Recruiting

MAD with Aligner & Exercises

Sponsor:

Isabel Moreno Hay

Code:

NCT07103941

Conditions

Sleep Related Breathing Disorder

Snoring

Obstructive Sleep Apnea (OSA)

Open Bite

Occlusal Changes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

AM Aligner

Exercise

Study Details

Brief 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.

Conditions

Sleep Related Breathing Disorder

Snoring

Obstructive Sleep Apnea (OSA)

Open Bite

Occlusal Changes

Study ID

NCT07103941

Start date

Nov 17, 2025

Status verified date

May, 2026

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Nov 28, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • pervious orthognathic surgery
  • anterior cross bite
  • posterior cross bite
  • existing open bite or implant supported restorations
  • tooth mobility
  • significant dental caries or periodontitis
  • severe bruxism
  • planned upcoming dental work including caps, crowns, implants, or braces
  • inadequate mandibular protrusion
  • severe micrognathia
  • large tori
  • significant claustrophobia
  • significant nasal obstruction
  • large oropharyngeal masses or large tonsils

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Interocclusal Aligner

Arm 1 (Interocclusal Aligner Group):

"Morning Interocclusal Aligner to Maintain Occlusion" Participants in this arm will use a prefabricated thermoplastic device called the AM Aligner each morning immediately after removing their Mandibular Advancement Device (MAD). The aligner will be warmed and then gently bitten into for 2-5 minutes to help reposition the mandible and maintain the original occlusion. This approach is a standard-of-care method aimed at minimizing occlusal changes associated with MAD therapy.

active comparator: Daily Jaw Exercises

Participants in this arm will be instructed to perform a standardized set of jaw exercises each morning after removing their MAD. The exercises include side-to-side jaw movements, backward pressure (such as the "thinker's pose"), and gentle simulated clenching.

Interventions

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.

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.

Primary outcome measure

  • Number of participants enrolled in the study [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Isabel Moreno Hay, MS, PhD

8593235500orofacialpain@uky.edu

Locations

Orofacial Pain Center - University of Kentucky - Kentucky Clinic

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

More Information

Sponsor

Isabel Moreno Hay

Last update posted

May 18, 2026

Last verified

May, 2026

Keywords

  • Interocclusal Aligner
  • Mandibular advancement Device
  • Posterior Open Bite
  • Occlusal Changes
  • Dental Changes
  • Protrusion
  • Sleep Appliance
  • Obstructive Sleep Apnea

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Isabel Moreno Hay on 2026-05-18.