NCT06352658

Efficacy of Different Treatments for Obstructive Sleep Apnea

Efficacy of Different Treatment Modalities for Obstructive Sleep Apnea: a Randomized Controlled Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Nourhan M.Aly · Academic / Other
• Sex: All
• Age: 30 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This was a prospective randomized controlled clinical trial that aimed to evaluate the efficacy of three treatments for obstructive sleep Apnea OSA: 1. Conventionally constructed mandibular advancement device (MAD). 2. Digitally constructed mandibular advancement device (CAD CAM). 3. Uvulopalatopharyngeoplasty (UPPP).

Conditions

• Apnea

Interventions

Type	Name	Description
DEVICE	Conventional mandibular advancement device	With a vacuum mahine (Biostar, NY) a 2-mm-thick hard, clear resin sheet was adapted to the cast. The excess material was cut, borders were trimmed and smoothed. Maxillary mandibular casts were mounted by a protrusive the interocclusal record. The appliances were re-placed on the mounted casts to be splinted to form a Monoblock MAD by autopolymerizing acrylic resin at the premolar -molar area.
DEVICE	CAD CAM mandibular advancement device	3D models for the stone casts were constructed with laser scanning machine (accuracy \<20 µm; D500, 3shape). Maxillary and mandibular casts were rescanned in the achieved 75% advancement position and monoblock device was designed by CAD (computer-aided design) with 3D software (3-matic; Materialise) and printed by
PROCEDURE	Uvuloplatopharyngeoplasty UPPP	uvulopalatopharyngeoplasty UPPP were performed by the same ENT surgeon under GA.

Timeline

• Start date: 2023-02-01
• Primary completion: 2024-01-01
• Completion: 2024-01-10
• First posted: 2024-04-08
• Last updated: 2025-01-30

Locations

1 site across 1 country: Egypt