Masticatory Muscle Activity in Patients With Pain-related Temporomandibular Disorders

• Sponsor: Pomeranian Medical University Szczecin (Other)
• Overall Status: Completed
• CT.gov ID: NCT04409067
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Actual Duration (Months): 2.1
• Patients Per Site Per Month: 43.5

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
TMD	Diagnostic Test: electromyography

Study Design

• Study Type: Observational
• Actual Enrollment: 90 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: The Use of Electromyography in the Assessment of Masticatory Muscle Activity in Patients With Pain-related Temporomandibular Disorders
• Actual Study Start Date: Dec 2, 2019
• Actual Primary Completion Date: Feb 3, 2020
• Actual Study Completion Date: Feb 3, 2020

Arms and Interventions

Arm	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.	Diagnostic Test: 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).
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.	Diagnostic Test: 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).
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.	Diagnostic Test: 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).

Outcome Measures

Primary Outcome Measures

1. Electromyographic analysis of the masticatory muscles in patients with pain-related temporomandibular disorders [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pomeranian Medical University, Department of Orthodontics	Szczecin		Poland

Sponsors and Collaborators

• Pomeranian Medical University Szczecin

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Liliana Szyszka-Sommerfeld, DDS, PhD, Pomeranian Medical University Szczecin
• ClinicalTrials.gov Identifier: NCT04409067
• Other Study ID Numbers: 0012/08/15
• First Posted: Jun 1, 2020
• Last Update Posted: Jun 1, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Liliana Szyszka-Sommerfeld, DDS, PhD, Pomeranian Medical University Szczecin: masticatory muscles; surface electromyography; muscle activity
• Additional relevant MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome

Study Results

No Results Posted as of Jun 1, 2020