Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2026-03-07 @ 11:47 PM
Study NCT ID:
NCT04409067
Status:
COMPLETED
Last Update Posted:
2020-06-01
First Post:
2020-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Masticatory Muscle Activity in Patients With Pain-related Temporomandibular Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004576', 'term': 'Electromyography'}], 'ancestors': [{'id': 'D004568', 'term': 'Electrodiagnosis'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D009213', 'term': 'Myography'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-02-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-26', 'studyFirstSubmitDate': '2020-05-26', 'studyFirstSubmitQcDate': '2020-05-26', 'lastUpdatePostDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Electromyographic analysis of the masticatory muscles in patients with pain-related temporomandibular disorders', 'timeFrame': 'For a single subject the whole EMG examination was taken 40 minutes.', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['masticatory muscles', 'surface electromyography', 'muscle activity'], 'conditions': ['TMD']}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '7 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The subjects were selected from patients who had been referred to the Orthodontic Clinic in Szczecin, Poland for orthodontic treatment.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* mixed dentition (the subjects should be aged between 7 and 12 years)\n* consent to participate voluntarily in the study\n\nExclusion Criteria:\n\n* 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'}, 'identificationModule': {'nctId': 'NCT04409067', 'briefTitle': 'Masticatory Muscle Activity in Patients With Pain-related Temporomandibular Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Pomeranian Medical University Szczecin'}, 'officialTitle': 'The Use of Electromyography in the Assessment of Masticatory Muscle Activity in Patients With Pain-related Temporomandibular Disorders', 'orgStudyIdInfo': {'id': '0012/08/15'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TMD-pain group', 'description': '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.', 'interventionNames': ['Diagnostic Test: electromyography']}, {'label': 'pain-free TMD group', 'description': '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.', 'interventionNames': ['Diagnostic Test: electromyography']}, {'label': 'non-TMD group', 'description': 'The non-TMD group comprised 30 children aged between 7.2 and 12.5 without any recognised TMD based on RDC/TMD, Axis I.', 'interventionNames': ['Diagnostic Test: electromyography']}], 'interventions': [{'name': 'electromyography', 'type': 'DIAGNOSTIC_TEST', 'description': '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).', 'armGroupLabels': ['TMD-pain group', 'non-TMD group', 'pain-free TMD group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Szczecin', 'country': 'Poland', 'facility': 'Pomeranian Medical University, Department of Orthodontics', 'geoPoint': {'lat': 53.42894, 'lon': 14.55302}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pomeranian Medical University Szczecin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DDS, PhD', 'investigatorFullName': 'Liliana Szyszka-Sommerfeld', 'investigatorAffiliation': 'Pomeranian Medical University Szczecin'}}}}