Clinical trial NCT04050514: Side Effects of Mandibular Advancement Devices
Official title: Side Effects of Two Different Mandibular Advancement Devices (MAD) in the Treatment of Snoring and Obstructive Sleep Apnea Syndrome (OSAS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea Syndrome
Temporomandibular Disorders
Keywords: side effects
mandibular advancement device
clinical intervention
snoring
treatment
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2019-08-08
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, randomized two-arm study with active control group, stratified by gender.
Primary purpose: TREATMENT

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.

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.

Eligibility 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)

Primary outcomes:
measure: change orofacial pain: numeric rating scale (NRS; 0-10)
timeFrame: 4 weeks, six months, one year, two years
Secondary outcomes:
measure: pressure pain points on palpation
timeFrame: 4 weeks, six months, one year, two years
measure: number of posterior contact points
timeFrame: 4 weeks, six months, one year, two years
Other outcomes:
measure: change in sleep quality: Pittsburgh Sleep Quality Index (PSQI, 0-21, < 5: good sleep)
timeFrame: 4 weeks, six months, one year, two years
measure: change in daytime sleepiness: Epworth Sleepiness Scale (ESS, 0-24, <11 no daytime sleepiness)
timeFrame: 4 weeks, six months, one year, two years
measure: change in oral health-related quality of life: Oral Health Impact profile (OHIP-5) (0-20)
timeFrame: 4 weeks, six months, one year, two years
measure: change in chronic pain: Graded Chronic Pain Scale (GCPS) questionnaire (0-4)
timeFrame: 4 weeks, six months, one year, two years
Locations:
city: Frankfurt
country: Germany
facility: Dental Office Dr. Krumholz
city: Hamburg
country: Germany
facility: Dental Office Dr. Schlieper
city: Isernhagen
country: Germany
facility: Dental Office Dr. Hauschild
city: Karlsruhe
country: Germany
facility: Zahnarztpraxis Weststadt
city: Saarbrücken
country: Germany
facility: Dental Office Dr. Kares
city: Saarlouis
country: Germany
facility: Dental Office Dr. Heckmann
city: Solingen
country: Germany
facility: Dental Office Dr. Meyer
city: Sulzbach
country: Germany
facility: Dental Office Dr. Nauert
city: Würzburg
country: Germany
facility: Mund-Zahn-Kiefer-Klinik
Study officials:
affiliation: University Medicine Greifswald
name: Olaf Bernhardt, Prof.
role: PRINCIPAL_INVESTIGATOR
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