Preventing bite changes from mandibular advancement sleep devices with a morning aligner or jaw exercises.
Effectiveness of Interocclusal Aligner (IOA) on Preventing Occlusal Changes in Patients Treated With a Mandibular Advancement Device (MAD): A Preliminary Study
This test compares a removable morning interocclusal aligner to daily jaw exercises to see if they prevent bite changes in adults using mandibular advancement devices for sleep apnea or snoring.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Kentucky Academic / other |
| Locations | 1 site (Lexington, Kentucky) |
| Trial ID | NCT07103941 on ClinicalTrials.gov |
What this trial studies
Adults prescribed mandibular advancement devices (MADs) for sleep-related breathing disorders will be randomly assigned to one of two standard-of-care approaches: using an interocclusal aligner each morning after removing the MAD or performing a set of daily jaw exercises. Participants will be followed for three months with dental examinations, 3D oral scans, and brief daily surveys to monitor occlusion and symptoms. The study aims to measure differences in development of posterior open bite and other occlusal changes between the two groups. Results will inform practical strategies clinicians can use to reduce dental side effects of MAD therapy.
Who should consider this trial
Good fit: Adults (18+) diagnosed with sleep-related breathing disorders who have been prescribed a mandibular advancement device and have well-restored natural dentition with all posterior teeth (excluding third molars) are ideal candidates.
Not a fit: Patients with existing open bite, crossbites, implant-supported restorations, significant dental disease or tooth mobility, severe bruxism, recent orthognathic surgery, inadequate mandibular protrusion, or those unable to attend site visits are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the preferred approach could help patients keep their teeth alignment and reduce dental side effects so they can continue using MAD therapy comfortably.
How similar studies have performed: Dental side effects of MADs are well documented, but direct randomized comparisons of a morning interocclusal aligner versus daily jaw exercises to prevent occlusal changes are limited and this specific comparison is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lexington, Kentucky
- Orofacial Pain Center - University of Kentucky - Kentucky Clinic — Lexington, Kentucky, United States (Recruiting)
Study contacts
- Study coordinator: Salma Habib, BDS
- Email: skha265@uky.edu
- Phone: 8593235500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.