Actively Recruiting
IOA Preventing Occlusal Changes With MAD Use
Led by Isabel Moreno Hay · Updated on 2025-12-04
30
Participants Needed
1
Research Sites
23 weeks
Total Duration
On this page
Sponsors
I
Isabel Moreno Hay
Lead Sponsor
A
American Academy of Orofacial Pain
Collaborating Sponsor
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
IOA Preventing Occlusal Changes With MAD Use
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult participants aged 18 years or older
- Diagnosed with a sleep-related breathing disorder and prescribed Mandibular Advancement Device (MAD) therapy
- Have well-restored natural teeth including all back teeth except third molars, with allowance for one missing premolar due to orthodontic treatment
You will not qualify if you...
- Previous orthognathic (jaw) surgery
- Having anterior or posterior crossbite
- Existing open bite or implant-supported dental restorations
- Tooth mobility
- Significant dental decay or gum disease
- Severe teeth grinding (bruxism)
- Planned dental work such as crowns, implants, braces, or caps
- Inadequate ability to move the lower jaw forward (mandibular protrusion)
- Severe small jaw (micrognathia)
- Large bony growths in the mouth (tori)
- Significant claustrophobia
- Significant nasal blockage
- Large throat masses or enlarged tonsils
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Orofacial Pain Center - University of Kentucky - Kentucky Clinic
Lexington, Kentucky, United States, 40536
Actively Recruiting
Research Team
S
Salma Habib, BDS
CONTACT
I
Isabel Moreno Hay, MS, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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