Acceptance of Mandibular Advancement Devices

Condition(s) studied

Investigational drug(s) / intervention(s)

MAD of the Scheu Dental type with lateral guidance wings (MAD-1): The vertical dimension is raised to achieve an incisal edge distance (IED) of 5 mm using a George Gauge, with a mandibular advancement of 5 mm at insertion, progressing to final titrated advancement during the treatment phase.

MAD of the Panthera X3 type with lateral guidance wings (MAD-2): The vertical dimension is raised to achieve a minimum 2 mm interocclusal cusp distance and the lowest possible IED, with a mandibular advancement of 5 mm at insertion, progressing to final titrated advancement during the treatment phase.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Acceptance of the MAD — 4 weeks, 6 months, 12 months
  wearing comfort of the MAD, assessed using a numeric rating scale (NRS; 0-10) at follow-up time points

Trial sites (1)

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