# Side effects of mandibular advancement devices in obstructive sleep apnea patients – observational results of a randomized controlled trial

## TL;DR

This study compared side effects of two mandibular advancement devices used to treat sleep apnea and found both caused similar orofacial pain and posterior tooth contact loss.

## Contribution

The study provides observational evidence on side effects of two MAD designs in a randomized controlled trial setting.

## Key findings

- Both MADs caused similar levels of orofacial pain, though results were not statistically significant.
- Posterior tooth contact loss was significant in both MAD groups despite jaw exercises and occlusal guides.
- Somnological variables improved over time with no major differences between MAD designs.

## Abstract

To identify side effects of two different mandibular advancement devices (MAD) for treating obstructive sleep apnea.

Sixty-five patients were randomly assigned to two MADs (MAD 1 with bilateral sliding wings, MAD 2 with bilateral bars according to the Herbst appliance). Instructions for supportive jaw exercises and a morning occlusal guide were supplied. Orofacial pain, tenderness of masticatory muscles and temporomandibular joints, interdental contact analysis (digital bite registration system, Greifswald Digital Analyzing System (GEDAS) and Shimstock-foil), Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index, and the Oral Health Impact Profile 5 were assessed before and after one year of treatment. MADs were compared using linear models, which were adjusted for study center, age, sex, and baseline values. Tooth type and tooth status were also included in the multilevel model of interdental contacts.

This study did not contradict the supposition that both MADs yield the same mean for the primary outcome, orofacial pain (P = 0.107; n = 49), possibly because of the reduced sample size due to the COVID-19 pandemic. Significant loss of posterior tooth contacts (n = 37) was established when applying the digital analysis for both MADs. Somnological variables were decreased in the follow-up examination, with no relevant differences between both MAD designs.

For comparing pain in MAD groups, more data will be needed to pool in meta-analyses. However, in our study, loss of interocclusal contacts in posterior teeth could not be prevented by jaw exercises or the use of an occlusal guide.

ClinicalTrials.gov ID: NCT04050514, 08/01/2019.