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IOA Preventing Occlusal Changes With MAD Use

Isabel Moreno Hay · with American Academy of Orofacial Pain · NCT07103941

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
30
US sites recruiting
1
Study start
November 17, 2025
Record last updated
May 18, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: AM Aligner; Exercise

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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Orofacial Pain Center - University of Kentucky - Kentucky Clinic

    Lexington, KY 40536

    Site contact: Salma Habib, BDS · 8593235500 · skha265@uky.edu

Study contacts (from the official record)

  • Salma Habib, BDS · 8593235500 · skha265@uky.edu
  • Isabel Moreno Hay, MS, PhD · 8593235500 · orofacialpain@uky.edu
All sleep studies in Kentucky →
IOA Preventing Occlusal Changes With MAD Use (NCT07103941) | Bored Studies