Status:
NOT_YET_RECRUITING
Superimposition of Intra-oral Scans in MAD Therapy for OSA
Lead Sponsor:
Amsterdam UMC, location VUmc
Collaborating Sponsors:
Academic Centre for Dentistry in Amsterdam
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18+ years
Brief Summary
Obstructive Sleep Apnea (OSA) affects quality of life and health. Mandibular Advancement Devices (MAD) can help with OSA but may cause dental and jaw changes. This study uses a new 3D scanning method ...
Detailed Description
Rationale: Obstructive Sleep Apnea (OSA) significantly reduces quality of life and increases the risk of severe health issue. While Mandibular Advancement Devices (MAD) are effective in managing OSA s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2029
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06612008
Start Date
July 1 2025
End Date
July 1 2029
Last Update
July 10 2025
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