Comparative Study of Maxillary and Mandibular Splints Used for the Treatment of Masticatory Muscle Parafunction (FEA)

Study Overview
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Brief Summary
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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

Detailed Description
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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: maxillary occlusal splint - lower dentition; mandibular occlusal splint - upper dentition. The obtained values are used in the final elemental analysis of the stress-strain state and the degree of displacement of the dentition in both indicated cases.

Official Title
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Single-group, Comparative Biomechanical Study of Maxillary and Mandibular Splints Used for the Treatment of Masticatory Muscle Parafunction

Conditions
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Jaw, Edentulous, Mouth, Edentulous

Intervention / Treatment
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* Device: Occlusal splint


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: continuous dentition diagnosis (by ICD*-10): K03.0 Excessive attrition of teeth diagnosis (by ICD-10): K07.6 Temporomandibular joint disorders complaints of nocturnal bruxism complaints of discomfort in the area of the chewing muscles no history of orthopedic and / or orthodontic treatment absence of concomitant general somatic pathologies in the stage of decompensation no history of psychogenic and psychosomatic disorders no history of cancer *ICD - Classification of Diseases Exclusion Criteria: refusal of the patient during the clinical trial from further treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Occlusal splints<br>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. | Device: Occlusal splint<br>* Occlusal splints are hard, made of polymer biocompatible material using digital additive technology.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Denture, Complete, Technology, Dental, Biomedical and Dental Materials