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IOA Preventing Occlusal Changes With MAD Use
Effectiveness of Interocclusal Aligner (IOA) on Preventing Occlusal Changes in Patients Treated With a Mandibular Advancement Device (MAD): A Preliminary Study
Who can join
Ages 18 and older · All sexes · Healthy volunteers welcome
Full eligibility 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
About the study
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.
What is being tested
- AM Aligner (device)
- Exercise (behavioral)
Sponsor: Isabel Moreno Hay · Participants: 30 · Started: Nov 17, 2025
Contact the study team
- Salma Habib, BDS · Phone: 8593235500
- Isabel Moreno Hay, MS, PhD · Phone: 8593235500
Official record on ClinicalTrials.gov — NCT07103941
Locations in the U.S.
| Kentucky | Orofacial Pain Center - University of Kentucky - Kentucky Clinic, Lexington |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.