Masticatory Muscle Activity in Patients With Pain-related Temporomandibular Disorders

Completed

• Conditions: TMD
• Interventions: Diagnostic Test: electromyography

• Registration Number: NCT04409067
• Lead Sponsor: Pomeranian Medical University Szczecin

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-02
• Primary Completion: 2020-02-03
• Study Completion: 2020-02-03
• Status Verified: 2020-05
• Study First Submitted: 2020-05-26
• Study First Submitted QC: 2020-05-26
• Last Update Submitted: 2020-05-26
• Study First Posted: 2020-06-01
• Last Update Posted: 2020-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Pomeranian Medical University, Department of Orthodontics; 🇵🇱 Szczecin, Poland