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

Temporomandibular Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03308266
• Other study ID #: KB-0012/08/15
• Status: Completed
• Phase: N/A
• First received: October 7, 2017
• Last updated: October 7, 2017
• Start date: May 2015
• Est. completion date: June 2016

Study information

• Verified date: October 2017
• Source: Pomeranian Medical University Szczecin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Gender: All
• Age group: 6 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Cleft Lip
• Cleft Lip and Palate
• Disease
• Temporomandibular Disorder
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Diagnostic Test:
• electromyography

Locations

Country	Name	City	State
Poland	Pomeranian Medical University, Department of Orthodontics	Szczecin

Sponsors (1)

Lead Sponsor	Collaborator
Pomeranian Medical University Szczecin

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.