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Completed

NCT Number: NCT04050514

Side Effects of Mandibular Advancement Devices

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.

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Key information

Conditions

Obstructive Sleep Apnea Syndrome Apnea Craniomandibular Disorders Dyssomnias Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Sounds Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Snoring Stomatognathic Diseases Temporomandibular Disorders Temporomandibular Joint Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dental Office Dr. Krumholz, Frankfurt, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

H-MAD with a hinge system according to Herbst

Device

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

Primary outcomes

  1. 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

  1. pressure pain points on palpation

    Time frame: 4 weeks, six months, one year, two years

    number of pressure pain points on palpation of the masticatory muscles and in the area of the temporomandibular joints according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)

  2. number of posterior contact points

    Time frame: 4 weeks, six months, one year, two years

    change of the number of occluding posterior teeth

Other outcomes

  1. change in sleep quality: Pittsburgh Sleep Quality Index (PSQI, 0-21, < 5: good sleep)

    Time frame: 4 weeks, six months, one year, two years

    change in sleep quality after applying the MAD measured by Pittsburgh Sleep Quality Index retrospectively asks for a four-week period the incidence of sleep disturbing events, sleep quality assessment, sleep habits, sleep latency and sleep duration, sleeping medication use.

  2. change in daytime sleepiness: Epworth Sleepiness Scale (ESS, 0-24, <11 no daytime sleepiness)

    Time frame: 4 weeks, six months, one year, two years

    Change in daytime sleepiness measured by Epworth Sleepiness Scale. ESS is a short questionnaire for the detection of daytime sleepiness. (ESS, 0-24, <11 no daytime sleepiness)

  3. change in oral health-related quality of life: Oral Health Impact profile (OHIP-5) (0-20)

    Time frame: 4 weeks, six months, one year, two years

    Oral Health Impact profile (OHIP-5) is a measurement tool for assessing the oral health-related quality of life in adults. It consists of 5 questions for functional limitation, physical pain, psychological discomfort, physical disability, social disability

  4. change in chronic pain: Graded Chronic Pain Scale (GCPS) questionnaire (0-4)

    Time frame: 4 weeks, six months, one year, two years

    Graded Chronic Pain Scale (GCPS) questionnaire records pain intensity and the presence of functional or dysfunctional chronic pain. Three subscale scores (characteristic pain intensity, disability score, and the disability points score) are used to classify subjects into 1 of the 5 pain severity grades: grade 0 for no pain, grade 1displays low disability, low intensity, grade 2 displays low disability but high intensity, grade 3 displays high disability,moderately limiting and grade 4 displays high disability and severely limiting.

Sponsors and collaborators

Lead sponsor

University Medicine Greifswald

Other

Registry information

Official study title

Side Effects of Two Different Mandibular Advancement Devices (MAD) in the Treatment of Snoring and Obstructive Sleep Apnea Syndrome (OSAS)

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 8, 2019
Registry last updated
Jun 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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