Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06377475
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-22
First Post:
2024-03-18
Brief Title:
Fabrication and Insertion of Michigan Splints by Dental Students
Sponsor:
Juliana Marotti Großhausen
Organization:
University of Basel
Study Overview
Official Title:
Herstellung Und Eingliederung Von Michigan-Schienen Durch Zahnmedizinstudierende Eine Qualitative Und Quantitative Studie
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2024-00148 | REGISTRY | EKNZ | None |