Efficacy of Different Treatments for Obstructive Sleep Apnea

Nourhan M.Aly

Status: Completed

Conditions: Apnea

Treatments: Device: CAD CAM mandibular advancement device; Procedure: Uvuloplatopharyngeoplasty UPPP; Device: Conventional mandibular advancement device

Study type: Interventional

Funder types: Other

Identifiers

NCT06352658

#1/2024

Details and patient eligibility

About

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).

Enrollment: 45 patients

Sex: All

Ages: 30 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adequate nasal air flow capacity as determined by qualified otolaryngologist
• Cases showing improvement in airway with mandibular advancement on Acoustic Pharyngometry (AP)
• Patients with the minimum component of dentition to support MDSA.
• Patients with the mandibular protrusive movement of more than 5 mm
• Body mass index (BMI) less than 30 kg/m2

Exclusion criteria

• Severe nasal passage obstructions or allergies
• Obesity (BMI greater than 30 kg/m2 )
• Cases with Mallampati score greater than Class 1
• Systemic complications, syndrome, or disease affecting airway
• Severe periodontal disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Conventional mandibular advancement device

Active Comparator group

Treatment:

Device: Conventional mandibular advancement device

CAD CAM mandibular advancement device

Experimental group

Treatment:

Device: CAD CAM mandibular advancement device

Uvuloplatopharyngeoplasty UPPP

Experimental group

Treatment:

Procedure: Uvuloplatopharyngeoplasty UPPP