IOA Preventing Occlusal Changes With MAD Use
Launched by ISABEL MORENO HAY · Jul 29, 2025
Trial Information
Current as of September 09, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying ways to prevent changes in how your teeth fit together (called bite changes) when using a Mandibular Advancement Device (MAD). A MAD is a mouthpiece often prescribed to help with sleep-related breathing problems like snoring and obstructive sleep apnea (OSA). While MADs can improve breathing during sleep, they sometimes cause changes in your bite, such as gaps forming between your back teeth. This study compares two common methods to reduce these bite changes: wearing a special aligner after taking out the MAD each morning, or doing daily jaw exercises.
Adults who have been prescribed a MAD for sleep breathing issues and have most of their natural back teeth (with some exceptions) may be eligible to join. People with certain dental problems, past jaw surgery, or other specific health issues will not qualify. Participants will be followed for about three months, during which they will have dental check-ups, 3D scans of their mouth, and complete short daily surveys about their experience. The goal is to find the best way to protect your bite while still benefiting from MAD therapy.
Gender
ALL
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 Isabel Moreno Hay
Isabel Moreno Hay is a dedicated clinical trial sponsor with a focus on advancing medical research and improving patient outcomes. With expertise in designing and managing clinical studies, the organization emphasizes ethical practices, rigorous scientific methodologies, and collaboration with healthcare professionals. Committed to innovation and excellence, Isabel Moreno Hay aims to facilitate the development of new therapies and treatments across various therapeutic areas, ensuring that patient safety and data integrity remain paramount throughout the research process.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Lexington, Kentucky, United States
Patients applied
Trial Officials
Isable Moreno Hay, MS, PhD
Study Director
University of Kentucky
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported