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

M

Moscow State University of Medicine and Dentistry

Status

Unknown

Conditions

Mouth, Edentulous
Jaw, Edentulous

Treatments

Device: Occlusal splint

Study type

Interventional

Funder types

Other

Identifiers

NCT05007691
Arutyunov-2

Details and patient eligibility

About

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

Full 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.

Enrollment

12 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

12 participants in 1 patient group

Occlusal splints
Experimental group
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.
Treatment:
Device: Occlusal splint

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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