Clinical trial NCT05007691: Comparative Study of Maxillary and Mandibular Splints Used for the Treatment of Masticatory Muscle Parafunction (FEA)
Official title: Single-group, Comparative Biomechanical Study of Maxillary and Mandibular Splints Used for the Treatment of Masticatory Muscle Parafunction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Jaw, Edentulous
Mouth, Edentulous
Keywords: Denture, Complete
Technology, Dental
Biomedical and Dental Materials
Lead sponsor: Moscow State University of Medicine and Dentistry
Sponsor class: OTHER
First posted: 2021-08-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: BASIC_SCIENCE

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference between mandible and maxilla of occlusal splints in terms of stress-strain state and magnitude of displacement of the splinted teeth
timeFrame: during one appointment, up to 2 hours
Secondary outcomes:
measure: Difference between mandible and maxilla dentition in terms of stress-strain state and magnitude of displacement of the teeth
timeFrame: during one appointment, up to 2 hours
Other outcomes:
measure: Measurement of the influence of the occlusal splint use on the indicators of the stress-strain state and the magnitude of tooth displacement
timeFrame: during one appointment, up to 2 hours
Locations:
city: Moscow
country: Russian Federation
facility: A.I. Yevdokimov Moscow State University of Medicine and Dentistry
Study officials:
affiliation: A.I. Yevdokimov Moscow State University of Medicine and Dentistry
name: Sergey Arutyunov, PhD
role: STUDY_DIRECTOR
References:
citation: 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.