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Side Effects of the Mandibular Advancement Device for Apnea Treatment on Dental Occlusion and Masticatory Function

NCT05420129 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2025-03-27

No results posted yet for this study

Summary

This study evaluates the effect of the use of mandibular advancement devices (MAD) on dental occlusion and masticatory function during the first two years of obstructive sleep apnea (OSA) treatment.

52 participants diagnosed with obstructive sleep apnea will be studied, 26 will be treated with MAD and 26 participants will be treated with continuous positive airway pressure (CPAP) as a control group.

Participants will perform masticatory tests to assess masticatory performance in comminute and mixing capacity. Masticatory satisfaction perceived by the participants will be evaluated by questionnaires. Occlusal contact area and other occlusal characteristics will be assessed using occlusal silicone and T-Scan registrations and 3D digital models obtained with intraoral scan. Data collection will be performed before treatment with MAD or CPAP, and at 3, 6, 12, and 24 months from the start of treatment.

Conditions

Interventions

DEVICE

MAD Therapy

Participants will be treated with a Mandibular Advancement Device therapy

DEVICE

CPAP Therapy

Participants will be treated with a Continuous Positive Airway Pressure therapy

Sponsors & Collaborators

  • University of Barcelona

    lead OTHER

Principal Investigators

  • Eva Willaert, DDS PhD · University of Barcelona

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-30
Primary Completion
2030-05-31
Completion
2032-05-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

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 NCT05420129 on ClinicalTrials.gov