Side Effects of Mandibular Advancement Devices
Condition: Obstructive Sleep Apnea Syndrome; Temporomandibular Disorders
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome
Study type: Interventional

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.
    

Intervention name(s): H-MAD with a hinge system according to Herbst
Intervention type(s): Device
Intervention description(s): The randomized grouping into blocks at a ratio of 1: 1 takes place over sealed envelopes containing the allocation key for the respective MAD. The assignment is stratified according to gender because gender is a strong predictor of sleep disorders and also temporomandibular dysfunctions Integration of the MAD (start of treatment) The laboratory-made MAD (F-MAD / H-MAD) is integrated and checked for a comfortable fit. The patient is instructed to always wear the splint during sleep.
All patients receive an extended guide to jaw gymnastics with the instruction to do it in the morning after waking up and in the evening before falling asleep.
Four weeks after incorporation, the titration phase begins, the slow adjustment of mandibular advancement to optimize sleep medical parameters while minimizing unwanted side effects.
Control appointments take place after four weeks, six months, one year and two years after insertion of the MAD
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multicenter, randomized two-arm study with active control group, stratified by gender.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: side effects; mandibular advancement device; clinical intervention; snoring; treatment