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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-16

Study Completion Date

2022-05-31

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

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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:

1. "maxillary occlusal splint - lower dentition";
2. "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.

Conditions

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Jaw, Edentulous Mouth, Edentulous

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Occlusal splints

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.

Group Type EXPERIMENTAL

Occlusal splint

Intervention Type DEVICE

Occlusal splints are hard, made of polymer biocompatible material using digital additive technology.

Interventions

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Occlusal splint

Occlusal splints are hard, made of polymer biocompatible material using digital additive technology.

Intervention Type DEVICE

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