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临床试验/NCT04050514
NCT04050514已完成不适用

Side Effects of Two Different Mandibular Advancement Devices (MAD) in the Treatment of Snoring and Obstructive Sleep Apnea Syndrome (OSAS)

University Medicine Greifswald9 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2019年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
65
试验地点
9
主要终点
change orofacial pain: numeric rating scale (NRS; 0-10)

研究概览

简要总结

Sleep-related breathing disorders (SBAS) are one of the most common causes of non-restorative sleep.

Sleep therapy options include positive pressure ventilation with continuous positive airway pressure (CPAP) masks, mandibular advancement of the mandible with mandibular advancement devices (MAD), back restraining, weight reduction, ear, nose and throat surgical procedures, bimaxillary or mandibular remodeling osteotomies, and neurostimulation procedures N. hypoglossal. In mild to moderate obstructive sleep apnea syndrome (OSAS), MAD, back suppression and weight reduction are potential treatment options. This study aims to identify possible side effects in the temporomandibular system that occur during nocturnal support of a mandibular arch over two years. Two different MADs are compared in terms of construction, height (bite elevation) and protrusion mechanics: the H-MAD with an hinge system according to Herbst and the SomnoDent Fusion ™ MAD (called F-MAD) with sliding side wings.

In addition, it is to be evaluated whether hinge system according to Herbst as a protrusion-controlling element and the reduction of the splint body for a reduced bite elevation leads to a significant reduction of side effects compared to the F-MAD.

详细描述

Sleep-related breathing disorders (SBAS), particularly obstructive sleep apnea syndrome (OSAS), are one of the most common causes of non-restorative sleep. Disturbances of sleep disorders include apneas and hypopneas associated with either or not pharyngeal obstruction and hypoventilation. Depending on the type of respiratory disorder present, they are associated with hypoxemia and may cause hypercapnia or acidosis The consequences of obstructive narrowing of the pharynx are far-reaching. Studies have shown that patients with OSAS have comorbidities such as neurological complaints, heart attacks, dementia, cardiovascular complaints, myocardial infarction, and a higher mortality rate.

Sleep fragmentation caused by respiratory disorders during sleep and wakefulness reactions (arousals) can lead to daytime sleepiness and concentration disorders. In the longer term untreated arousals and apneas are associated with an increased risk for arterial hypertension, stroke, myocardial infarction, diabetes mellitus and libido loss.

OSAS management includes positive pressure ventilation with continuous positive airway pressure (CPAP) masks, mandibular advancement of the mandible with mandibular advancement devices (MAD), weight loss, ear, nose and throat surgical procedures, bimaxillary or mandibular remodeling osteotomies, and neurostimulation procedures of the hypoglossal nerve.

Several studies have shown that the use of MADs is inferior in reducing the severity of OSAS in comparison to CPAP therapy, but its efficacy is comparable and preferred by patients in mild to moderate OSAS.

Due to the forward displacement of the lower jaw for several hours at night, similar symptoms as in temporomandibular dysfunction (TMD) patients may occur. The symptoms may be pain or stiffness on the masticatory muscles or temporomandibular joints.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Unblinded with respect to the examiner, blinded to the patient and statisticians in the evaluation.

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with medical indication for mandibular protrusion (MAD) due to OSAS
  • •therapy request for snoring
  • •Body Mass Index (BMI) ≤ 35
  • •mandibular protrusion of 5 mm possible
  • •at least 8 remaining teeth or 4 implants per jaw
  • •fixed dentures and stable
  • •removable partial denture, at least support up to the area of the 2nd premolars on both sides
  • •business ability and the existence of the signed declaration of consent

排除标准

  • •polyarthritis
  • •fibromyalgia, neuralgia
  • •central sleep apnea syndrome
  • •untreated generalized periodontitis
  • •chronic dysfunctional pain degree 3-4
  • •long-term use of psychotropics and analgesics (> 4 weeks)
  • •pregnancy
  • •participation in another interventional clinical study (currently up to three months before inclusion)

研究组 & 干预措施

H-MAD, hinge system according to Herbst

Experimental

Patients with snoring and OSAS. Therapy with MAD type H-MAD with lateral hinges according to Herbst.

Bite elevation 2 mm interocclusal distance with a lower jaw advancement of 5 mm

干预措施: H-MAD with a hinge system according to Herbst (Device)

F-MAD, SomnoDent Fusion

Active Comparator

Patients with snoring and OSAS,Fusion MAD with sliding side wings (F-MAD). Bite elevation 5 mm interocclusal distance with a lower jaw advancement of 5 mm

干预措施: H-MAD with a hinge system according to Herbst (Device)

结局指标

主要结局

change orofacial pain: numeric rating scale (NRS; 0-10)

时间窗: 4 weeks, six months, one year, two years

change of orofacial pain after applying the MAD measured by numeric rating scale (NRS; 0-10, 0: no pain, 10: worst imaginable pain)

次要结局

  • pressure pain points on palpation(4 weeks, six months, one year, two years)
  • number of posterior contact points(4 weeks, six months, one year, two years)

研究者

发起方
University Medicine Greifswald
申办方类型
Other
责任方
Sponsor

研究点 (9)

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