Efficacy of Different Treatments for Obstructive Sleep Apnea
NCT ID: NCT06352658
Last Updated: 2025-01-30
Study Results
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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COMPLETED
NA
45 participants
INTERVENTIONAL
2023-02-01
2024-01-10
Brief Summary
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1. Conventionally constructed mandibular advancement device (MAD).
2. Digitally constructed mandibular advancement device (CAD CAM).
3. Uvulopalatopharyngeoplasty (UPPP).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Conventional mandibular advancement 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.
CAD CAM mandibular advancement 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
Uvuloplatopharyngeoplasty UPPP
Uvuloplatopharyngeoplasty UPPP
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.
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
Uvuloplatopharyngeoplasty UPPP
uvulopalatopharyngeoplasty UPPP were performed by the same ENT surgeon under GA.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Years
50 Years
ALL
No
Sponsors
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Nourhan M.Aly
OTHER
Responsible Party
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Nourhan M.Aly
Assistant Lecturer of Dental Public Health
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
Countries
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Other Identifiers
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#1/2024
Identifier Type: -
Identifier Source: org_study_id
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