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Electromyographic Analysis of the Masticatory Muscles in Cleft Lip and Palate Children With Temporomandibular Disorders

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ClinicalTrials.gov Identifier: NCT03308266
Recruitment Status : Completed
First Posted : October 12, 2017
Last Update Posted : October 12, 2017
Sponsor:
Information provided by (Responsible Party):
Liliana Szyszka-Sommerfeld, Pomeranian Medical University Szczecin

Brief Summary:
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).

Condition or disease Intervention/treatment
Cleft Lip and Palate Temporomandibular Disorder Diagnostic Test: electromyography

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Study Type : Observational
Actual Enrollment : 87 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Electromyographic Analysis of the Masticatory Muscles in Cleft Lip and Palate Children With Pain-related Temporomandibular Disorders
Actual Study Start Date : May 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
CLP children with pain-related TMD Diagnostic Test: electromyography
CLP children with no TMD Diagnostic Test: electromyography
CLP children with painfree TMD Diagnostic Test: electromyography



Primary Outcome Measures :
  1. Electromyographic analysis of the masticatory muscles in cleft lip and palate children 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 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.


Secondary Outcome Measures :
  1. The diagnostic value of electromyography in identifying cleft lip and palate patients with 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 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.



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Ages Eligible for Study:   6 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
The subjects were selected from patients who had been referred to three Cleft Care Centres in Szczecin, Poznań and Wrocław, Poland.
Criteria

Inclusion Criteria:

  • presence of a cleft without a syndrome, a sequence, or karyotype abnormalities
  • presence of mixed dentition

Exclusion Criteria:

  • the presence of systemic or rheumatologic diseases
  • a history of cervical spine or temporomandibular joint (TMJ) surgery, trauma or malformations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03308266


Locations
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Poland
Pomeranian Medical University, Department of Orthodontics
Szczecin, Poland
Sponsors and Collaborators
Pomeranian Medical University Szczecin
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Liliana Szyszka-Sommerfeld, DDS, PhD, Pomeranian Medical University Szczecin
ClinicalTrials.gov Identifier: NCT03308266    
Other Study ID Numbers: KB-0012/08/15
First Posted: October 12, 2017    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Cleft Lip
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Musculoskeletal Diseases
Joint Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes
Lip Diseases
Mouth Diseases
Mouth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities