Acceptance of Mandibular Advancement Devices

NCT06970171 | Enrolling By Invitation

• 1 other identifier: MAD08042025
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

acceptance; side effects; mandibular advancement device; clinical intervention; treatment

Outcome Measures

Primary Outcomes (1)

• Acceptance of the MAD

  wearing comfort of the MAD, assessed using a numeric rating scale (NRS; 0-10) at follow-up time points

  4 weeks, 6 months, 12 months

Secondary Outcomes (4)

• Orofacial Pain

  4 weeks, 6 months, 12 months

• Pressure Pain in the Temporomandibular Joint and Masticatory Muscles

  4 weeks, 6 months, 12 months

• Number of Posterior Contact Points

  4 weeks, 6 months, 12 months

• GEDAS (Greifswald Digital Analyzing System)

  12 months

Other Outcomes (4)

• Epworth Sleepiness Scale (ESS)

  4 weeks, 6 months, 12 months

• Apnea-Hypopnea Index (AHI)

  12 months

• Desaturation Index (DI)

  12 months

Study Arms (2)

Patients randomly selected for arm 1 MAD treatment

EXPERIMENTAL

Patients with primary snoring or with a medical indication for MAD therapy due to OSAS. Patients age must be ≥ 18 and ≤ 75 years. Patients must have a mandibular advancement of at least 5 mm possible (titration starts at 5 mm). Patients must have at least 8 teeth or 4 implants per jaw or with fixed prosthetics or stable removable partial dentures, bilateral support extending to at least the second premolars.

Device: MAD of the Scheu Dental type with lateral guidance wings (MAD-1)

Patients randomly assigned to arm 2 MAD treatment.

ACTIVE COMPARATOR

Patients with primary snoring or with a medical indication for MAD therapy due to OSAS. Patients age must be ≥ 18 and ≤ 75 years. Patients must have a mandibular advancement of at least 5 mm possible (titration starts at 5 mm). Patients must have at least 8 teeth or 4 implants per jaw or with fixed prosthetics or stable removable partial dentures, bilateral support extending to at least the second premolars.

Device: MAD of the Panthera X3 type with lateral guidance wings (MAD-2)

Interventions

MAD of the Scheu Dental type with lateral guidance wings (MAD-1) DEVICE

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.

Patients randomly selected for arm 1 MAD treatment

MAD of the Panthera X3 type with lateral guidance wings (MAD-2) DEVICE

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.

Patients randomly assigned to arm 2 MAD treatment.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medical indication for MAD therapy due to OSAS
• Mandibular advancement of at least 5 mm possible
• Fixed prosthetics or stable removable partial dentures
• Bilateral support extending to at least the second premolars
• Legal capacity and signed informed consent

You may not qualify if:

• Polyarthritis
• Mouth opening \< 30 mm
• More than two prior therapy attempts
• Fibromyalgia, neuralgia
• Central sleep apnea syndrome
• Pulmonary diseases
• Untreated generalized periodontitis
• Chronic dysfunctional pain (GCPS Grade 3-4)
• Long-term use of psychotropic or analgesic medications

Sponsors & Collaborators

• University Medicine Greifswald: lead

Study Sites (1)

University Medicine Greifswald, Department of Restorative Dentistry, Periodontology and Endodontology

Greifswald, Mecklenburg-Vorpommern, 17475, Germany

Location

Related Publications (17)

• Abe S, Huynh NT, Romprss PH, de Grandmont P, Landry-Schonbeck A, Landry ML, Kato T, Kawano F, Lavigne GJ. Sleep Quality and Comfort Reported by Sleep Bruxism Individuals Wearing the Occlusal Splint and Mandibular Advancement Splint: Revisiting Two Crossover Studies. Int J Prosthodont. 2023 May;36(2):138-147. doi: 10.11607/ijp.7525. Epub 2023 May 24.

  PMID: 36484654 BACKGROUND

• Uniken Venema JAM, Doff MHJ, Joffe-Sokolova DS, Wijkstra PJ, van der Hoeven JH, Stegenga B, Hoekema A. Dental side effects of long-term obstructive sleep apnea therapy: a 10-year follow-up study. Clin Oral Investig. 2020 Sep;24(9):3069-3076. doi: 10.1007/s00784-019-03175-6. Epub 2019 Dec 20.

  PMID: 31863188 BACKGROUND

• 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.

  PMID: 20831889 BACKGROUND

• Fransson AM, Svenson BA, Isacsson G. The effect of posture and a mandibular protruding device on pharyngeal dimensions: a cephalometric study. Sleep Breath. 2002 Jun;6(2):55-68. doi: 10.1007/s11325-002-0055-7.

  PMID: 12075480 BACKGROUND

• 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.

  PMID: 15387030 BACKGROUND

• 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.

  PMID: 22477031 BACKGROUND

• Gislason T, Janson C, Vermeire P, Plaschke P, Bjornsson E, Gislason D, Boman G. Respiratory symptoms and nocturnal gastroesophageal reflux: a population-based study of young adults in three European countries. Chest. 2002 Jan;121(1):158-63. doi: 10.1378/chest.121.1.158.

  PMID: 11796445 BACKGROUND

• Pelttari L, Rauhala E, Polo O, Hyyppa MT, Kronholm E, Viikari J, Kantola I. Upper airway obstruction in hypothyroidism. J Intern Med. 1994 Aug;236(2):177-81. doi: 10.1111/j.1365-2796.1994.tb01280.x.

  PMID: 8046317 BACKGROUND

• Tingting X, Danming Y, Xin C. Non-surgical treatment of obstructive sleep apnea syndrome. Eur Arch Otorhinolaryngol. 2018 Feb;275(2):335-346. doi: 10.1007/s00405-017-4818-y. Epub 2017 Nov 24.

  PMID: 29177626 BACKGROUND

• Mohsenin V. Is sleep apnea a risk factor for stroke? A critical analysis. Minerva Med. 2004 Aug;95(4):291-305.

  PMID: 15334043 BACKGROUND

• Gottlieb DJ, Chase C, Vezina RM, Heeren TC, Corwin MJ, Auerbach SH, Weese-Mayer DE, Lesko SM. Sleep-disordered breathing symptoms are associated with poorer cognitive function in 5-year-old children. J Pediatr. 2004 Oct;145(4):458-64. doi: 10.1016/j.jpeds.2004.05.039.

  PMID: 15480367 BACKGROUND

• Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5. doi: 10.1056/NEJM199304293281704.

  PMID: 8464434 BACKGROUND

• Lugaresi E, Cirignotta F, Coccagna G, Piana C. Some epidemiological data on snoring and cardiocirculatory disturbances. Sleep. 1980;3(3-4):221-4. doi: 10.1093/sleep/3.3-4.221. No abstract available.

  PMID: 7221330 BACKGROUND

• Cook RJ, Farewell VT. On multiplicity considerations in the design and analysis of clinical trials. J Roy Statist Soc 1996;159:93-110.

  BACKGROUND

• 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.

  PMID: 12867898 BACKGROUND

• 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.

  PMID: 25905532 BACKGROUND

• 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.

  PMID: 11690728 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Olaf Bernhardt, Prof. Dr. med.dent.

  University Medicine Greifswald

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. dent.

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: May 14, 2025
• Study Start: May 5, 2025
• Primary Completion (Estimated): May 5, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)