Efficacy of Mandibular Advancement Device for Mild-Moderate Apnea

Apnea Clinical Trial

Official title:

Efficacy of Mandibular Advancement Device for Mild-Moderate Apnea: A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06352658
• Other study ID #: #1/2024
• Status: Completed
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: January 10, 2024

Study information

• Verified date: April 2024
• Source: University of Alexandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This was a prospective randomized controlled clinical trial that aimed to compare the efficacy of conventional and CAD CAM mandibular advancement device.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: January 10, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

Inclusion Criteria:

• Apnea Hypopnea Index score from 5 to 30 events per hour of sleep

• 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:

• Patients with primarily central sleep apnea (central sleep apnea events more than 2 or 3 per hour)

• 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

Related Conditions & MeSH terms

• Apnea

Intervention

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
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

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Alexandria University, Egypt	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Nourhan M.Aly

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Oxygen saturation	This will be measured using an oximeter. A normal level of oxygen is usually 95% or higher.	4 months
Primary	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