Superimposition of Intra-oral Scans in MAD Therapy for OSA

Launched by AMSTERDAM UMC, LOCATION VUMC · Sep 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how a device called a Mandibular Advancement Device (MAD) can help people with Obstructive Sleep Apnea (OSA), a condition that affects breathing during sleep. The trial will use a new 3D scanning technique to monitor any changes in the teeth and jaw that may occur while using the device. Researchers want to compare two different ways of adjusting the MAD to determine which one works best for improving patients' sleep quality and overall health.

To participate in the study, you need to be an adult aged 18 or older and have a diagnosis of mild to moderate OSA. If you join the study, you will receive routine fittings for the device and undergo regular imaging to track your progress over several years. The goal is to find ways to reduce any dental or jaw issues related to MAD use while enhancing the benefits of the treatment for patients. Please note that there are certain conditions that might exclude you from participating, such as being under 18, having severe dental problems, or undergoing other treatments for OSA.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adults ≥ 18 years of age
• • Patients with a diagnosis of OSA
• • Patients with an apnea-hypopnea index (AHI) of 5 until 30 events per hour
• • Patients initially treated with MAD
• Exclusion Criteria:
• • Patients under 18 years of age
• • Patients without a diagnosis of mild to moderate OSA
• • Patients undergoing other treatments for OSA
• • Patients previously undergone MAD treatment (this also includes over the counter boil and bite MADs)
• • Patients diagnosed with central sleep apnea
• • Patients undergoing orthodontic treatment (e.g. braces)
• • Pregnant patients
• • Patients with craniofacial anomalies or syndromes (e.g., Treacher-Collins, Down, Pierre-Robin, Marfan),
• • Patients undergoing cancer treatment with chemotherapy or radiation
• • Patients with a history of maxillofacial surgery
• • Patients with select dental conditions like severe periodontal disease, temporomandibular joint disease, insufficient dentition to support appliance retention in the mouth
• • Patients who use bone resorption inhibitors (such as bisphosphonates, calcitonin, SERMs) or the prolonged use, ≥ 6 months of corticosteroids