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the purpose of this study is to clarify the rationale for the choice of the upper or lower jaw for positioning the occlusal splint
After being informed about the study and potential risks, all patients are giving written informed consent. Occlusal splints for the upper and lower jaws are made for each of the patients. An assessment is made of the relative values and distribution of chewing forces in two cases:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Occlusal splints | Experimental | In a clinical setting, participants test the closure of the occlusal splint with the antagonistic dentition. Only one of the two occlusal splints (mandibular splint and maxillary splint) is used at a time. Occlusal splints are applied separately and alternately. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Occlusal splint | Device | Occlusal splints are hard, made of polymer biocompatible material using digital additive technology. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference between mandible and maxilla of occlusal splints in terms of stress-strain state and magnitude of displacement of the splinted teeth | By means of the final elemental analysis, data on the stress-strain state (in MPa) and the displacement of the splinted teeth (in mm) will be obtained, individually for each patient. | during one appointment, up to 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between mandible and maxilla dentition in terms of stress-strain state and magnitude of displacement of the teeth | By means of the final elemental analysis, data on the stress-strain state (in MPa) and the displacement of the teeth (in mm) will be obtained, individually for each patient. | during one appointment, up to 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of the influence of the occlusal splint use on the indicators of the stress-strain state and the magnitude of tooth displacement | By means of the final elemental analysis, data on the stress-strain state (in MPa) and the displacement of the teeth (in mm) will be obtained, individually for each patient. | during one appointment, up to 2 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sergey Arutyunov, PhD | A.I. Yevdokimov Moscow State University of Medicine and Dentistry | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A.I. Yevdokimov Moscow State University of Medicine and Dentistry | Moscow | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33918647 | Background | Gribov D, Antonik M, Butkov D, Stepanov A, Antonik P, Kharakh Y, Pivovarov A, Arutyunov S. Personalized Biomechanical Analysis of the Mandible Teeth Behavior in the Treatment of Masticatory Muscles Parafunction. J Funct Biomater. 2021 Apr 9;12(2):23. doi: 10.3390/jfb12020023. |
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Data obtained through this study may be provided to qualified researchers with academic interest in temporomandibular joint disorders.
Data or samples shared will be coded, with no protected health information included.
Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Request will be evaluated under common conditions by Interuniversity Ethics Committee (A.I. Evdokimov Moscow State University of Medicine and Dentistry)
Data requests can be submitted starting 6 months after article publication.
Access to trial IPD (individual participant data) can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
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| ID | Term |
|---|---|
| D007575 | Jaw, Edentulous |
| D009066 | Mouth, Edentulous |
| ID | Term |
|---|---|
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D009057 | Stomatognathic Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| D017090 | Occlusal Splints |
| ID | Term |
|---|---|
| D009989 | Orthotic Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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patients are included in a single study group. In a study group, each patient is assessed for both of the same primary treatment. The final results for each of the treatments for each patient are used for further analysis by the finite element method.
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| D014076 |
| Tooth Diseases |