NCT04050514|Completed
Side Effects of Mandibular Advancement Devices
Side Effects of Two Different Mandibular Advancement Devices (MAD) in the Treatment of Snoring and Obstructive Sleep Apnea Syndrome (OSAS)
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Side Effects of Two Different Mandibular Advancement Devices (MAD) in the Treatment of Snoring and Obstructive Sleep Apnea Syndrome (OSAS)
Sponsor study identifier
interventional
65
1 country
9
Study Start
December 1, 2019
Actual (reported)Primary Completion
December 1, 2022
Actual (reported)Study Completion
December 21, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 21, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 1, 2019
Actual (reported)August 8, 2019
Actual (reported)December 1, 2019
Actual (reported)December 1, 2022
Actual (reported)December 21, 2022
Actual (reported)change orofacial pain: numeric rating scale (NRS; 0-10)
change of orofacial pain after applying the MAD measured by numeric rating scale (NRS; 0-10, 0: no pain, 10: worst imaginable pain)
4 weeks, six months, one year, two years
pressure pain points on palpation
4 weeks, six months, one year, two years
number of posterior contact points
4 weeks, six months, one year, two years
change in sleep quality: Pittsburgh Sleep Quality Index (PSQI, 0-21, < 5: good sleep)
4 weeks, six months, one year, two years
change in daytime sleepiness: Epworth Sleepiness Scale (ESS, 0-24, <11 no daytime sleepiness)
4 weeks, six months, one year, two years
change in oral health-related quality of life: Oral Health Impact profile (OHIP-5) (0-20)
4 weeks, six months, one year, two years
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
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
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Dental Office Dr. Krumholz
Frankfurt, 60313, Germany
Dental Office Dr. Schlieper
Hamburg, 22607, Germany
Dental Office Dr. Hauschild
Isernhagen-Süd, 30916, Germany
Zahnarztpraxis Weststadt
Karlsruhe, 76135, Germany
Dental Office Dr. Kares
Saarbrücken, 66121, Germany
Dental Office Dr. Heckmann
Saarlouis, 66740, Germany
Dental Office Dr. Meyer
Solingen, 42719, Germany
Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.
Haviv Y, Rettman A, Aframian D, Sharav Y, Benoliel R. Myofascial pain: an open study on the pharmacotherapeutic response to stepped treatment with tricyclic antidepressants and gabapentin. J Oral Facial Pain Headache. 2015 Spring;29(2):144-51. doi: 10.11607/ofph.1408.
Olaf Bernhardt, Prof.
University Medicine Greifswald
65 participants (actual enrollment reported by the registry).
First Submitted
August 1, 2019
First Posted
August 8, 2019
Study Start
Titration of Oral Appliance Therapy: a Prospective, Randomized Cross-over Trial.
Contact the study team to confirm eligibility.
Dental Office Dr. Nauert
Sulzbach, 66280, Germany
Mund-Zahn-Kiefer-Klinik
Würzburg, 97070, Germany
Ringqvist M, Walker-Engstrom ML, Tegelberg A, Ringqvist I. Dental and skeletal changes after 4 years of obstructive sleep apnea treatment with a mandibular advancement device: a prospective, randomized study. Am J Orthod Dentofacial Orthop. 2003 Jul;124(1):53-60. doi: 10.1016/s0889-5406(03)00240-3.
Perez CV, de Leeuw R, Okeson JP, Carlson CR, Li HF, Bush HM, Falace DA. The incidence and prevalence of temporomandibular disorders and posterior open bite in patients receiving mandibular advancement device therapy for obstructive sleep apnea. Sleep Breath. 2013 Mar;17(1):323-32. doi: 10.1007/s11325-012-0695-1. Epub 2012 Apr 4.
Gesch D, Bernhardt O, Kocher T, John U, Hensel E, Alte D. Association of malocclusion and functional occlusion with signs of temporomandibular disorders in adults: results of the population-based study of health in Pomerania. Angle Orthod. 2004 Aug;74(4):512-20. doi: 10.1043/0003-3219(2004)0742.0.CO;2.
Doff MH, Hoekema A, Pruim GJ, Huddleston Slater JJ, Stegenga B. Long-term oral-appliance therapy in obstructive sleep apnea: a cephalometric study of craniofacial changes. J Dent. 2010 Dec;38(12):1010-8. doi: 10.1016/j.jdent.2010.08.018. Epub 2010 Sep 8.
Bacon W, Tschill P, Sforza E, Krieger J. [A device for mandibular advancement in respiratory disorders of sleep. Clinical study]. Orthod Fr. 2000 Dec;71(4):295-302. French.
Bernhardt O, Giannakopoulos NN, Kares H, Meyer A, Nurnberger CM, Ruge S, Schwahn C, Schlieper J, Yousif S, Zenner H, Kanzow P. Side effects of mandibular advancement devices in obstructive sleep apnea patients - observational results of a randomized controlled trial. Sleep Breath. 2026 Feb 3;30(1):32. doi: 10.1007/s11325-026-03576-4.
December 1, 2019
Primary Completion
December 1, 2022
Actual (reported)Study Completion
December 21, 2022
Actual (reported)Last Updated
June 15, 2023
Record last verified: 2023-06
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