Side Effects of Mandibular Advancement Devices
Keywords
Abstract
Description
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.
Dates
| Last Verified: | 05/31/2020 |
| First Submitted: | 07/31/2019 |
| Estimated Enrollment Submitted: | 08/05/2019 |
| First Posted: | 08/07/2019 |
| Last Update Submitted: | 06/14/2020 |
| Last Update Posted: | 06/15/2020 |
| Actual Study Start Date: | 11/30/2019 |
| Estimated Primary Completion Date: | 11/30/2022 |
| Estimated Study Completion Date: | 12/20/2022 |
Condition or disease
Intervention/treatment
Device: H-MAD with a hinge system according to Herbst
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| 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 |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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) |
Outcome
Primary Outcome Measures
1. change orofacial pain: numeric rating scale (NRS; 0-10) [4 weeks, six months, one year, two years]
Secondary Outcome Measures
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]
Other Outcome Measures
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]
