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

Sponsor

Moscow State University of Medicine and Dentistry (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05007691

Collaborator

(none)

Enrollment

Location

Arm

9.5

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

the purpose of this study is to clarify the rationale for the choice of the upper or lower jaw for positioning the occlusal splint

Condition or Disease	Intervention/Treatment	Phase
Jaw, Edentulous Mouth, Edentulous	Device: Occlusal splint	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention 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.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)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Jul 16, 2021

Actual Primary Completion Date :

Feb 9, 2022

Anticipated Study Completion Date :

May 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: Occlusal splint Occlusal splints are hard, made of polymer biocompatible material using digital additive technology.

Arm

Intervention/Treatment

Experimental: 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.

Device: Occlusal splint

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

Outcome Measures

Primary Outcome Measures

Difference between mandible and maxilla of occlusal splints in terms of stress-strain state and magnitude of displacement of the splinted teeth [during one appointment, up to 2 hours]
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.

Secondary Outcome Measures

Difference between mandible and maxilla dentition in terms of stress-strain state and magnitude of displacement of the teeth [during one appointment, up to 2 hours]
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.

Other Outcome Measures

Measurement of the influence of the occlusal splint use on the indicators of the stress-strain state and the magnitude of tooth displacement [during one appointment, up to 2 hours]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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