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临床试验/NCT04211870
NCT04211870已完成1 期

Effects of Photobiomodulation in Children With Down Syndrome and Possible Sleep Bruxism: Protocol For A Randomized, Controlled, Blind, Clinical Trial

University of Nove de Julho2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2022年3月20日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
19
试验地点
2
主要终点
Evaluation of electromyography of masticatory muscles

研究概览

简要总结

The main characteristic of an individual with Trisomy 21 (T21), commonly known as Down Syndrome (DS), is muscular hypotonia, a characteristic that mainly affects the masticatory and oropharyngeal muscles, resulting in impairments in speech, swallowing, breathing and chewing, in addition to pain, noise and/or degeneration in the temporomandibular joints (TMJ), therefore, developing bruxism. The gold standard for the treatment and control of bruxism is the rigid plate, however, there is difficulty in developing treatment in children and adolescents with T21, therefore, photobiomodulation is a non-invasive intervention alternative already consolidated as an excellent option for modulation in muscle tissues. This study sought to evaluate the efficacy and safety of non-invasive intervention with red LED clusters for the control of bruxism in children and adolescents diagnosed with Down Syndrome. The present study is characterized as a pilot study, composed of individuals of both sexes, aged 4 to 17 years old, attended at the UNINOVE integrated health clinic and diagnosed with Down syndrome and bruxism. The treatment was carried out in a total of four sessions, one session per week, where in each session the LED plates were applied and post-application electromyographic collection was carried out.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None (Participant)

入排标准

年龄范围
4 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children and adolescents with a diagnosis of Down syndrome
  • Four to 17 years of age
  • Bruxism, based on parental reports of the occurrence of grinding the teeth, incisal and/or occlusal tooth wear following the criteria of the American Academy of Sleep Medicine (AASM) and the questionnaire for the evaluation of bruxism validated by Serra Negra et al. (2014) and a systematic review performed by Manfredini et al. (2013).

排除标准

  • Use of muscle relaxant
  • Temporomandibular disorder
  • Undergoing other therapy for bruxism
  • Other associated neurological diseases
  • Cognitive deficit that impedes understanding the evaluations.

结局指标

主要结局

Evaluation of electromyography of masticatory muscles

时间窗: Baseline and immediately after each the procedure.

The activation of the masseter muscles (right and left) and anterior temporalis (right and left) has analyses of electrical activities that were collected by means of the BTS TMJOINT electromyograph from BTS Engineering with 6 channels, 4 of which are used, containing a bioelectric signal amplifier, wireless data transmission (wireless system) and disposable bipolar surface electrodes (Ag/AgCl - Medical Trace®) with 10 mm in diameter. The EMG signal was amplified with a gain of 2000 times and filtered within a frequency of 20-450 Hz. The impedance and common rejection mode of the equipment are \>1015 Ω//0.2 pF and 60/10Hz 92 dB.

次要结局

  • Orofacial Evaluation Through NOT-S (score from 0 to 12)(Baseline and immediately after each the procedure.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sandra Kalil Bussadori

Principal Investigator

University of Nove de Julho

研究点 (2)

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