Efficacy of Different Treatments for Obstructive Sleep Apnea

NCT ID: NCT06352658

Last Updated: 2025-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2024-01-10

Brief Summary

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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).

Detailed Description

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Conditions

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Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conventional mandibular advancement device

Group Type ACTIVE_COMPARATOR

Conventional mandibular advancement device

Intervention Type 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.

CAD CAM mandibular advancement device

Group Type EXPERIMENTAL

CAD CAM mandibular advancement device

Intervention Type 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

Uvuloplatopharyngeoplasty UPPP

Group Type EXPERIMENTAL

Uvuloplatopharyngeoplasty UPPP

Intervention Type PROCEDURE

uvulopalatopharyngeoplasty UPPP were performed by the same ENT surgeon under GA.

Interventions

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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.

Intervention Type 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

Intervention Type DEVICE

Uvuloplatopharyngeoplasty UPPP

uvulopalatopharyngeoplasty UPPP were performed by the same ENT surgeon under GA.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nourhan M.Aly

OTHER

Sponsor Role lead

Responsible Party

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Nourhan M.Aly

Assistant Lecturer of Dental Public Health

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mona Sabry, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, Alexandria University, Egypt

Locations

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Faculty of Dentistry, Alexandria University, Egypt

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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#1/2024

Identifier Type: -

Identifier Source: org_study_id

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