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

Jaw, Edentulous Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05007691
• Other study ID #: Arutyunov-2
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 16, 2021
• Est. completion date: May 2022

Study information

• Verified date: July 2021
• Source: Moscow State University of Medicine and Dentistry
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: May 2022
• Est. primary completion date: February 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Jaw, Edentulous
• Mouth, Edentulous

Intervention

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

Locations

Country	Name	City	State
Russian Federation	A.I. Yevdokimov Moscow State University of Medicine and Dentistry	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Moscow State University of Medicine and Dentistry

Country where clinical trial is conducted

Russian Federation, 

References & Publications (1)

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). pii: 23. doi: 10.3390/jfb12020023. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Measurement of the influence of the occlusal splint use on the indicators of the stress-strain state and the magnitude of tooth displacement	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
Primary	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	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