Side Effects of Two Different Mandibular Advancement Devices (MAD) in the Treatment of Snoring and Obstructive Sleep Apnea Syndrome (OSAS)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 65
- Locations
- 9
- Primary Endpoint
- change orofacial pain: numeric rating scale (NRS; 0-10)
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
Unblinded with respect to the examiner, blinded to the patient and statisticians in the evaluation.
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
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
Intervention: H-MAD with a hinge system according to Herbst (Device)
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
Intervention: H-MAD with a hinge system according to Herbst (Device)
Outcomes
Primary Outcomes
change orofacial pain: numeric rating scale (NRS; 0-10)
Time Frame: 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)
Secondary Outcomes
- 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)