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

Study Overview
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Brief Summary
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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).

Official Title
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Electromyographic Analysis of the Masticatory Muscles in Cleft Lip and Palate Children With Pain-related Temporomandibular Disorders

Conditions
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Cleft Lip and Palate, Temporomandibular Disorder

Intervention / Treatment
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* Diagnostic Test: electromyography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CLP children with pain-related TMD<br> | Diagnostic Test: electromyography<br> <br> |
| CLP children with no TMD<br> | Diagnostic Test: electromyography<br> <br> |
| CLP children with painfree TMD<br> | Diagnostic Test: electromyography<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electromyographic analysis of the masticatory muscles in cleft lip and palate children with pain-related temporomandibular disorders | 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. | For a single subject the whole EMG examination was taken 40 minutes. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The diagnostic value of electromyography in identifying cleft lip and palate patients with temporomandibular disorders | 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. | For a single subject the whole EMG examination was taken 40 minutes. |