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Bibloc Mandibular Advancement Oral Device and Its Effect on TMJ Health

NCT06492096 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2024-07-09

No results posted yet for this study

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

DEVICE

Bibloc Mandibular Advancement device

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

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-15
Primary Completion
2024-04-23
Completion
2024-05-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06492096 on ClinicalTrials.gov