Masticatory Muscle Activity in Patients With Pain-related Temporomandibular Disorders

NCT ID: NCT04409067

Last Updated: 2020-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-02

Study Completion Date

2020-02-03

Brief Summary

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The aim of this study was to evaluate masticatory muscle electrical activity in patients with pain-related and pain-free temporomandibular disorders (TMD) as well as in subjects with no TMD. Ninety children with mixed dentition were recruited to the study. Of this total, 30 subjects were diagnosed with pain-related TMD, 30 with pain-free TMD, and 30 without TMD. We used Axis I of the Research Diagnostic Criteria for TMD (RDC/TMD) to assess the presence of TMD in the examined children. The electromyographical (EMG) potentials of the temporalis and masseter muscles were measured with a DAB-Bluetooth Instrument (Zebris Medical GmbH, Germany) at rest and during maximum voluntary clenching (MVC).

Detailed Description

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Conditions

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TMD

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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TMD-pain group

The TMD-pain group consisted of 30 children aged between 7.1 and 12.3 with a pain-related TMD diagnosis. All the patients in the TMD-pain group had myogenous or arthrogenous TMD according to the RDC/TMD protocol.

electromyography

Intervention Type DIAGNOSTIC_TEST

Surface electromyography (sEMG) was used as an additional non-invasive tool for assessing patients with TMD.The electromyographical (EMG) potentials of the temporalis and masseter muscles were measured with a DAB-Bluetooth Instrument (Zebris Medical GmbH, Germany) at rest and during maximum voluntary clenching (MVC).

pain-free TMD group

The pain-free TMD group consisted of 30 children between 7.3 and 12.6 years of age. To be included in the pain-free TMD group the participants had to meet Axis I of the RDC/TMD criteria for a pain-free diagnosis.

electromyography

Intervention Type DIAGNOSTIC_TEST

Surface electromyography (sEMG) was used as an additional non-invasive tool for assessing patients with TMD.The electromyographical (EMG) potentials of the temporalis and masseter muscles were measured with a DAB-Bluetooth Instrument (Zebris Medical GmbH, Germany) at rest and during maximum voluntary clenching (MVC).

non-TMD group

The non-TMD group comprised 30 children aged between 7.2 and 12.5 without any recognised TMD based on RDC/TMD, Axis I.

electromyography

Intervention Type DIAGNOSTIC_TEST

Surface electromyography (sEMG) was used as an additional non-invasive tool for assessing patients with TMD.The electromyographical (EMG) potentials of the temporalis and masseter muscles were measured with a DAB-Bluetooth Instrument (Zebris Medical GmbH, Germany) at rest and during maximum voluntary clenching (MVC).

Interventions

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electromyography

Surface electromyography (sEMG) was used as an additional non-invasive tool for assessing patients with TMD.The electromyographical (EMG) potentials of the temporalis and masseter muscles were measured with a DAB-Bluetooth Instrument (Zebris Medical GmbH, Germany) at rest and during maximum voluntary clenching (MVC).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* mixed dentition (the subjects should be aged between 7 and 12 years)
* consent to participate voluntarily in the study

Exclusion Criteria

* subjects who had undergone orthodontic or masticatory motor system dysfunction treatment, had systemic or rheumatologic diseases, a history of mouth breathing, surgery, traumas or malformations in the head and neck region
Minimum Eligible Age

7 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pomeranian Medical University Szczecin

OTHER

Sponsor Role lead

Responsible Party

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Liliana Szyszka-Sommerfeld

DDS, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pomeranian Medical University, Department of Orthodontics

Szczecin, , Poland

Site Status

Countries

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Poland

Other Identifiers

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0012/08/15

Identifier Type: -

Identifier Source: org_study_id

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