دورية أكاديمية

Evaluation of the masticatory muscle function, physiological sleep variables, and salivary parameters after electromechanical therapeutic approaches in adult patients with Down syndrome: a randomized controlled clinical trial.

التفاصيل البيبلوغرافية
العنوان: Evaluation of the masticatory muscle function, physiological sleep variables, and salivary parameters after electromechanical therapeutic approaches in adult patients with Down syndrome: a randomized controlled clinical trial.
المؤلفون: Giannasi LC; Center of Biosciences Applied to Patients with Special Health Care Needs (CEBAPE), Institute of Science and Technology, São José dos Campos Campus, São Paulo State University-UNESP, R: Esperança 265, São Paulo, SP, Brazil. odontogiannasi@uol.com.br.; Metropolitan University of Santos, Santos, Brazil. odontogiannasi@uol.com.br.; University Center of Anápolis-UniEvangélica, Anápolis, Brazil. odontogiannasi@uol.com.br., Dutra MTS; Center of Biosciences Applied to Patients with Special Health Care Needs (CEBAPE), Institute of Science and Technology, São José dos Campos Campus, São Paulo State University-UNESP, R: Esperança 265, São Paulo, SP, Brazil., Tenguan VLS; Center of Biosciences Applied to Patients with Special Health Care Needs (CEBAPE), Institute of Science and Technology, São José dos Campos Campus, São Paulo State University-UNESP, R: Esperança 265, São Paulo, SP, Brazil., Mancilha GP; Center of Biosciences Applied to Patients with Special Health Care Needs (CEBAPE), Institute of Science and Technology, São José dos Campos Campus, São Paulo State University-UNESP, R: Esperança 265, São Paulo, SP, Brazil., Silva GRC; Center of Biosciences Applied to Patients with Special Health Care Needs (CEBAPE), Institute of Science and Technology, São José dos Campos Campus, São Paulo State University-UNESP, R: Esperança 265, São Paulo, SP, Brazil., Fillietaz-Bacigalupo E; Center of Biosciences Applied to Patients with Special Health Care Needs (CEBAPE), Institute of Science and Technology, São José dos Campos Campus, São Paulo State University-UNESP, R: Esperança 265, São Paulo, SP, Brazil., da Silva DB; Center of Biosciences Applied to Patients with Special Health Care Needs (CEBAPE), Institute of Science and Technology, São José dos Campos Campus, São Paulo State University-UNESP, R: Esperança 265, São Paulo, SP, Brazil., Politti F; Nove de Julho University, São Paulo, Brazil., Nacif SR; Hospital do Servidor Público Estadual de São Paulo (IAMSPE-HSPE), São Paulo, Brazil., de Oliveira EF; Hospital do Servidor Público Estadual de São Paulo (IAMSPE-HSPE), São Paulo, Brazil., da Rocha JC; Discipline of Pediatric Dentistry Institute of Science and Technology, São Paulo, Brazil., Rocha CT; Center of Biosciences Applied to Patients with Special Health Care Needs (CEBAPE), Institute of Science and Technology, São José dos Campos Campus, São Paulo State University-UNESP, R: Esperança 265, São Paulo, SP, Brazil., Romero MM; Center of Biosciences Applied to Patients with Special Health Care Needs (CEBAPE), Institute of Science and Technology, São José dos Campos Campus, São Paulo State University-UNESP, R: Esperança 265, São Paulo, SP, Brazil., de Oliveira CS; University Center of Anápolis-UniEvangélica, Anápolis, Brazil., de Oliveira LVF; University Center of Anápolis-UniEvangélica, Anápolis, Brazil., de Mello Rode S; Center of Biosciences Applied to Patients with Special Health Care Needs (CEBAPE), Institute of Science and Technology, São José dos Campos Campus, São Paulo State University-UNESP, R: Esperança 265, São Paulo, SP, Brazil., Koga-Ito CY; Center of Biosciences Applied to Patients with Special Health Care Needs (CEBAPE), Institute of Science and Technology, São José dos Campos Campus, São Paulo State University-UNESP, R: Esperança 265, São Paulo, SP, Brazil., Amorim JBO; Center of Biosciences Applied to Patients with Special Health Care Needs (CEBAPE), Institute of Science and Technology, São José dos Campos Campus, São Paulo State University-UNESP, R: Esperança 265, São Paulo, SP, Brazil., Salgado MAC; Center of Biosciences Applied to Patients with Special Health Care Needs (CEBAPE), Institute of Science and Technology, São José dos Campos Campus, São Paulo State University-UNESP, R: Esperança 265, São Paulo, SP, Brazil., Gomes MF; Center of Biosciences Applied to Patients with Special Health Care Needs (CEBAPE), Institute of Science and Technology, São José dos Campos Campus, São Paulo State University-UNESP, R: Esperança 265, São Paulo, SP, Brazil.
