Side Effects of Mandibular Advancement Devices

NCT04050514 | Completed

• 1 other identifier: 001072019
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Obstructive Sleep Apnea Syndrome; Temporomandibular Disorders

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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

Other Outcomes (4)

• 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

Study Arms (2)

H-MAD, hinge system according to Herbst

EXPERIMENTAL

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

Device: H-MAD with a hinge system according to Herbst

F-MAD, SomnoDent Fusion

ACTIVE COMPARATOR

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

Device: H-MAD with a hinge system according to Herbst

Interventions

H-MAD with a hinge system according to Herbst DEVICE

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

F-MAD, SomnoDent Fusion; H-MAD, hinge system according to Herbst

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• polyarthritis
• fibromyalgia, neuralgia
• central sleep apnea syndrome
• untreated generalized periodontitis
• chronic dysfunctional pain degree 3-4
• long-term use of psychotropics and analgesics (\> 4 weeks)
• pregnancy

Sponsors & Collaborators

• University Medicine Greifswald: lead

Study Sites (9)

Dental Office Dr. Krumholz

Frankfurt, 60313, Germany

Location

Dental Office Dr. Schlieper

Hamburg, 22607, Germany

Location

Dental Office Dr. Hauschild

Isernhagen-Süd, 30916, Germany

Location

Zahnarztpraxis Weststadt

Karlsruhe, 76135, Germany

Location

Dental Office Dr. Kares

Saarbrücken, 66121, Germany

Location

Dental Office Dr. Heckmann

Saarlouis, 66740, Germany

Location

Dental Office Dr. Meyer

Solingen, 42719, Germany

Location

Dental Office Dr. Nauert

Sulzbach, 66280, Germany

Location

Mund-Zahn-Kiefer-Klinik

Würzburg, 97070, Germany

Location

Related Publications (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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.

  PMID: 11196228 BACKGROUND

• 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.

  PMID: 41634250 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Temporomandibular Joint Disorders; Snoring

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Olaf Bernhardt, Prof.

  University Medicine Greifswald

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Unblinded with respect to the examiner, blinded to the patient and statisticians in the evaluation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, randomized two-arm study with active control group, stratified by gender.

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: August 8, 2019
• Study Start: December 1, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 21, 2022
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (9)