Examining the effects of premolar extractions on sleep apnea in children with overjet
The Effect of Upper Premolars Extraction on Obstructive Sleep Apnea in Growing Children with Prominent Upper Front Teeth
This study is testing whether removing upper premolars can improve sleep apnea in children aged 10-15 who have both sleep apnea and a large overjet.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 10 Years to 15 Years |
| Sex | All |
| Sponsor | University of Kentucky Academic / other |
| Locations | 1 site (Lexington, Kentucky) |
| Trial ID | NCT04946201 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the impact of upper premolar extractions on the Apnea Hypopnea Index (AHI) in pediatric patients diagnosed with obstructive sleep apnea and excessive overjet. Participants aged 10-15 years will undergo polysomnography before and after orthodontic treatment to compare outcomes with similar patients who do not receive extractions. The study focuses on children who are registered orthodontic patients and meet specific inclusion criteria, ensuring a controlled environment for evaluating the effects of the intervention.
Who should consider this trial
Good fit: Ideal candidates are children aged 10-15 years with a diagnosis of Class II Division I malocclusion and excessive overjet who are registered orthodontic patients.
Not a fit: Patients with known hypercapnia, hypoventilation, or significant airway obstructions such as hypertrophic tonsils and adenoids may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into effective orthodontic treatments for improving sleep apnea symptoms in children.
How similar studies have performed: While there is limited data on this specific approach, similar studies have explored orthodontic interventions for sleep apnea, indicating potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 10-15 years old * registered orthodontic patients * able to undergo routine orthodontic care and are registered to obtain an orthodontic appliance in the future. * do not have a high care need * no known hypercapnia or hypoventilation * no known allergies or nose blockages * diagnosed as Class II Division I (=6mm of overjet) and bilateral Class II half cusp or unilateral Class II full cusp. Exclusion Criteria: * known hypercapnia or hypoventilation * patients with hypertrophic tonsils and adenoids * patients with allergies or nose blockages that interfere with breathing * patients who are not registered as orthodontic patients at research sites deemed acceptable to undergo routine orthodontic care
Where this trial is running
Lexington, Kentucky
- University of Kentucky — Lexington, Kentucky, United States (Recruiting)
Study contacts
- Study coordinator: Mohamed Bazina, DDS, MSD
- Email: mba375@uky.edu
- Phone: 18593234139
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.