IOA Preventing Occlusal Changes With MAD Use

NANot yet recruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

November 3, 2025

Primary Completion Date

February 28, 2026

Study Completion Date

March 30, 2026

Conditions
Sleep Related Breathing DisorderSnoringObstructive Sleep Apnea (OSA)Open BiteOcclusal ChangesTooth MigrationPosterior Open Bite
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."

Trial Locations (1)

40536

Orofacial Pain Center - University of Kentucky - Kentucky Clinic, Lexington

All Listed Sponsors
collaborator

American Academy of Orofacial Pain

UNKNOWN

lead

Isabel Moreno Hay

OTHER

NCT07103941 - IOA Preventing Occlusal Changes With MAD Use | Biotech Hunter | Biotech Hunter