NCT06492096

Bibloc Mandibular Advancement Oral Device and Its Effect on TMJ Health

Relation Between Bibloc Mandibular Advancement Oral Appliance Used In Treatment of Obstructive Sleep Apnea and Tempromandibular Joint Health

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 30 Years – 50 Years
• Healthy volunteers: Not accepted

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 Tempromandibular Joint Health . The main questions it aims to answer are: Does MAD lower the number of apnoea and hypopnea participants suffer from during sleep? Would it cause any effect on TMJ health? Researchers will compare between a group of TMD patients with OSA to a non\_TMD group of patients also with sleep apnea and both groups will receive a Bibloc MADplacebo (a look-alike substance that contains no drug) to see if it affect the TMJ health. Participants will: Wear MAD during sleep (at least 6 hours) every day for 6 months Visit the clinic once after the first week for checkups and adjustment of MAD If needed and then after 3 months and 6 months. Polysomnography, MRI, and tmd screening was done before the appliance insertion and after 6 months of its insertion.

Conditions

• Obstructive Sleep Apnea of Adult

Interventions

Type	Name	Description
DEVICE	Bibloc Mandibular Advancement device	Each patient received a CAD/CAM designed Bibloc Mandibular Advancement device

Timeline

• Start date: 2022-06-15
• Primary completion: 2024-04-23
• Completion: 2024-05-30
• First posted: 2024-07-09
• Last updated: 2024-07-09

Locations

1 site across 1 country: Egypt