About this trial
This study is evaluating two standard-of-care strategies used to prevent bite changes (occlusal changes) in patients treated with a Mandibular Advancement Device (MAD) for sleep-related breathing disorders such as obstructive sleep apnea (OSA). While MAD therapy is effective, it can lead to changes in how the teeth fit together, including the development of a posterior open bite.
Participants in this study will be randomly assigned to one of two standard-of-care approaches: using an interocclusal aligner each morning after removing the MAD, or performing daily jaw exercises. Both methods aim to reduce the risk of occlusal changes.
The study will follow participants over a 3-month period and includes dental evaluations, 3D oral scans, and short daily surveys. Findings from this research may help guide best practices for preserving occlusion during MAD therapy.
Eligibility criteria
Qualifiers
adult participants (≥18 years)
diagnosed with SRBD and prescribed Mandibular Advancement Device (MAD) therapy
Participants will include patients with well restored natural dentition with all posterior teeth, excluding third molars, one missing premolar secondary to orthodontic treatment.
Disqualifiers
pervious orthognathic surgery
anterior cross bite
posterior cross bite
existing open bite or implant supported restorations
Trial design
Treatments tested in this trial
- AM Aligner
- Exercise
Treatment groups
Sponsors and collaborators
Isabel Moreno Hay
Lead sponsor
University of Kentucky
Sponsor institution
American Academy of Orofacial Pain
Collaborator