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Clinical Trials/NCT03308266
NCT03308266
Completed
Not Applicable

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

Pomeranian Medical University Szczecin1 site in 1 country87 target enrollmentMay 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cleft Lip and Palate
Sponsor
Pomeranian Medical University Szczecin
Enrollment
87
Locations
1
Primary Endpoint
Electromyographic analysis of the masticatory muscles in cleft lip and palate children with pain-related temporomandibular disorders
Status
Completed
Last Updated
8 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
May 2015
End Date
June 2016
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Pomeranian Medical University Szczecin
Responsible Party
Principal Investigator
Principal Investigator

Liliana Szyszka-Sommerfeld

DDS, PhD

Pomeranian Medical University Szczecin

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

  • The diagnostic value of electromyography in identifying cleft lip and palate patients with temporomandibular disorders(For a single subject the whole EMG examination was taken 40 minutes.)

Study Sites (1)

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