Effectiveness of Interocclusal Aligner (IOA) on Preventing Occlusal Changes in Patients Treated With a Mandibular Advancement Device (MAD): A Preliminary Study

Summary

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.

Description

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

Yes

Interventions

• Device
  AM Aligner

  Intervention Name: AM Aligner (Interocclusal Aligner) Type: Device Manufacturer: (AM Aligner; TAP Sleep Care, Texas, USA) Description: The AM Aligner is a prefabricated, commercially available thermoplastic appliance designed to help patients return their mandible to a normal resting position after nighttime use of a Mandibular Advancement Device (MAD). In this study, the aligner will be used each morning immediately after removing the MAD. The participant will bite into the warmed aligner for 2-5 minutes to promote realignment of the mandible and occlusion. This approach aims to minimize or prevent occlusal changes, including posterior open bite and anterior shift, associated with prolonged MAD therapy. This intervention is distinct from the alternative study arm, which uses a set of guided jaw exercises instead of a physical appliance to achieve the same goal. The AM Aligner used in this study is a standard-of-care option and is FDA-cleared for this use. It is not investigational.

• Behavioral
  Exercise

  Participants in this arm will perform a standardized set of jaw exercises for 5 minutes each morning immediately after removing their Mandibular Advancement Device (MAD). The exercises are intended to assist in reestablishing the natural occlusal relationship following overnight mandibular advancement. This routine includes the following movements: Side-to-side jaw movements Backward pressure to the chin (similar to a "thinker's pose") Gentle simulated clenching The exercises are performed once daily and take approximately 2-3 minutes to complete. This approach represents a standard-of-care method for minimizing occlusal changes associated with MAD therapy.

Location