UnknownNot Applicable

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

Denmark69 participantsStarted 2020-04-01

Plain-language 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.

Who can participate

Age range

9 Years – 14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Presence and grade of obstructive sleep apnea

Timeframe: Baseline

Presence and grade of obstructive sleep apnea

Timeframe: 4-8 months from baseline (after expansion plate)

Presence and grade of obstructive sleep apnea

Timeframe: 14-18 months from baseline (after z-activator (MAD))

Oxygen desaturation index (ODI)

Timeframe: Baseline

Oxygen desaturation index (ODI)

Timeframe: 4-8 months from baseline (after expansion plate)

Oxygen desaturation index (ODI)

Timeframe: 14-18 months from baseline (after z-activator (MAD))

Snore Index

Timeframe: Baseline

Trial details

NCT IDNCT04964830

SponsorUniversity of Copenhagen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-01

View on ClinicalTrials.gov More Overjet, Dental trials

Plain-language summary

Who can participate

Age range

9 Years – 14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Presence and grade of obstructive sleep apnea

Timeframe: Baseline

Presence and grade of obstructive sleep apnea

Timeframe: 4-8 months from baseline (after expansion plate)

Presence and grade of obstructive sleep apnea

Timeframe: 14-18 months from baseline (after z-activator (MAD))

Oxygen desaturation index (ODI)

Timeframe: Baseline

Oxygen desaturation index (ODI)

Timeframe: 4-8 months from baseline (after expansion plate)

Oxygen desaturation index (ODI)

Timeframe: 14-18 months from baseline (after z-activator (MAD))

Snore Index

Timeframe: Baseline