跳至主要内容
临床试验/NCT07373184
NCT07373184招募中不适用

Three-dimensional Virtual Planning of Total Temporomandibular Joint Replacement Using Standardized Prosthesis.

Lund University Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年2月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Measurements in preoperative radiographs for re-evaluation of possibilities for virtual surgical planning on standardized total TMJ reconstruction.

研究概览

简要总结

A total TMJ replacement surgery is currently planned based on the X-ray appearance of the facial X-ray. It is now possible to use either an individually designed TMJ prosthesis or a prosthesis with a standard appearance. It is a significantly higher cost for treatment with an individually manufactured prosthesis, but it also provides the opportunity for virtual planning of the positioning of the jaws and prosthesis.

By using a planning program with treatment simulation through the use of our own virtual models for standard prostheses, virtual planning of jaw and prosthesis positioning is possible even with a standardized temporomandibular joint prosthesis. In this way, the advantages of virtual planning are partly brought to the patients at a much lower price.

This project aims to virtually plan treatment for patients with standardized temporomandibular joint prosthesis. Patients eligible for this study are included retrospectively (have already been treated). Their X-rays will be used for treatment planning and for comparison with the treatment outcome of previous TMJ treatment.

The study will analyze the possibilities of the standardized prostheses to provide the same positions, temporomandibular joint replacements and movements of the jaw as an individual temporomandibular joint prosthesis has. This is done by measuring the planned positions of standardized temporomandibular joint prostheses compared to the treatment outcome shown by previous postoperative X-ray examinations.

The study aims to clarify the possibilities of a simpler and less expensive technology, standardized temporomandibular joint prostheses, to achieve the same good treatment outcome as a more costly technology. This with the same possibilities for treatment planning and use that the existing, more expensive technology, individual temporomandibular joint prostheses, has today.

详细描述

Aim and objectives

The aim of the present study was to evaluate the possibility to perform patient specific treatment planning with the use of standardized total TMJ prosthesis on previously performed treatment with total TMJ replacement and occlusal adjustment due to a severe malocclusion. The objectives were surgical feasibility of virtual planning on standardized TMJ prosthesis measuring virtual possible maximal interface (mm2) between prosthesis and bone, possible maximal number of fixation screws and possibility to centre the mandibular part in the fossa part. The outcome measures were surgical movements to correct a severe malocclusion using standardized TMJ prosthesis.

Survey of the field

A total replacement of the temporomandibular joint (TMJ) has been successfully offered to patients with severe joint disease since more than three decades. In the early years, the surgical technique has been judged as complex and similar to other joint prosthesis the TMJ prosthesis has been burdened with some risk of complications. With emerging technologies, within computer science, biomedical design, and biocompatible materials the treatment option has been possible to use in a wider perspective. Thus, a broader patient spectrum has been possible to rehabilitate with TMJ prosthesis. Today, not only joint-related pathologic conditions are offered joint reconstruction, but also congenital deformities like Hemifacial Microsomia and Dentofacial deformities. Furthermore, the advancement of the treatment quality has enabled patients with severe joint-pathology, like Juvenile Idiopathic Arthrosis with a subsequent severe malocclusion and facial deformity, to have a total rehabilitation with both normalization of the joint function together with improved facial appearance and bite function.

However, in many of these severe cases the corrections of the facial structures simultaneously with a joint replacement provides the surgeon with a complex treatment-planning phase. Frequently, the movements need to be planned and simulated virtually to evaluate both the best positioning of segments and joint components and to manufacture surgical indexes and cutting templates. The invention of patient specific solutions (PSI) have made hardware design based on 3D radiological imaging and soft tissue predictions possible. Patient specific total TMJ prosthesis provided the surgeon with virtual planning, cutting guides, occlusal splints and well-fitted alloplastic TMJ components. However, this came with additional costs and the advantage of customized prosthesis over standardized have been debated. Attempts have been made to retrospectively compare customized with standard prosthesis, but this fare no prospective or RCT have been published. Presently, this lack of prospective comparisons leaves the evaluation with only retrospective and observational comparisons. This results in a risk of bias because of a difference in treatment indication between the compared treatment modalities. Thus, the outcome from a retrospective comparison will be coloured by a selection bias with the indication for treatment as a confounding factor.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with severe pathology in the temporomandibular joint.
  • Previously treated with TMJ prosthesis at the department of Oral and Maxillofacial Surgery, Skåne University Hospital, Lund, Sweden.
  • Treatments performed during year 2010 to 2025.

排除标准

  • - Patients with additional surgical treatment of the TMJ after total TMJ replacement.

结局指标

主要结局

Measurements in preoperative radiographs for re-evaluation of possibilities for virtual surgical planning on standardized total TMJ reconstruction.

时间窗: During 2026 retrospective virtual measurement on previous radiographs will be performed. Because patient treatments were performed during 2010 to 2025 the measurements will be performed 1 to 16 years after the recordings were performed

Measurements in images from virtual planned standardized TMJ prosthesis will include the following variables: * Maximal interface between bone tissue and prosthesis surface (mm2) * Size Fossa component * Size Mandibular component * Maximal number of fixation screws * Centre the mandibular part in the fossa part. * Angle between fossa and mandible part (frontal) * Angle between fossa and mandible part (sagittal)

次要结局

  • Recorded surgical movements to correct a severe malocclusion.(During 2026 retrospective virtual measurement on previous radiographs will be performed. Because patient treatments were performed during 2010 to 2025 the measurements will be performed 1 to 16 years after the recordings were performed.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验