Mandibular Advancement Devices for Reflux in Obstructive Sleep Apnea

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

August 1, 2025

Primary Completion Date

August 1, 2026

Study Completion Date

December 1, 2026

Conditions
Gastroesophageal Reflux Disease
Interventions
DEVICE

Mandibular Advancement Device

A custom-made intraoral appliance designed to reposition the mandible forward during sleep. The device increases the upper airway space by maintaining the lower jaw in a protruded position, aiming to reduce airway collapse and decrease nocturnal gastroesophageal reflux. It is fabricated from heat-cured acrylic based on individual dental impressions and bite registrations taken in a protruded mandibular position.

DEVICE

Lower Oral Device Without Mandibular Advancement

A lower jaw oral appliance made of heat-cured acrylic, fabricated from standard dental impressions and bite registration in habitual occlusion. This device does not reposition the mandible but provides posterior dental disocclusion. It is also used in patients with obstructive sleep apnea and serves as an active comparator to evaluate the specific impact of mandibular advancement on nocturnal gastroesophageal reflux.

Trial Locations (1)

Unknown

Universidade Tuiuti do Paraná - Centro de Diagnóstico das Alterações Temporomandibulares (CDATM), Curitiba

All Listed Sponsors
lead

Tuiuti University of Paraná

OTHER