Shear Wave Sonoelastography in the Diagnosis and Management of the Masseter Muscles Disorders

NCT03844854 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2019-04-04

No results posted yet for this study

Summary

Contemporary medicine lacks sensitive and objective diagnostic methods for the evaluation of patients with temporomandibular disorders (TMD). Shear wave sonoelastography allows for objective assessment of hardness, tone, and cohesiveness of tissues. Results are expressed in kilopascals (kPa) and can be compared at different time points in the same patient or between patients. The method is non-invasive and safe without any unpleasant experiences for patients.

The project aims to evaluate the usefulness of shear wave sonoelastography in the diagnosis and monitoring of the management of masseter muscles disorders in TMD.

The project will analyze shear wave sonoelastography to determine the pathological tone of masticatory muscles in TMD characterized by pain, abnormal jaw movements and frequent coexistence of headache, otolaryngological disorders, as well as increased tension and pain in the muscles of the neck and shoulder girdle. In the first stage, standardization of sonoelastography of masseter muscles on healthy subjects without TMD will be performed. Normal values of elasticity for various groups of patients as well as factors affecting the result of the study will be determined. Standardization will cover the methodology of the examination. The second stage will assess efficacy of this method in monitoring the treatment progress in patients with TMD diagnosed with the DC-TMD protocol. Standardized sonoelastography examinations and assessment of pain and oral health will be conducted in healthy subjects and in TMD patients at baseline and after 12 weeks of treatment with manual therapy and stabilization occlusal splint. As a result, it will be possible to compare sonoelastography changes in muscle structure in relation to regression of clinical symptoms in response to treatment and to compare sonoelastography results to currently used methods for assessment of TMD.

The need for reliable determining of the sonoelastography values for diagnosis of TMD exist. The hardness of muscles of the human body vary, but norms for masticatory muscles remain undetermined. Available reports are inconclusive. They do not provide a methodology and do not address factors such as age, sex, examination at rest and during jaw-clenching. The present project eliminates those limitations, and as a result, contemporary medicine will get the basis for introducing sonoelastography for the diagnosis and monitoring of masticatory muscles disorders in various groups of patients.

Conditions

  • Temporomandibular Disorders

Interventions

OTHER

Stabilization occlusal splint and manual therapy

Providing stabilization occlusal splint and manual therapy

Sponsors & Collaborators

  • National Science Centre, Poland

    collaborator OTHER_GOV
  • Wroclaw Medical University

    lead OTHER

Principal Investigators

  • Mieszko Wieckiewicz, DMD MSc PhD · Department of Experimental Dentistry, Wroclaw Medical University, Poland

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-20
Primary Completion
2019-10-01
Completion
2021-10-01

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Read the full study record

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View NCT03844854 on ClinicalTrials.gov