Status:
NOT_YET_RECRUITING
Acceptance of Mandibular Advancement Devices
Lead Sponsor:
University Medicine Greifswald
Conditions:
Obstructive Sleep Apnea Syndrome (OSAS)
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Background: Obstructive sleep apnea syndrome (OSAS) is a prevalent condition with significant comorbidities. Mandibular advancement devices (MADs) are an established alternative for patients intoleran...
Detailed Description
Partial obstruction of the upper airway during sleep leads to snoring in approximately 40% of men and 24% of women. Epidemiological studies indicate that 50% of these individuals suffer from obstructi...
Eligibility Criteria
Inclusion
- Medical indication for MAD therapy due to OSAS
- Mandibular advancement of at least 5 mm possible
- Fixed prosthetics or stable removable partial dentures
- Bilateral support extending to at least the second premolars
- Legal capacity and signed informed consent
Exclusion
- Polyarthritis
- Mouth opening \< 30 mm
- More than two prior therapy attempts
- Fibromyalgia, neuralgia
- Central sleep apnea syndrome
- Pulmonary diseases
- Untreated generalized periodontitis
- Chronic dysfunctional pain (GCPS Grade 3-4)
- Long-term use of psychotropic or analgesic medications
Key Trial Info
Start Date :
May 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT06970171
Start Date
May 5 2025
End Date
May 1 2028
Last Update
May 14 2025
Active Locations (1)
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1
University Medicine Greifswald, Department of Restorative Dentistry, Periodontology and Endodontology
Greifswald, Mecklenburg-Vorpommern, Germany, 17475