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Efficacy of Different Treatments for Obstructive Sleep Apnea

NCT06352658 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-01-30

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Nourhan M.Aly

    lead OTHER

Principal Investigators

  • Mona Sabry, PhD · Faculty of Dentistry, Alexandria University, Egypt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2024-01-01
Completion
2024-01-10

Countries

  • Egypt

Study Locations

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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 NCT06352658 on ClinicalTrials.gov