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
1 other identifier
interventional
66
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 23, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2024
CompletedFirst Submitted
Initial submission to the registry
July 1, 2024
CompletedFirst Posted
Study publicly available on registry
July 9, 2024
CompletedJuly 9, 2024
April 1, 2022
1.9 years
July 1, 2024
July 1, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Apnea/Hypopnea index
Number of apnea and hypopnea per hour of sleep
6 months
Secondary Outcomes (2)
Condylar disc position
6 months
Joint space of TMJ
6 months
Study Arms (2)
TMD Group
ACTIVE COMPARATORNon_TMD Group
ACTIVE COMPARATORInterventions
Each patient received a CAD/CAM designed Bibloc Mandibular Advancement device
Eligibility Criteria
You may qualify if:
- \- 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)
- Adequate nasal air flow capacity as determined by qualified otolaryngologist.
You may not qualify if:
- patients having Central sleep apnea events as determined by the polysomnography.
- 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.
- Obese patients with BMI more than 30. 7- Missing more than five teeth (excluding third molar). 8- Allergy to acrylic resin.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of dentistry, Mansoura university
Al Manşūrah, Ad Dakahlia, 35511, Egypt
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2024
First Posted
July 9, 2024
Study Start
June 15, 2022
Primary Completion
April 23, 2024
Study Completion
May 30, 2024
Last Updated
July 9, 2024
Record last verified: 2022-04