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

NCT ID: NCT03308266

Last Updated: 2017-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

87 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-06-30

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).

Detailed Description

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Conditions

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Cleft Lip and Palate Temporomandibular Disorder

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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CLP children with pain-related TMD

electromyography

Intervention Type DIAGNOSTIC_TEST

CLP children with no TMD

electromyography

Intervention Type DIAGNOSTIC_TEST

CLP children with painfree TMD

electromyography

Intervention Type DIAGNOSTIC_TEST

Interventions

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electromyography

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

6 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pomeranian Medical University Szczecin

OTHER

Sponsor Role lead

Responsible Party

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Liliana Szyszka-Sommerfeld

DDS, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pomeranian Medical University, Department of Orthodontics

Szczecin, , Poland

Site Status

Countries

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Poland

References

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Szyszka-Sommerfeld L, Machoy M, Lipski M, Wozniak K. The Diagnostic Value of Electromyography in Identifying Patients With Pain-Related Temporomandibular Disorders. Front Neurol. 2019 Mar 5;10:180. doi: 10.3389/fneur.2019.00180. eCollection 2019.

Reference Type DERIVED
PMID: 30891001 (View on PubMed)

Other Identifiers

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KB-0012/08/15

Identifier Type: -

Identifier Source: org_study_id