NCT04050514

Side Effects of Mandibular Advancement Devices

Completed NA Last updated 15 June 2023

What this trial tests

NA trial testing H-MAD with a hinge system according to Herbst in Obstructive Sleep Apnea Syndrome in 65 participants. Completed in 21 December 2022.

Timeline

1 December 2019

Primary endpoint
1 December 2022

21 December 2022

Quick facts

Lead sponsor	University Medicine Greifswald
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	65
Start date	1 December 2019
Primary completion	1 December 2022
Estimated completion	21 December 2022
Sites	9 locations across Germany

Drugs / interventions tested

• H-MAD with a hinge system according to Herbst

Conditions studied

• Obstructive Sleep Apnea Syndrome — all drugs for Obstructive Sleep Apnea Syndrome →
• Temporomandibular Disorders — all drugs for Temporomandibular Disorders →

Sponsor

University Medicine Greifswald

Who can join

Adults 18 to 75, any sex, with Obstructive Sleep Apnea Syndrome or Temporomandibular Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Sleep-related breathing disorders (SBAS) are one of the most common causes of non-restorative sleep.

Sleep therapy options include positive pressure ventilation with continuous positive airway pressure (CPAP) masks, mandibular advancement of the mandible with mandibular advancement devices (MAD), back restraining, weight reduction, ear, nose and throat surgical procedures, bimaxillary or mandibular remodeling osteotomies, and neurostimulation procedures N. hypoglossal. In mild to moderate obstructive sleep apnea syndrome (OSAS), MAD, back suppression and weight reduction are potential treatment options. This study aims to identify possible side effects in the temporomandibular system that occur during nocturnal support of a mandibular arch over two years. Two different MADs are compared in terms of construction, height (bite elevation) and protrusion mechanics: the H-MAD with an hinge system according to Herbst and the SomnoDent Fusion ™ MAD (called F-MAD) with sliding side wings.

In addition, it is to be evaluated whether hinge system according to Herbst as a protrusion-controlling element and the reduction of the splint body for a reduced bite elevation leads to a significant reduction of side effects compared to the F-MAD.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Side effects of mandibular advancement devices in obstructive sleep apnea patients - observational results of a randomized controlled trial.
   Bernhardt O, Giannakopoulos NN, Kares H, Meyer A, et al · · 2026 · PMID 41634250 · DOI 10.1007/s11325-026-03576-4