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

Not Applicable

• Conditions: Mouth, Edentulous; Jaw, Edentulous
• Interventions: Device: Occlusal splint

• Registration Number: NCT05007691
• Lead Sponsor: Moscow State University of Medicine and Dentistry

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.

Study Timeline

• Status Verified: 2021-07
• Study Start: 2021-07-16
• Study First Submitted: 2021-08-10
• Study First Submitted QC: 2021-08-10
• Study First Posted: 2021-08-16
• Primary Completion: 2022-02-09
• Last Update Submitted: 2022-04-15
• Last Update Posted: 2022-04-18
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Occlusal splints	Occlusal splint	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.

Primary Outcome Measures

Name	Time	Method
Difference between mandible and maxilla of occlusal splints in terms of stress-strain state and magnitude of displacement of the splinted teeth	during one appointment, up to 2 hours	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

Name	Time	Method
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	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.

Trial Locations

Locations (1)

A.I. Yevdokimov Moscow State University of Medicine and Dentistry; 🇷🇺 Moscow, Russian Federation