in treatment planning and decision-making procedure respectively.

详细描述

The study will employ the pre-existing CBCT images routinely captured for orthognathic surgery patients in Glasgow dental hospital and school.

The CBCT scans of class III patients who undergone maxillary advancement with minimal or without impaction and mandibular setback will be identified.

The preoperative and 6 months postoperative CBCT images will be anonymised The surgical planning and soft tissue prediction will be performed on the preoperative images using Dolphin3d software.

The resultant soft tissue 3D model will be superimposed on the actual postoperative soft tissue model.

Analysis of the difference between the prediction and the actual postoperative will be performed to quantify the difference between them in order to assess the accuracy of the software prediction.

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 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who have class III facial deformity to be corrected using bimaxillary orthognathic surgery.
  • No medical problems that might interfere with general anesthesia or interfere with bone and soft tissue healing.

排除标准

  • There are craniofacial anomalies including cleft lip/palate,
  • Patient have previous maxillofacial operations or facial scars,
  • Correction mandates multi-segment Le Fort I osteotomies,
  • There are orthodontic appliances in place at the time of T1 records.
  • Genioplasty is recommended for deformity correction.
  • There is facial Asymmetry.

结局指标

主要结局

The difference between prediction and actual postoperative

时间窗: 6 months

The difference between prediction and actual postoperative. The distance between the corresponding vertices will be displayed as a colour scale in milli-meter and will be analysed in the individual dimension of space (x, y and z) using in-house software and each dimension will be displayed as a colour coded distance map.

次要结局

  • The distance between the corresponding vertices(6 months)

研究者

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

Nehal Ibrahim Ahmed Shobair

Key Investigator

Ain Shams University

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