Obstructive Sleep Apnea Syndrome, Temporomandibular Disorders
Conditions
Keywords
side effects, mandibular advancement device, clinical intervention, snoring, 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.
Interventions
DEVICEH-MAD with a hinge system according to Herbst
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
Sponsors
University Medicine Greifswald
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Unblinded with respect to the examiner, blinded to the patient and statisticians in the evaluation.
Intervention model description
Multicenter, randomized two-arm study with active control group, stratified by gender.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change orofacial pain: numeric rating scale (NRS; 0-10) | 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
| Measure | Time frame | Description |
|---|---|---|
| pressure pain points on palpation | 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) |
| number of posterior contact points | 4 weeks, six months, one year, two years | change of the number of occluding posterior teeth |
Other
| Measure | Time frame | Description |
|---|---|---|
| change in sleep quality: Pittsburgh Sleep Quality Index (PSQI, 0-21, < 5: good sleep) | 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. |
| change in chronic pain: Graded Chronic Pain Scale (GCPS) questionnaire (0-4) | 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. |
| change in daytime sleepiness: Epworth Sleepiness Scale (ESS, 0-24, <11 no daytime sleepiness) | 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) |
| change in oral health-related quality of life: Oral Health Impact profile (OHIP-5) (0-20) | 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 |
Countries
Germany
Outcome results
None listed