IOA Preventing Occlusal Changes With MAD Use

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIsabel Moreno Hay

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

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Isabel Moreno Hay

Lead sponsor

University of Kentucky

Sponsor institution

American Academy of Orofacial Pain

Collaborator