ClinicalTrials.Veeva

Menu

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

University of Copenhagen logo

University of Copenhagen

Status

Active, not recruiting

Conditions

Overjet, Dental

Treatments

Device: Orthodontic treatment with functional appliance (MAD)

Study type

Interventional

Funder types

Other

Identifiers

NCT04964830
H-17011521

Details and patient eligibility

About

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.

Full 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.

Enrollment

69 patients

Sex

All

Ages

9 to 14 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Overjet group:

  • Horizontal maxillary overjet ≥ 6 mm and need of orthodontic treatment according to the Danish procedure for screening the child population for malocclusion involving health risk.
  • Informed consent from parent(s)/guardian(s)

Control group:

  • Neutral occlusion
  • No history of orthodontic treatment
  • Informed consent from parent(s)/guardian(s)

Exclusion criteria

  • Known general and/or craniofacial syndromes/diseases
  • Known sleep disorders, included bruxism during sleep
  • Chronic respiratory diseases and asthma6/12
  • Adenoid vegetations, hypertrophic tonsils and significantly reduces airflow through the nose (mouth breather), which need primary treatment.
  • Dysfunction of masticatory muscles and temporomandibular joint, which need primary treatment.

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

69 participants in 2 patient groups

Children with large overjet
Active Comparator group
Description:
Overjet ≥6 mm, planned orthodontic treatment with functional appliance
Treatment:
Device: Orthodontic treatment with functional appliance (MAD)
Control group
No Intervention group
Description:
Neutral occlusion, no indication for orthodontic treatment, no prior orthodontic treatment

Trial contacts and locations

1

Loading...

Central trial contact

Liselotte Sonnesen, PhD, Professor MSO; Camilla Hansen, DDS, PhD student

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems