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

Abstract Purpose To identify side effects of two different mandibular advancement devices (MAD) for treating obstructive sleep apnea. Methods 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. Results 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. Conclusion 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.