Acceptance of Mandibular Advancement Devices
Key facts
- Who runs it
- University Medicine Greifswald
- Where
- Germany1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Enrolling by invitation
- People taking part
- 28 people, planned
- Started
- 5 May 2025
- Expected to end
- 1 May 2028
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- MAD of the Scheu Dental type with lateral guidance wings (MAD-1)
- MAD of the Panthera X3 type with lateral guidance wings (MAD-2)
- Record updated
- 6 May 2026
Who can take part
- Age
- 18 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Who cannot take part
- More than two prior therapy attempts
- Long-term use of psychotropic or analgesic medications
- Central sleep apnea syndrome
- Pulmonary diseases
- Polyarthritis
- Mouth opening < 30 mm
- Fibromyalgia, neuralgia
- Untreated generalized periodontitis
- Chronic dysfunctional pain (GCPS Grade 3-4)
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Patients randomly selected for arm 1 MAD treatmentTreatment being tested
Patients with primary snoring or with a medical indication for MAD therapy due to OSAS. Patients age must be ≥ 18 and ≤ 75 years. Patients must have a mandibular advancement of at least 5 mm possible (titration starts at 5 mm). Patients must have at least 8 teeth or 4 implants per jaw or with fixed prosthetics or stable removable partial dentures, bilateral support extending to at least the second premolars.
Treatment: MAD of the Scheu Dental type with lateral guidance wings (MAD-1)
- Patients randomly assigned to arm 2 MAD treatment.Existing treatment, for comparison
Patients with primary snoring or with a medical indication for MAD therapy due to OSAS. Patients age must be ≥ 18 and ≤ 75 years. Patients must have a mandibular advancement of at least 5 mm possible (titration starts at 5 mm). Patients must have at least 8 teeth or 4 implants per jaw or with fixed prosthetics or stable removable partial dentures, bilateral support extending to at least the second premolars.
Treatment: MAD of the Panthera X3 type with lateral guidance wings (MAD-2)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Acceptance and Side Effects of Two Different Mandibular Advancement Devices (MADs) in the Treatment of Obstructive Sleep Apnea Syndrome (OSAS)
- Fit questions
- Built from NCT06970171, who can take part
- Record updated
- 6 May 2026