Side Effects of Mandibular Advancement Devices

NACompletedINTERVENTIONAL
Enrollment

65

Participants

Timeline

Start Date

December 1, 2019

Primary Completion Date

December 1, 2022

Study Completion Date

December 21, 2022

Conditions
Obstructive Sleep Apnea SyndromeTemporomandibular Disorders
Interventions
DEVICE

H-MAD with a hinge system according to Herbst

"The randomized grouping into blocks at a ratio of 1: 1 takes place over sealed envelopes containing the allocation key for the respective MAD. The assignment is stratified according to gender because gender is a strong predictor of sleep disorders and also temporomandibular dysfunctions Integration of the MAD (start of treatment) The laboratory-made MAD (F-MAD / H-MAD) is integrated and checked for a comfortable fit. The patient is instructed to always wear the splint during sleep.~All patients receive an extended guide to jaw gymnastics with the instruction to do it in the morning after waking up and in the evening before falling asleep.~Four weeks after incorporation, the titration phase begins, the slow adjustment of mandibular advancement to optimize sleep medical parameters while minimizing unwanted side effects.~Control appointments take place after four weeks, six months, one year and two years after insertion of the MAD"

Trial Locations (9)

22607

Dental Office Dr. Schlieper, Hamburg

30916

Dental Office Dr. Hauschild, Isernhagen-Süd

42719

Dental Office Dr. Meyer, Solingen

60313

Dental Office Dr. Krumholz, Frankfurt

66121

Dental Office Dr. Kares, Saarbrücken

66280

Dental Office Dr. Nauert, Sulzbach

66740

Dental Office Dr. Heckmann, Saarlouis

76135

Zahnarztpraxis Weststadt, Karlsruhe

97070

Mund-Zahn-Kiefer-Klinik, Würzburg

All Listed Sponsors
lead

University Medicine Greifswald

OTHER

NCT04050514 - Side Effects of Mandibular Advancement Devices | Biotech Hunter | Biotech Hunter