Masticatory Muscle Activity in Patients With Pain-related Temporomandibular Disorders

May 26, 2020 updated by: Liliana Szyszka-Sommerfeld, Pomeranian Medical University Szczecin

The Use of Electromyography in the Assessment of Masticatory Muscle Activity in Patients With Pain-related Temporomandibular Disorders

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Szczecin, Poland
        • Pomeranian Medical University, Department of Orthodontics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 12 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The subjects were selected from patients who had been referred to the Orthodontic Clinic in Szczecin, Poland for orthodontic treatment.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.
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.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electromyographic analysis of the masticatory muscles in patients with pain-related temporomandibular disorders
Time Frame: For a single subject the whole EMG examination was taken 40 minutes.
A DAB-Bluetooth Instrument (Zebris Medical GmbH, Germany) was used to take electromyographical (EMG) recordings of the temporalis and masseter muscles at rest and during maximum voluntary contraction (MVC).Disposable, self-adhesive Ag/AgCl bipolar surface electrodes were placed at a fixed inter-electrode distance of 20 mm on the anterior temporal muscles and on the superficial masseter muscles parallel to the muscular fibres. The EMG signals were amplified, digitized and digitally filtered. The EMG results were analysed using the Student t-test, analysis of variance (ANOVA) and a Student-Newman-Keuls post-hoc test.
For a single subject the whole EMG examination was taken 40 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 2, 2019

Primary Completion (ACTUAL)

February 3, 2020

Study Completion (ACTUAL)

February 3, 2020

Study Registration Dates

First Submitted

May 26, 2020

First Submitted That Met QC Criteria

May 26, 2020

First Posted (ACTUAL)

June 1, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 1, 2020

Last Update Submitted That Met QC Criteria

May 26, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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