Comparative Study of Maxillary and Mandibular Splints Used for the Treatment of Masticatory Muscle Parafunction (FEA)
Primary Purpose
Jaw, Edentulous, Mouth, Edentulous
Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Occlusal splint
Sponsored by
About this trial
This is an interventional basic science trial for Jaw, Edentulous focused on measuring Denture, Complete, Technology, Dental, Biomedical and Dental Materials
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
Sites / Locations
- A.I. Yevdokimov Moscow State University of Medicine and Dentistry
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Occlusal splints
Arm Description
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.
Outcomes
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
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
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.
Full Information
NCT ID
NCT05007691
First Posted
August 10, 2021
Last Updated
April 15, 2022
Sponsor
Moscow State University of Medicine and Dentistry
1. Study Identification
Unique Protocol Identification Number
NCT05007691
Brief Title
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
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 16, 2021 (Actual)
Primary Completion Date
February 9, 2022 (Actual)
Study Completion Date
May 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Moscow State University of Medicine and Dentistry
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaw, Edentulous, Mouth, Edentulous
Keywords
Denture, Complete, Technology, Dental, Biomedical and Dental Materials
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Occlusal splints
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Occlusal splint
Intervention Description
Occlusal splints are hard, made of polymer biocompatible material using digital additive technology.
Primary Outcome Measure Information:
Title
Difference between mandible and maxilla of occlusal splints in terms of stress-strain state and magnitude of displacement of the splinted teeth
Description
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.
Time Frame
during one appointment, up to 2 hours
Secondary Outcome Measure Information:
Title
Difference between mandible and maxilla dentition in terms of stress-strain state and magnitude of displacement of the teeth
Description
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.
Time Frame
during one appointment, up to 2 hours
Other Pre-specified Outcome Measures:
Title
Measurement of the influence of the occlusal splint use on the indicators of the stress-strain state and the magnitude of tooth displacement
Description
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.
Time Frame
during one appointment, up to 2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergey Arutyunov, PhD
Organizational Affiliation
A.I. Yevdokimov Moscow State University of Medicine and Dentistry
Official's Role
Study Director
Facility Information:
Facility Name
A.I. Yevdokimov Moscow State University of Medicine and Dentistry
City
Moscow
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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)
IPD Sharing Time Frame
Data requests can be submitted starting 6 months after article publication.
IPD Sharing 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).
Citations:
PubMed Identifier
33918647
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.
Results Reference
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Comparative Study of Maxillary and Mandibular Splints Used for the Treatment of Masticatory Muscle Parafunction (FEA)
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