Side Effects of Mandibular Advancement Devices
关键词
抽象
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.
This study aims to identify possible side effects in the temporomandibular system that occur during the course of two years of nocturnal MAD delivery. Two different appliance systems are compared in terms of construction height (bite elevation) and protrusion mechanics: the H-MAD ™ with a hinge system according to Herbst and the SomnoDent Fusion ™ (called F-MAD) with sliding side wings.
日期
| 最后验证: | 05/31/2020 |
| 首次提交: | 07/31/2019 |
| 提交的预估入学人数: | 08/05/2019 |
| 首次发布: | 08/07/2019 |
| 上次提交的更新: | 06/14/2020 |
| 最近更新发布: | 06/15/2020 |
| 实际学习开始日期: | 11/30/2019 |
| 预计主要完成日期: | 11/30/2022 |
| 预计完成日期: | 12/20/2022 |
状况或疾病
干预/治疗
Device: H-MAD with a hinge system according to Herbst
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: H-MAD, hinge system according to Herbst 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 | |
| Active Comparator: F-MAD, SomnoDent Fusion 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 |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - 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 Exclusion Criteria: - 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) |
结果
主要结果指标
1. change orofacial pain: numeric rating scale (NRS; 0-10) [4 weeks, six months, one year, two years]
次要成果指标
1. pressure pain points on palpation [4 weeks, six months, one year, two years]
2. number of posterior contact points [4 weeks, six months, one year, two years]
其他成果措施
1. change in sleep quality: Pittsburgh Sleep Quality Index (PSQI, 0-21, < 5: good sleep) [4 weeks, six months, one year, two years]
2. change in daytime sleepiness: Epworth Sleepiness Scale (ESS, 0-24, <11 no daytime sleepiness) [4 weeks, six months, one year, two years]
3. change in oral health-related quality of life: Oral Health Impact profile (OHIP-5) (0-20) [4 weeks, six months, one year, two years]
4. change in chronic pain: Graded Chronic Pain Scale (GCPS) questionnaire (0-4) [4 weeks, six months, one year, two years]
