Side Effects of Mandibular Advancement Devices

NCT ID: NCT04050514

Last Updated: 2023-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2022-12-21

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.

Detailed Description

Sleep-related breathing disorders (SBAS), particularly obstructive sleep apnea syndrome (OSAS), are one of the most common causes of non-restorative sleep. Disturbances of sleep disorders include apneas and hypopneas associated with either or not pharyngeal obstruction and hypoventilation. Depending on the type of respiratory disorder present, they are associated with hypoxemia and may cause hypercapnia or acidosis The consequences of obstructive narrowing of the pharynx are far-reaching. Studies have shown that patients with OSAS have comorbidities such as neurological complaints, heart attacks, dementia, cardiovascular complaints, myocardial infarction, and a higher mortality rate.

Sleep fragmentation caused by respiratory disorders during sleep and wakefulness reactions (arousals) can lead to daytime sleepiness and concentration disorders. In the longer term untreated arousals and apneas are associated with an increased risk for arterial hypertension, stroke, myocardial infarction, diabetes mellitus and libido loss.

OSAS management includes positive pressure ventilation with continuous positive airway pressure (CPAP) masks, mandibular advancement of the mandible with mandibular advancement devices (MAD), weight loss, ear, nose and throat surgical procedures, bimaxillary or mandibular remodeling osteotomies, and neurostimulation procedures of the hypoglossal nerve.

Several studies have shown that the use of MADs is inferior in reducing the severity of OSAS in comparison to CPAP therapy, but its efficacy is comparable and preferred by patients in mild to moderate OSAS.

Due to the forward displacement of the lower jaw for several hours at night, similar symptoms as in temporomandibular dysfunction (TMD) patients may occur. The symptoms may be pain or stiffness on the masticatory muscles or temporomandibular joints.

This study aims to identify possible side effects in the temporomandibular system that occur during the course of two years of nocturnal MAD delivery. Two different appliance systems are compared in terms of construction height (bite elevation) and protrusion mechanics: the H-MAD ™ with a hinge system according to Herbst and the SomnoDent Fusion ™ (called F-MAD) with sliding side wings.

Conditions

Obstructive Sleep Apnea Syndrome; Temporomandibular Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

H-MAD with a hinge system according to Herbst

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

H-MAD with a hinge system according to Herbst

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• participation in another interventional clinical study (currently up to three months before inclusion)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medicine Greifswald

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olaf Bernhardt, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Medicine Greifswald

Locations

Dental Office Dr. Krumholz

Frankfurt, , Germany

Dental Office Dr. Schlieper

Hamburg, , Germany

Dental Office Dr. Hauschild

Isernhagen-Süd, , Germany

Zahnarztpraxis Weststadt

Karlsruhe, , Germany

Dental Office Dr. Kares

Saarbrücken, , Germany

Dental Office Dr. Heckmann

Saarlouis, , Germany

Dental Office Dr. Meyer

Solingen, , Germany

Dental Office Dr. Nauert

Sulzbach, , Germany

Mund-Zahn-Kiefer-Klinik

Würzburg, , Germany

Countries

Germany

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 11196228 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

001072019

Identifier Type: -

Identifier Source: org_study_id