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临床试验/NCT06377475
NCT06377475Enrolling By Invitation不适用

Herstellung Und Eingliederung Von Michigan-Schienen Durch Zahnmedizinstudierende: Eine Qualitative Und Quantitative Studie

Juliana Marotti Großhausen1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2024年3月8日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
73
试验地点
1
主要终点
Wax vs JIG Registration

研究概览

简要总结

The aim of this study is to investigate the potential effects of different jaw relation determination (KRB) techniques on the fabrication of Michigan splints, in particular by comparing conventional methods with a wax plate and the use of an anterior jig. All materials and methods for the fabrication of the Michigan splint are already part of the curriculum of the Clinic for Dental Prosthodontics for first-year Master-students. Therefore, we intend to conduct a retrospective study (for the 2023 cohort) and a prospective analysis of the data (for the 2024 and 2025 cohorts). Questionnaires, models and intraoral scans will be used to evaluate the efficacy and precision of the different KRB methods as well as the fabrication process of the Michigan splint.

详细描述

Since its development in the 1960s as a modification of the Sved-biteplane constructed in Scandinavia, the Michigan splint has gained worldwide recognition and can now be described as the gold standard of treatment with stabilization splints for myoarthopathies. The use of stabilization splints - as confirmed in an S3 guideline published by the Association of the Scientific Medical Societies in Germany (AWMF) in 2019 - is classified as a recommendable and, if necessary, reversible therapeutic measure for the treatment of bruxism. As part of a systematic review, additional causes were identified in addition to the seven already known central risk factors for bruxism. In addition to factors such as emotional stress and anxiety disorders, further psychological disorders were added as part of the literature review. Against this background of a predominantly psychologically determined aetiopathogenesis, acceptance of the splint by the patient could represent an important component of successful treatment for bruxism, for example in terms of increased patient compliance. Sufficient evidence-based studies that specifically investigate a possible connection between the type of fabrication of the Michigan splint and its acceptance by the patient are still lacking. The Michigan splint is a proven method for the treatment of patients diagnosed with bruxism. In the conventional method, the KRB of the Michigan splint is fabricated using the wax technique, which can lead to inaccuracies in registration due to its material properties. With the advancement of digital technology, the use of intraoral scanners is becoming more common in dental practices. In these cases, KRB can be performed with a jig using a material with higher precision than wax. Furthermore, the KRB can be scanned with the JIG without interfering with wax. To date, no studies have been conducted comparing the quality of the Michigan splint with these two KRB methods. For the fabrication of the jig, the condyles must serve as support points, which is why it is not possible to perform in vitro studies with the JIG.

The primary objective of this study is to descriptively analyze the quality of Michigan splints fabricated by dental students. The parameters examined relate to the fit, extension and function of the splint. Likewise, the common KRB methods (wax plate and anterior jig) are to be compared in order to identify any discrepancies and thus consequences in the fabrication of the splint. The data obtained from the scans will be analyzed and points compared in order to compare possible differences between the various bite registration methods. The secondary aim of this study is to analyze and possibly improve the fabrication process of Michigan splints in the context of dental student education.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

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

  • Dental students in the first year of their Master's degree
  • 18 years and older, gender independent
  • Ability to give informed consent, documented by signature

排除标准

  • Inability or contraindications (e.g. dental pain, dental mobility, generalized periodontitis, removable denture wearers, acute infection) to undergo the procedure under study
  • Inability to follow the procedures of the study, e.g. due to language problems, depression or mental disorders
  • Students who do not consent to the analysis of the data

结局指标

主要结局

Wax vs JIG Registration

时间窗: From enrollment to the end of treatment at 6 weeks

The deviation (in micrometers) between the wax and JIG registration will be measured with the software CloudCompare.

次要结局

  • Questionnaire(From enrollment to the end of treatment at 6 weeks)

研究者

发起方
Juliana Marotti Großhausen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Juliana Marotti Großhausen

PD Dr. med. dent.

University of Basel

研究点 (1)

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