Comparative Study of Maxillary and Mandibular Splints Used for the Treatment of Masticatory Muscle Parafunction (FEA)
Single-group, Comparative Biomechanical Study of Maxillary and Mandibular Splints Used for the Treatment of Masticatory Muscle Parafunction
1 other identifier
interventional
12
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 16, 2021
CompletedFirst Submitted
Initial submission to the registry
August 10, 2021
CompletedFirst Posted
Study publicly available on registry
August 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 9, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2022
CompletedApril 18, 2022
July 1, 2021
7 months
August 10, 2021
April 15, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Other Outcomes (1)
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
Study Arms (1)
Occlusal splints
EXPERIMENTALIn 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.
Interventions
Occlusal splints are hard, made of polymer biocompatible material using digital additive technology.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- refusal of the patient during the clinical trial from further treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
A.I. Yevdokimov Moscow State University of Medicine and Dentistry
Moscow, Russia
Related 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):23. doi: 10.3390/jfb12020023.
PMID: 33918647BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sergey Arutyunov, PhD
A.I. Yevdokimov Moscow State University of Medicine and Dentistry
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2021
First Posted
August 16, 2021
Study Start
July 16, 2021
Primary Completion
February 9, 2022
Study Completion
May 1, 2022
Last Updated
April 18, 2022
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Data requests can be submitted starting 6 months after article publication.
- Access Criteria
- Access to trial IPD (individual participant data) can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
Data obtained through this study may be provided to qualified researchers with academic interest in temporomandibular joint disorders. Data or samples shared will be coded, with no protected health information included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Request will be evaluated under common conditions by Interuniversity Ethics Committee (A.I. Evdokimov Moscow State University of Medicine and Dentistry)