Side Effects of Two Different Mandibular Advancement Devices (MAD) in the Treatment of Snoring and Obstructive Sleep Apnea Syndrome (OSAS)

Status: Completed
Location: See all (9) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Patients with medical indication for mandibular protrusion (MAD) due to OSAS

• therapy request for snoring

• Body Mass Index (BMI) ≤ 35

• mandibular protrusion of 5 mm possible

• at least 8 remaining teeth or 4 implants per jaw

• fixed dentures and stable

• removable partial denture, at least support up to the area of the 2nd premolars on both sides

• business ability and the existence of the signed declaration of consent

Locations
Other Locations
Germany
Dental Office Dr. Krumholz
Frankfurt
Dental Office Dr. Schlieper
Hamburg
Dental Office Dr. Hauschild
Isernhagen-süd
Zahnarztpraxis Weststadt
Karlsruhe
Dental Office Dr. Kares
Saarbrücken
Dental Office Dr. Heckmann
Saarlouis
Dental Office Dr. Meyer
Solingen
Dental Office Dr. Nauert
Sulzbach
Mund-Zahn-Kiefer-Klinik
Würzburg
Time Frame
Start Date: 2019-12-01
Completion Date: 2022-12-21
Participants
Target number of participants: 65
Treatments
Experimental: H-MAD, hinge system according to Herbst
Patients with snoring and OSAS. Therapy with MAD type H-MAD with lateral hinges according to Herbst.~Bite elevation 2 mm interocclusal distance with a lower jaw advancement of 5 mm
Active_comparator: F-MAD, SomnoDent Fusion
Patients with snoring and OSAS,Fusion MAD with sliding side wings (F-MAD). Bite elevation 5 mm interocclusal distance with a lower jaw advancement of 5 mm
Related Therapeutic Areas
Sponsors
Leads: University Medicine Greifswald

This content was sourced from clinicaltrials.gov

Similar Clinical Trials

We couldn't find any related articles check for more on the main search page.