Superimposition of Intra-oral Scans in MAD Therapy for OSA
ConditionObstructive Sleep Apnea
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAmsterdam UMC, location VUmc
About this trial
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 to track these changes and compare two adjustment methods for MAD to find the best approach for patients.
Goals:
1. To track dental and jaw changes in OSA patients using 3D scans. 2. To assess the impact of MAD on quality of life and cognitive function.
Study Details:
The aim of the study is to follow OSA patients at multiple centers over several years, comparing two MAD adjustment methods. Participants will undergo routine fitting and imaging.
Outcome:
The study aims to reduce dental and jaw changes and to improve MAD treatment and patient outcomes.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Mandibular Advancement Device
Treatment groups
250 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Amsterdam UMC, location VUmc
Lead sponsor
Academic Centre for Dentistry in Amsterdam
Collaborator
Source ClinicalTrials.gov