Status:
COMPLETED
Side Effects of Mandibular Advancement Devices
Lead Sponsor:
University Medicine Greifswald
Conditions:
Obstructive Sleep Apnea Syndrome
Temporomandibular Disorders
Eligibility:
All Genders
18-75 years
Phase:
NA
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 pressu...
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 apne...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2022
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT04050514
Start Date
December 1 2019
End Date
December 21 2022
Last Update
June 15 2023
Active Locations (9)
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1
Dental Office Dr. Krumholz
Frankfurt, Germany, 60313
2
Dental Office Dr. Schlieper
Hamburg, Germany, 22607
3
Dental Office Dr. Hauschild
Isernhagen-Süd, Germany, 30916
4
Zahnarztpraxis Weststadt
Karlsruhe, Germany, 76135