Electromyographic Analysis of the Masticatory Muscles in Cleft Lip and Palate Children With Temporomandibular Disorders
1 other identifier
observational
87
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 7, 2017
CompletedFirst Posted
Study publicly available on registry
October 12, 2017
CompletedOctober 12, 2017
October 1, 2017
1.1 years
October 7, 2017
October 7, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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 Arms (3)
CLP children with pain-related TMD
CLP children with no TMD
CLP children with painfree TMD
Interventions
Eligibility Criteria
The subjects were selected from patients who had been referred to three Cleft Care Centres in Szczecin, Poznań and Wrocław, Poland.
You may qualify if:
- presence of a cleft without a syndrome, a sequence, or karyotype abnormalities
- presence of mixed dentition
You may not qualify if:
- the presence of systemic or rheumatologic diseases
- a history of cervical spine or temporomandibular joint (TMJ) surgery, trauma or malformations
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pomeranian Medical University, Department of Orthodontics
Szczecin, Poland
Related Publications (1)
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.
PMID: 30891001DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- DDS, PhD
Study Record Dates
First Submitted
October 7, 2017
First Posted
October 12, 2017
Study Start
May 1, 2015
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
October 12, 2017
Record last verified: 2017-10