Effects of Mandibular Advancing Device in Obstructive Sleep Apnea

The goal of this clinical trial is to learn if Mandibular advancing devices work to treat obstructive sleep apnea in adults. Selected Participants have a mild or moderate degree of obstructive sleep apnea.The main questions it aims to answer are:

Do Mandibular advancing devices (MADs) lower the number of times participants experience apneas or hypopneas during sleep? Do MADs lower Apnea Hypopnea Index in adults when worn during sleep?

Completed

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of dentistry AinShams University

Cairo, Abbaseya, 11766, Egypt

About this study

This clinical trial aims to evaluate comprehensively the effects of a custom made titrable bi-block mandibular advancing device on the respiratory variables in polysomnography. This includes the apnea hypopnea index and the oxygen desaturation index. Also sleep variables such as sleep efficiency and snoring duration are evaluated. Also cone beam computed tomography scans are taken before treatment and after 6 weeks of using te appliance. the second CBCT scan is taken with the appliance intra-orally. The cahnge in airway volume and minimal axial area are measured.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adults (18 years and older)
Mild/Moderate obstructive sleep apnea
Sufficient number of teeth( having at least one terminal molar)
Healthy teeth and Periodontal ligament
Good physical and mental capability helping the subjects to be able to deal with the appliance.

Exclusion criteria

Severe OSA,
Central sleep apnea,
Pregnant females
Somatic or psychological disease, or medications for psychological conditions.

Treatment and study plan

Mandibular advancement device

Device

Custom made titrable bi-bloc MADs worn during sleep to stabilize airway and treat obstructive sleep apnea

Primary outcomes

change in AHI

Time frame: frpm enrollment to assessment of outcomes at least 8weeks

difference between pre-tretment and post-treatment Apnea Hypopnea Index

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Evaluation of the Effects of Mandibular Advancing Device in Obstructive Sleep Apnea Patients

Acronym: (MADs)

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2025
First posted: Jun 4, 2025
Registry last updated: Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed