Trials
Search / Trial NCT05661747

Dental Appliance to Treat SDB in Children

Launched by VIVOS BIOTECHNOLOGIES, INC. · Dec 14, 2022

Trial Information

Current as of January 21, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying whether a special mouthguard, which is already available on the market, can help reduce symptoms of sleep-disordered breathing (SDB) in children. SDB includes issues like snoring and obstructive sleep apnea, which can affect a child’s sleep quality and overall health. The researchers want to see if this dental appliance can improve these conditions for kids who are also planning to get orthodontic treatment.

To participate in the trial, children must be between 6 and 18 years old and have a diagnosis of sleep-disordered breathing. They must also have permanent or mixed teeth. However, some children may not be eligible if they have poor oral hygiene, uncontrolled diabetes, severe sleep apnea, or certain other medical conditions. Those who join the study can expect to use the mouthguard and be monitored for any improvements in their sleep-related symptoms. This trial is currently recruiting participants across the United States, and parents will need to provide consent for their child to take part.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Over the age of 6 and under the age of 18 years
  • Permanent dentition or mixed dentition at time of evaluation
  • Diagnosis of sleep-disordered breathing (including snoring, upper airway resistance syndrome, and/or mild to moderate obstructive sleep apnea)
  • Have chosen to have orthodontic treatment
  • Living in the United States
  • Signed Informed Consent Form
  • Exclusion Criteria:
  • Poor oral hygiene
  • Uncontrolled diabetes
  • Severe obstructive sleep apnea (AHI\> 10/hr)
  • Enlarged tonsils of a Grade 4 (\>75% of space between pillars)
  • Diagnosed with a Temporomandibular join condition (TMJ)
  • Any severe breathing or respiratory disorder, such as chronic asthma, emphysema, COPD, or a similar condition
  • Orthodontic braces in situ

Trial Officials

Mark Musso, DDS

Principal Investigator

Musso Family Dentistry

About Vivos Biotechnologies, Inc.

Vivos Biotechnologies, Inc. is a pioneering biotechnology company focused on developing innovative therapeutic solutions for a range of medical conditions. With a commitment to advancing patient care through cutting-edge research and technology, Vivos harnesses the power of biotechnology to create products that aim to improve health outcomes and enhance quality of life. The company is dedicated to conducting rigorous clinical trials that adhere to the highest standards of scientific integrity and regulatory compliance, ensuring that their therapies are both safe and effective. Through collaboration with leading experts and institutions, Vivos Biotechnologies strives to push the boundaries of medical science and deliver transformative treatments to patients in need.

Locations

Colorado Springs, Colorado, United States

Panama City Beach, Florida, United States

Garland, Texas, United States

League City, Texas, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

Similar Trials