An observational study in Impression Technic, Dental, Jaw Relationship and Bruxism, sponsored by Juliana Marotti Großhausen. Enrolling by invitation at 1 site in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-22.
Sponsored by Juliana Marotti Großhausen · Observational
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.
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.
151 studies on the registry are indexed under Bruxism; 39 are open to participants now.
This study's planned enrollment of 73 is below the median of 89 across 55 observational studies indexed under Bruxism.
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Dental Students
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The jaw relation for the Michigan-splint will be performed with wax.
Procedure: Jaw relation · Procedure: Questionnaire
The jaw relation for the Michigan-splint will be performed with JIG.
Procedure: Jaw relation · Procedure: Questionnaire
The quality of the Michigan-splint will be analyzed according to different interventions (wax or jig jaw relation) and a questionnaire that quantify the occlusal contacts of the splint.
The quality of the Michigan-splint will be analyzed according to different interventions (wax or jig jaw relation) and a questionnaire that quantify the occlusal contacts of the splint.
Wax vs JIG Registration
The deviation (in micrometers) between the wax and JIG registration will be measured with the software CloudCompare.
Time frame: From enrollment to the end of treatment at 6 weeks
Questionnaire
In order to analyze the quality of the splints, a questionnaire will be implemented where points will be given (For example: 0=unsatisfactory, 1=corrections needed, 2=satisfactory) for the each topic and answer.
Time frame: From enrollment to the end of treatment at 6 weeks
Plan to share: Undecided — I will share the IPD upon request. All data, study protocol and informed consent of participants can be shared.
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