Ignite Creation Date:
2024-07-17 @ 11:03 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06492096
Status:
COMPLETED
Last Update Posted:
2024-07-09
First Post:
2024-07-01
Brief Title:
Bibloc Mandibular Advancement Oral Device and Its Effect on TMJ Health
Sponsor:
Mansoura University
Organization:
Mansoura University
Study Overview
Official Title:
Relation Between Bibloc Mandibular Advancement Oral Appliance Used In Treatment of Obstructive Sleep Apnea and Tempromandibular Joint Health
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None