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Acceptance of Mandibular Advancement Devices

NCT06970171 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-05-06

No results posted yet for this 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.

Conditions

  • Obstructive Sleep Apnea Syndrome (OSAS)

Interventions

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

  • University Medicine Greifswald

    lead OTHER

Principal Investigators

  • Olaf Bernhardt, Prof. Dr. med.dent. · University Medicine Greifswald

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-05
Primary Completion
2027-05-05
Completion
2028-05-01

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06970171 on ClinicalTrials.gov