Status:

COMPLETED

Bibloc Mandibular Advancement Oral Device and Its Effect on TMJ Health

Lead Sponsor:

Mansoura University

Conditions:

Obstructive Sleep Apnea of Adult

Eligibility:

All Genders

30-50 years

Phase:

NA

Brief Summary

The goal of this clinical trial is to learn if Mandibular Advancement Device( MAD) works to treat Obstructive sleep apnea in adults. It will also learn about the effect of the device on the Tempromand...

Eligibility Criteria

Inclusion

  • \- Patients having obstructive sleep apnea syndrome (OSAS) as determined by polysomnography with mild to moderate apnea/hypopnea index ranging from 5 to 30 events per hour of sleep. ( As 5-15 events per hour is considered mild condition, 16-30 is considered moderate).(1)
  • 2- Adequate nasal air flow capacity as determined by qualified otolaryngologist.

Exclusion

  • patients having Central sleep apnea events as determined by the polysomnography.
  • 2- patients having cardiovascular disease. 3- History of alcohol, narcotic or psychoactive medications. 4- Serious nasal passage obstructions or allergies. 5- Previous history of treatment with any type of obstructive sleep apnea oral appliances.
  • 6- Obese patients with BMI more than 30. 7- Missing more than five teeth (excluding third molar). 8- Allergy to acrylic resin.

Key Trial Info

Start Date :

June 15 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 30 2024

Estimated Enrollment :

66 Patients enrolled

Trial Details

Trial ID

NCT06492096

Start Date

June 15 2022

End Date

May 30 2024

Last Update

July 9 2024

Active Locations (1)

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1

Faculty of dentistry, Mansoura university

Al Manşūrah, Ad Dakahlia, Egypt, 35511