المصدر: Trials [Trials] 2019 Apr 11; Vol. 20 (1), pp. 215. Date of Electronic Publication: 2019 Apr 11.
نوع المنشور: Journal Article; Randomized Controlled Trial
اللغة: English
بيانات الدورية: Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials
أسماء مطبوعة: Original Publication: [London] : BioMed Central, 2006-
مواضيع طبية MeSH: Electric Stimulation Therapy*, Down Syndrome/*therapy , Masticatory Muscles/*physiopathology , Saliva/*microbiology , Sleep/*physiology, Adolescent ; Adult ; Down Syndrome/physiopathology ; Electromyography ; Humans ; Hydrocortisone/analysis ; Pseudomonas aeruginosa/isolation & purification ; Saliva/chemistry ; Sample Size ; Young Adult
مستخلص: Background: There are many comorbidities associated with Down syndrome (DS), including obstructive sleep apnea (OSA) and masticatory muscle alteration. Muscular hypotonia, in particular, of the masticatory and oropharyngeal muscles is one of the main characteristics of individuals with DS, resulting in impairments of speech, swallowing, and mastication in these individuals. In addition, total or partial obstruction of the airways during sleep can occur due to pharyngeal hypotonia, leading to snoring and to OSA. This progressive respiratory disorder is associated with a high risk of morbidity and mortality in individuals with DS. The aim of this research is to assess the therapeutic effects of surface neuromuscular electrical stimulation (NMES), the mastication apparatus (MA), and a mandibular advancement oral appliance (OA m ) with an embedded thermosensitive microchip on the functions of masticatory muscles (bilateral masseter and temporal muscles), physiological sleep variables, and salivary parameters in adult patients with DS.
Methods: The patients with DS will be randomly selected and divided into three groups (DS-NMES, DS-MA, and DS-OA m ) with a minimum of 10 patients in each group. A thermosensitive microchip will be embedded in the OA m to record its compliance. The therapeutic effects on masticatory muscle function will be investigated through electromyography, a caliper, and a force-transducer device; the sleep variables, in turn, will be evaluated by means of polysomnography. The physicochemical and microbiological properties of the saliva will also be analyzed, including the salivary flow, viscosity, buffer capacity, cortisol levels (susceptibility to psychological and/or physical stress), and Pseudomonas aeruginosa levels (risk of aspiration pneumonia) in these patients. The methods determined for this study will be carried out prior to and after 2 months of the recommended therapies.
Discussion: The primary outcomes would be the improvement and/or reestablishment of the function of masticatory muscles and the physiological sleep variables in this target public since individuals with DS commonly present generalized muscular hypotonia and dysfunction of the oropharyngeal musculature. As a secondary outcome indicator, the impact of the applied therapies (NMES, MA, and OA m ) on the salivary microbiological and physicochemical properties in DS individuals will also be assessed. Furthermore, the compliance of OA m usage will be measured through a thermosensitive microchip.
Trial Registration: Registro Brasileiro de Ensaios Clínicos, RBR-3qp5np . Registered on 20 February 2018.
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معلومات مُعتمدة: 2017/06835-8 FAPESP
فهرسة مساهمة: Keywords: Cortisol; Down syndrome; Electromyography; Masticatory muscles; Oral appliance; Polysomnography; Saliva; Sleep apnea
المشرفين على المادة: WI4X0X7BPJ (Hydrocortisone)
تواريخ الأحداث: Date Created: 20190413 Date Completed: 20190819 Latest Revision: 20200225
رمز التحديث: 20240628
مُعرف محوري في PubMed: PMC6460660
DOI: 10.1186/s13063-019-3300-0
PMID: 30975204
قاعدة البيانات: MEDLINE
الوصف
تدمد:1745-6215
DOI:10.1186/s13063-019-3300-0