Superimposition of Intra-oral Scans in MAD Therapy for OSA

NCT06612008 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2025-07-10

No results posted yet for this study

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 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.

Conditions

Interventions

DEVICE

Mandibular Advancement Device

MADs are custom-fitted oral appliances designed to reposition the mandible (lower jaw) forward during sleep, which helps to keep the airway open by preventing upper airway collapse.

Sponsors & Collaborators

  • Academic Centre for Dentistry in Amsterdam

    collaborator OTHER
  • Amsterdam UMC, location VUmc

    lead OTHER

Principal Investigators

  • J. de Lange, Prof. Dr. · Amsterdam University Medical Center

  • J.P.T.F. Ho, Dr. · Amsterdam University Medical Center

  • N.C.W. van der Kaaij, Dr. · Amsterdam University Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2028-12-31
Completion
2029-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06612008 on ClinicalTrials.gov