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.
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.
pervious orthognathic surgery
anterior cross bite
posterior cross bite
existing open bite or implant supported restorations
Parallel
AM Aligner
DeviceIntervention 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.
Exercise
BehavioralParticipants 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.
Number of participants enrolled in the study
Recruitment will be measured by tracking the number of participants who agree to enroll in a randomized clinical trial comparing stretching exercises to the use of an interocclusal aligner (IOA).
Change in posterior occlusal contact relationship from baseline
Intraoral scanning (IOS) and clinical occlusal assessment (using shim stock and articulating paper) will be used to detect the development of a posterior open occlusal relationship. Positional changes observed on follow-up scans will be compared to baseline 3D records and clinical measurements. Unit of Measure: Binary outcome (presence or absence of occlusal contact)
Change in axial inclination of maxillary incisors from baseline
Palatal tipping of the maxillary incisors will be evaluated using IOS and confirmed by clinical examination. Changes in tooth angulation will be compared to baseline 3D scans and clinical records. Unit of Measure: Degrees of axial inclination
Change in axial inclination of mandibular incisors from baseline
Proclination of mandibular incisors will be assessed by comparing IOS findings to baseline 3D records and corresponding clinical measurements. Unit of Measure: Degrees of axial inclination
Change in Mesial shifting of mandibular molars from baseline
Mesial displacement of mandibular molars will be measured using IOS and verified through clinical tooth position assessment, with comparisons made to baseline digital and clinical records. Unit of Measure: Millimeters (mm) of linear positional change
Click on the lead sponsor to view all of their trials.
Isabel Moreno Hay
Lead sponsor
University of Kentucky
Sponsor institution
American Academy of Orofacial Pain
Collaborator
