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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05007691
Enrollment
12
Registered
2021-08-16
Start date
2021-07-16
Completion date
2022-05-31
Last updated
2022-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Jaw, Edentulous, Mouth, Edentulous

Keywords

Denture, Complete, Technology, Dental, Biomedical and Dental Materials

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.

Interventions

DEVICEOcclusal splint

Occlusal splints are hard, made of polymer biocompatible material using digital additive technology.

Sponsors

Moscow State University of Medicine and Dentistry
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Difference between mandible and maxilla of occlusal splints in terms of stress-strain state and magnitude of displacement of the splinted teethduring one appointment, up to 2 hoursBy 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

MeasureTime frameDescription
Difference between mandible and maxilla dentition in terms of stress-strain state and magnitude of displacement of the teethduring one appointment, up to 2 hoursBy 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.

Other

MeasureTime frameDescription
Measurement of the influence of the occlusal splint use on the indicators of the stress-strain state and the magnitude of tooth displacementduring one appointment, up to 2 hoursBy 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.

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026