Impression Technic, DentalNCT06377475
Fabrication and Insertion of Michigan Splints by Dental Students
An observational study of Impression Technic, Dental and Jaw Relationship, run by Juliana Marotti Großhausen at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Impression Technic, Dental, Jaw Relationship, Bruxism
- What is being tested?
- Jaw relation and Questionnaire
- Type of treatment
- Surgery or procedure
- How many people
- 73 participants
- Where
- 1 siteSwitzerland
- Study dates
- 8 Mar 2024to Dec 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Dental Students
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Herstellung Und Eingliederung Von Michigan-Schienen Durch Zahnmedizinstudierende: Eine Qualitative Und Quantitative Studie
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.
Read the 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.
- Conditions
- Impression Technic, Dental, Jaw Relationship, Bruxism
- Being tested
- Jaw relation, Questionnaire
- Keywords
- Bruxism, Jaw Relationship, Impression Technic
- Medical subject headings
- Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jaw relationProcedure or surgery
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.
QuestionnaireProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Wax registration | The jaw relation for the Michigan-splint will be performed with wax. Receives: Procedure: Jaw relation; Procedure: Questionnaire | |
| JIG registration | The jaw relation for the Michigan-splint will be performed with JIG. Receives: Procedure: Jaw relation; Procedure: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wax vs JIG Registration
The deviation (in micrometers) between the wax and JIG registration will be measured with the software CloudCompare.
Measured: From enrollment to the end of treatment at 6 weeks
Secondary outcomes (1)
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.
Measured: From enrollment to the end of treatment at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start8 Mar 2024
- Primary completionMay 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impression Technic, DentalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 73 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Juliana Marotti Großhausen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Juliana Marotti Großhausen, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06377475
- Sponsor's protocol ID
- 2024-00148
- Other IDs
- 2024-00148
- Status last verified
- Apr 2024
- First submitted
- 18 Mar 2024
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I will share the IPD upon request. All data, study protocol and informed consent of participants can be shared.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Herstellung Und Eingliederung Von Michigan-Schienen Durch Zahnmedizinstudierende: Eine Qualitative Und Quantitative Studie
- ClinicalTrials.gov ID
- NCT06377475
- Acronym / sponsor ID
- 2024-00148
- Conditions
- Impression Technic, Dental, Jaw Relationship, Bruxism
- Keywords
- Bruxism, Jaw Relationship, Impression Technic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- Juliana Marotti GroßhausenUniversity, hospital or other
- Study start
- 8 Mar 2024 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wax registration | – | Procedure: Jaw relation, Procedure: QuestionnaireThe jaw relation for the Michigan-splint will be performed with wax. |
| JIG registration | – | Procedure: Jaw relation, Procedure: QuestionnaireThe jaw relation for the Michigan-splint will be performed with JIG. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Dental Students
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jaw relationThe 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. | Procedure or surgery | JIG registration, Wax registration |
| QuestionnaireThe 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. | Procedure or surgery | JIG registration, Wax registration |
Primary outcome
Wax vs JIG Registration
Time frame: 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.
1 secondary outcome
Questionnaire
Time frame: From enrollment to the end of treatment at 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Individual participant dataSharing planned: Undecided. I will share the IPD upon request. All data, study protocol and informed consent of participants can be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Impression Technic, Dental and Jaw Relationship, run by Juliana Marotti Großhausen at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wax vs JIG Registration (time frame: From enrollment to the end of treatment at 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024.