Clinical Trials Directory

Trials / Unknown

UnknownNCT04964830

Sleep, Upper Airway and Dental Occlusion in Children With Large Overjet

Sleep, Upper Airway and Dental Occlusion in Children With Large Overjet Before and After Treatment With a Mandibular Advancement Device (MAD)

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
69 (actual)
Sponsor
University of Copenhagen · Academic / Other
Sex
All
Age
9 Years – 14 Years
Healthy volunteers
Accepted

Summary

This project examines sleep (e.g. prevalence of obstructive sleep apnea(OSA)), dimension of upper airway, jaw function, well-being and quality of life in children with large overjet compared to a control group. In addition, the effect of treatment with a mandibular advancement device (MAD) on sleep, upper airway and jaw function are examined, and how these factors affect the children's well-being and quality of life.

Detailed description

Sleep is very important for children's growth, development and learning. The anatomy and size of the airway and position of the jaw can affect children's sleep. Children with large overjet due to a posterior position of the mandible have smaller airways compared to children with neutral occlusion. Reduced dimensions of the upper airways may increase the risk of impaired sleep quality and the sleep related breathing disorder obstructive sleep apnoea (OSA), which causes symptoms e.g. failure to thrive, irritability, behavioural disorders, fatigue, which affects the children's growth, development, and learning negatively. Children with large overjet due to mandibular retrognathia in Denmark are offered orthodontic treatment in municipal dental care and are in most cases treated with a mandibular advancement device (MAD) keeping the mandible in a forward position relative to the maxilla. MADs are also used to treat adults with mild-moderate obstructive sleep apnoea while they sleep. This can reduce the number of apnoea periods by up to 75% as well as preventing daytime sleepiness. No previous study have examined sleep, upper airway, jaw function, well-being and quality of life in children with large overjet before, during and after MAD treatment compared to a control group with normal occlusion.

Conditions

Interventions

TypeNameDescription
DEVICEOrthodontic treatment with functional appliance (MAD)Expansion plate and z-activator (MAD)

Timeline

Start date
2020-04-01
Primary completion
2024-09-01
Completion
2025-12-31
First posted
2021-07-16
Last updated
2024-03-15

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT04964830. Inclusion in this directory is not an endorsement.