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光生物调节对唐氏综合征及可能存在睡眠磨牙症儿童的影响:一项随机、对照、盲法临床试验方案:符合SPIRIT标准的临床试验研究方案

Effects of Photobiomodulation in Children with Down Syndrome and Possible Sleep Bruxism: Protocol For A Randomized, Controlled, Blind, Clinical Trial: Study protocol clinical trial (SPIRIT compliant).

作者信息

Salgueiro Mônica da Consolação Canuto, Silva Tamiris, Motta Lara Jansiski, Horliana Anna Carolina Ratto Tempestini, Gonçalves Marcela Letícia Leal, Gomes Andréa Oliver, Pinto Marcelo Mendes, Bortoletto Carolina Carvalho, Altavista Olga Maria, Deana Alessandro Melo, Silva Daniela de Fátima Teixeira da, Santos Elaine Marcilio, Castelo Paula Midori, Fernandes Kristianne Porta Santos, Mesquita-Ferrari Raquel Agnelli, Bussadori Sandra Kalil

机构信息

Universidade Nove de Julho, UNINOVE, São Paulo.

Universidade Metropolitana de Santos, UNIMES, Santos.

出版信息

Medicine (Baltimore). 2020 Apr;99(17):e19904. doi: 10.1097/MD.0000000000019904.

DOI:10.1097/MD.0000000000019904
PMID:32332670
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7440284/
Abstract

Hypotonia, particularly of the masticatory and oropharyngeal muscles, is 1 of the main characteristics of Down Syndrome (DS), resulting in impaired speech, chewing and swallowing. Moreover, the complete or partial obstruction of the airways during sleep may occur due to hypotonia of the tongue, leading to snoring and sleep disorders, such as obstructive apnea and sleep bruxism. OBJECTIVE:: Analyze salivary levels of dopamine and cortisol and muscle activity before and after treatment with low-level laser therapy administered to acupoints in children with DS. METHODS:: A randomized, controlled, clinical trial will be conducted. Individuals 4 to 17 years of age with a diagnosis of DS and possible sleep bruxism will be screened at the Integrated Health Clinic of Nove de Julho University. We will evaluate orofacial dysfunction (Nordic Orofacial Test - Screening questionnaire), Masseter muscle activity during sleep will be assessed by BiteStrip and the masticatory muscles will be evaluated by electromyography (BTS TMJOINT) head posture as well as salivary cortisol and dopamine. After the evaluations, the participants will be randomized into 2 groups: Grupo 1 - treatment with low-level laser therapy at a wavelength of 808 nm; Group 2 - sham treatment (simulated laser therapy). Treatment will be conducted twice per week for a total of 12 sessions. The data will be tabulated and treated using GraphPad Prism version 7.0. The Kolmogorov-Smirnov test will be used to determine the normality of the data. Variables that fit the Gaussian curve will be expressed as mean and standard deviation. The ANOVA 2-way will be used for comparisons between the groups, with the significance level set to 5% (P < .05).ClinicalTrials registration number: NCT04211870.

摘要

肌张力减退,尤其是咀嚼肌和口咽肌的肌张力减退,是唐氏综合征(DS)的主要特征之一,会导致言语、咀嚼和吞咽功能受损。此外,睡眠期间气道可能由于舌肌张力减退而出现完全或部分阻塞,导致打鼾和睡眠障碍,如阻塞性呼吸暂停和睡眠磨牙症。目的:分析低强度激光疗法治疗DS患儿穴位前后唾液中多巴胺和皮质醇水平以及肌肉活动情况。方法:将进行一项随机对照临床试验。在七月九日大学综合健康诊所对4至17岁诊断为DS且可能患有睡眠磨牙症的个体进行筛查。我们将评估口面部功能(北欧口面部测试-筛查问卷),通过BiteStrip评估睡眠期间咬肌活动,通过肌电图(BTS TMJOINT)评估咀嚼肌、头部姿势以及唾液皮质醇和多巴胺。评估后,参与者将被随机分为两组:第1组-采用波长808nm的低强度激光疗法治疗;第2组-假治疗(模拟激光疗法)。治疗每周进行两次,共12次。数据将使用GraphPad Prism 7.0版本进行制表和处理。将使用Kolmogorov-Smirnov检验确定数据的正态性。符合高斯曲线的变量将表示为均值和标准差。将使用双向方差分析进行组间比较,显著性水平设定为5%(P<0.05)。临床试验注册号:NCT04211870。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5234/7440284/5874123fcf52/medi-99-e19904-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5234/7440284/8c026033123d/medi-99-e19904-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5234/7440284/5874123fcf52/medi-99-e19904-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5234/7440284/8c026033123d/medi-99-e19904-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5234/7440284/5874123fcf52/medi-99-e19904-g003.jpg

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