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

This trial does not accept healthy volunteers

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 population

The participants of the research will be recruited from the Department of Oral and Maxillofacial Surgery at 'Isala Hospital Zwolle' and from the orthodontic practice 'Orthodontisten Heemstede', both located in the Netherlands.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Mandibular Advancement Device
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.

Treatment groups

250 Participants

are divided into 2 treatment groups

Group A: Stepwise titration1 intervention

Group B: Personalized titration1 intervention

Trial outcomes

Primary outcomes

Dental occlusal measurements

* Overbite (mm): the vertical overlap of the upper and lower teeth. * Overjet (mm): the horizontal overlap of the upper and lower teeth. * Maximal protrusion (mm): the most protrusive position of the mandible, independent of tooth contact. * Maximal retrusion (mm): the most retrusive position of the mandible, independent of tooth contact. * Protrusive range (mm): the distance between the most protrusive and most retrusive position of the mandible. * Maximal mouth opening (mm): the maximum distance between the upper and lower incisors when the mouth is fully opened.

Time frame