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

October 7, 2017 updated by: Liliana Szyszka-Sommerfeld, Pomeranian Medical University Szczecin

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

87

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Szczecin, Poland
        • Pomeranian Medical University, Department of Orthodontics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 13 years (Child)

Accepts Healthy Volunteers

N/A

Genders 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

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

What is the study measuring?

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
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.
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
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.
For a single subject the whole EMG examination was taken 40 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pomeranian Medical University Szczecin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

October 7, 2017

First Submitted That Met QC Criteria

October 7, 2017

First Posted (Actual)

October 12, 2017

Study Record Updates

Last Update Posted (Actual)

October 12, 2017

Last Update Submitted That Met QC Criteria

October 7, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KB-0012/08/15

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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