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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 12, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 12, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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