Acceptance of Mandibular Advancement Devices

Enrolling by invitation · Not applicable

Conditions studied: Obstructive Sleep Apnea Syndrome (OSAS)

In brief

Background: Obstructive sleep apnea syndrome (OSAS) is a prevalent condition with significant comorbidities. Mandibular advancement devices (MADs) are an established alternative for patients intolerant to continuous positive airway pressure (CPAP) therapy. However, potential side effects, particularly within the craniomandibular system, warrant further investigation. Objective: This randomized controlled Phase IV trial aims to compare two different MAD designs (UPS-1 by Scheu Dental and UPS-2 by Panthera X3) in terms of patient acceptance, wearing comfort, adherence, and side effects, especially occlusal changes and temporomandibular discomfort, in OSAS patients over a 12-month period. Methods: Twenty-eight patients will be stratified by sex and randomized 1:1 into two treatment groups. Assessments include acceptance of the MAD, clinical and digital occlusal analysis (GEDAS), functional examination (DC/TMD), sleep parameters (AHI, ESS, DI), and patient-reported outcomes. Follow-ups were scheduled at 4 weeks, 6 months, and 12 months post-insertion. Data were collected using standardized CRFs and validated questionnaires. Statistical analysis was based on ordinal regression and intention-to-treat and per-protocol populations. Results \& Conclusion: This study will provide evidence on the comparative efficacy and tolerability of two distinct MAD systems, contributing to improved treatment selection in personalized OSAS management.

Key facts

Study ID

NCT06970171

Run by

University Medicine Greifswald

People needed

28

Starts

2025-05-05

Expected to finish

2028-05-01

Last updated by the study team

2026-05-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University Medicine Greifswald, Department of Restorative Dentistry, Periodontology and Endodontology — Greifswald, Mecklenburg-Vorpommern, Germany

Full record on ClinicalTrials.gov

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