IOA Preventing Occlusal Changes With MAD Use

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Isabel Moreno Hay
Study ID
NCT07103941
Status
Recruiting
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Conditions

  • Obstructive Sleep Apnea (OSA)
  • Occlusal Changes
  • Open Bite
  • Posterior Open Bite
  • Sleep Related Breathing Disorder
  • Snoring
  • Tooth Migration

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • AM Aligner — DEVICE
    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 — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Nov 17, 2025
Status verified
May 2026
Primary completion
Nov 28, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Orofacial Pain Center - University of Kentucky - Kentucky ClinicLexingtonKentucky40536
Salma Habib, BDS
[email protected]
8593235500

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By research site
Orofacial Pain Center - University of Kentucky - Kentucky Clinic· Lexington, KY

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