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

NCT05007691 — Not applicable, Unknown, 12 participants, Moscow State University of Medicine and Dentistry

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

Registry	NCT05007691
Status	Unknown
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, basic science
Enrollment	12 (Actual)
Sponsor	Moscow State University of Medicine and Dentistry (Other)
Conditions	Jaw, Edentulous, Mouth, Edentulous
Interventions	Occlusal splint (Device)
Dates	start 2021-07-16, primary completion 2022-02-09, completion 2022-05-01 (estimated), first posted 2021-08-16, last updated 2022-04-18
Locations	1 site in Russia

-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

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+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:

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.

+Arms and interventions

Arm	Type	Interventions	Description
Occlusal splints	Experimental	Device: Occlusal splint	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.

Occlusal splint (Device): Occlusal splints are hard, made of polymer biocompatible material using digital additive technology.

+Outcome measures

Primary outcomes

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 outcomes

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 outcomes

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

Sex: All, ages: 18 Years to 50 Years

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

+Locations (1)

Facility	City	Country	Status
A.I. Yevdokimov Moscow State University of Medicine and Dentistry	Moscow	Russia

+Publications

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. PMID 33918647

+Investigators

Sergey Arutyunov, PhD, Study director, A.I. Yevdokimov Moscow State University of Medicine and Dentistry