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临床试验/NCT03308266
NCT03308266已完成不适用

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

Pomeranian Medical University Szczecin1 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
87
试验地点
1
主要终点
Electromyographic analysis of the masticatory muscles in cleft lip and palate children with pain-related temporomandibular disorders

研究概览

简要总结

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).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
6 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • presence of a cleft without a syndrome, a sequence, or karyotype abnormalities
  • presence of mixed dentition

排除标准

  • the presence of systemic or rheumatologic diseases
  • a history of cervical spine or temporomandibular joint (TMJ) surgery, trauma or malformations

结局指标

主要结局

Electromyographic analysis of the masticatory muscles in cleft lip and palate children with pain-related temporomandibular disorders

时间窗: 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.

次要结局

  • 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.)

研究者

发起方
Pomeranian Medical University Szczecin
申办方类型
Other
责任方
Principal Investigator
主要研究者

Liliana Szyszka-Sommerfeld

DDS, PhD

Pomeranian Medical University Szczecin

研究点 (1)

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