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Completed

NCT Number: NCT06492096

Bibloc Mandibular Advancement Oral Device and Its Effect on TMJ Health

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.

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Key information

Conditions

Obstructive Sleep Apnea of Adult

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of dentistry, Mansoura university

Al Manşūrah, Ad Dakahlia, 35511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Bibloc Mandibular Advancement device

Device

Each patient received a CAD/CAM designed Bibloc Mandibular Advancement device

Primary outcomes

  1. Apnea/Hypopnea index

    Time frame: 6 months

    Number of apnea and hypopnea per hour of sleep

Secondary outcomes

  1. Condylar disc position

    Time frame: 6 months

    It appears in MRI and measured before and after the appliance insertion

  2. Joint space of TMJ

    Time frame: 6 months

    measurement of joint space was done for each patient on their MRI before and after the treatment

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 9, 2024
Registry last updated
Jul 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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