Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2026-01-24 @ 4:05 AM
Study NCT ID:
NCT03308266
Status:
COMPLETED
Last Update Posted:
2017-10-12
First Post:
2017-10-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electromyographic Analysis of the Masticatory Muscles in Cleft Lip and Palate Children With Temporomandibular Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002971', 'term': 'Cleft Lip'}, {'id': 'D013705', 'term': 'Temporomandibular Joint Disorders'}], 'ancestors': [{'id': 'D008047', 'term': 'Lip Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009056', 'term': 'Mouth Abnormalities'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D017271', 'term': 'Craniomandibular Disorders'}, {'id': 'D008336', 'term': 'Mandibular Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}]}, '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': 87}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-07', 'studyFirstSubmitDate': '2017-10-07', 'studyFirstSubmitQcDate': '2017-10-07', 'lastUpdatePostDateStruct': {'date': '2017-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Electromyographic analysis of the masticatory muscles in cleft lip and palate children 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 temporal and masseter muscles both in the mandibular rest position 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's t test and Mann-Whitney U test to determine differences between the mean values of the independent variables."}], 'secondaryOutcomes': [{'measure': 'The diagnostic value of electromyography in identifying cleft lip and palate patients with 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 temporal and masseter muscles both in the mandibular rest position 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. A mathematical analysis of the ROC curve was used to assess the diagnostic efficiency of electromyography in identifying patients withTMD. The results were described by the area under the curve (AUC), the P value and the ROC coordinate curves, i.e. sensitivity and specificity.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cleft Lip and Palate', 'Temporomandibular Disorder']}, 'referencesModule': {'references': [{'pmid': '30891001', 'type': 'DERIVED', 'citation': 'Szyszka-Sommerfeld L, Machoy M, Lipski M, Wozniak K. The Diagnostic Value of Electromyography in Identifying Patients With Pain-Related Temporomandibular Disorders. Front Neurol. 2019 Mar 5;10:180. doi: 10.3389/fneur.2019.00180. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study was to assess the electrical activity of the temporal and masseter muscles in cleft lip and palate (CLP) children with pain-related temporomandibular disorders (TMD) and in CLP individuals with no TMD by means of surface electromyography (sEMG). Another objective was to determine the diagnostic value of electromyography in identifying CLP patients with temporomandibular disorders. The sample comprised 87 children with CLP and mixed dentition. The children were assessed for the presence of TMD using of the Research Diagnostic Criteria for TMD (RDC/TMD) by a single examiner. A DAB-Bluetooth Instrument (Zebris Medical GmbH, Germany) was used to take electromyographical (EMG) recordings of the temporal and masseter muscles both in the mandibular rest position and during maximum voluntary contraction (MVC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '6 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The subjects were selected from patients who had been referred to three Cleft Care Centres in Szczecin, Poznań and Wrocław, Poland.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* presence of a cleft without a syndrome, a sequence, or karyotype abnormalities\n* presence of mixed dentition\n\nExclusion Criteria:\n\n* the presence of systemic or rheumatologic diseases\n* a history of cervical spine or temporomandibular joint (TMJ) surgery, trauma or malformations'}, 'identificationModule': {'nctId': 'NCT03308266', 'briefTitle': 'Electromyographic Analysis of the Masticatory Muscles in Cleft Lip and Palate Children With Temporomandibular Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Pomeranian Medical University Szczecin'}, 'officialTitle': 'Electromyographic Analysis of the Masticatory Muscles in Cleft Lip and Palate Children With Pain-related Temporomandibular Disorders', 'orgStudyIdInfo': {'id': 'KB-0012/08/15'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CLP children with pain-related TMD', 'interventionNames': ['Diagnostic Test: electromyography']}, {'label': 'CLP children with no TMD', 'interventionNames': ['Diagnostic Test: electromyography']}, {'label': 'CLP children with painfree TMD', 'interventionNames': ['Diagnostic Test: electromyography']}], 'interventions': [{'name': 'electromyography', 'type': 'DIAGNOSTIC_TEST', 'armGroupLabels': ['CLP children with no TMD', 'CLP children with pain-related TMD', 'CLP children with painfree TMD']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Szczecin', 'country': 'Poland', 'facility': 'Pomeranian Medical University, Department of Orthodontics', 'geoPoint': {'lat': 53.42894, 'lon': 14.55302}}]}, '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'}}}}