Apnea
Conditions
Brief 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).
Interventions
DEVICEConventional 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.
DEVICECAD 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
PROCEDUREUvuloplatopharyngeoplasty UPPP
uvulopalatopharyngeoplasty UPPP were performed by the same ENT surgeon under GA.
Sponsors
Nourhan M.Aly
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea hypopnea index | 4 months | The AHI measures an average number of apnea and hypopnea episodes that you experience per hour. According to the American Academy of Sleep Medicine (AASM) it is categorized into mild (5-15 events/hour), moderate (15-30 events/hr), and severe (\> 30 events/hr) |
| Epwoth sleeplness scale (ESS) | 4 months | The ESS is a subjective measure of a patient's sleepiness. The test is a list of eight situations in which the patien rates their tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing. All scores on the ESS fall between 0 and 24. Scores from 0 to 10 reflect normal levels of daytime sleepiness, and scores over 10 are considered to reflect excessive daytime sleepiness. |
| Oxygen saturation | 4 months | This will be measured using an oximeter. A normal level of oxygen is usually 95% or higher. |
| Snoring index | 4 months | Snoring index measures the total number of snores per hour of sleep. This is calculated by dividing your total sleeping time by your snoring frequency. The normal range depends on the person's gender and the stage of sleep |
Countries
Egypt
Outcome results
None listed