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

the purpose of this study is to clarify the rationale for the choice of the upper or lower jaw for positioning the occlusal splint

Study Overview

• Status: Active, not recruiting
• Conditions: Mouth, Edentulous; Jaw, Edentulous
• Intervention / Treatment: Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation
    • A.I. Yevdokimov Moscow State University of Medicine and Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Occlusal splints; 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.	Device: Occlusal splint; Occlusal splints are hard, made of polymer biocompatible material using digital additive technology.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Moscow State University of Medicine and Dentistry
• Investigators: Study Director: Sergey Arutyunov, PhD, A.I. Yevdokimov Moscow State University of Medicine and Dentistry

Publications and helpful links

General 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). pii: 23. doi: 10.3390/jfb12020023.

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2021
• Primary Completion (Actual): February 9, 2022
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: August 10, 2021
• First Submitted That Met QC Criteria: August 10, 2021
• First Posted (Actual): August 16, 2021

Study Record Updates

• Last Update Posted (Actual): April 18, 2022
• Last Update Submitted That Met QC Criteria: April 15, 2022
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Denture, Complete; Technology, Dental; Biomedical and Dental Materials
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Jaw Diseases; Mouth, Edentulous; Jaw, Edentulous; Anti-Infective Agents; Dermatologic Agents; Antifungal Agents; Keratolytic Agents; Salicylic Acid
• Other Study ID Numbers: Arutyunov-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD 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).
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No