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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional mandibular advancement device | Active Comparator |
| |
| CAD CAM mandibular advancement device | Experimental |
| |
| Uvuloplatopharyngeoplasty UPPP | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional mandibular advancement device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Apnea hypopnea index | 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) | 4 months |
| Epwoth sleeplness scale (ESS) | 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. | 4 months |
| Oxygen saturation | This will be measured using an oximeter. A normal level of oxygen is usually 95% or higher. | 4 months |
| Snoring index | 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 | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mona Sabry, PhD | Faculty of Dentistry, Alexandria University, Egypt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Alexandria University, Egypt | Alexandria | Egypt |
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| ID | Term |
|---|---|
| D001049 | Apnea |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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|
| CAD CAM mandibular advancement device | 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 | Procedure | uvulopalatopharyngeoplasty UPPP were performed by the same ENT surgeon under GA. |
|
| D013568 | Pathological Conditions, Signs and Symptoms |