Effectiveness of Interocclusal Aligner (IOA) on Preventing Occlusal Changes in Patients Treated With a Mandibular Advancement Device (MAD): A Preliminary Study

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
United States
Kentucky
Orofacial Pain Center - University of Kentucky - Kentucky Clinic
RECRUITING
Lexington
Contact Information
Primary
Salma Habib, BDS
skha265@uky.edu
8593235500
Backup
Isabel Moreno Hay, MS, PhD
orofacialpain@uky.edu
8593235500
Time Frame
Start Date: 2025-11-17
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 30
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Isabel Moreno Hay
Collaborators: American Academy of Orofacial Pain

This content was sourced from clinicaltrials.gov