Premolar Extractions for Obstructive Sleep Apnea in Children With Overjet

Obstructive Sleep Apnea Clinical Trial

Official title:

The Effect of Upper Premolars Extraction on Obstructive Sleep Apnea in Growing Children With Prominent Upper Front Teeth

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04946201
• Other study ID #: 63668
• Status: Recruiting
• Start date: September 2, 2021
• Est. completion date: December 10, 2024

Study information

• Verified date: February 2024
• Source: University of Kentucky
• Contact: Mohamed Bazina, DDS, MSD
• Phone: 18593234139
• Email: mba375[@]uky.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This research aims to provide pediatric patients with polysomnography (a sleep study) before and after orthodontic treatment to determine if the extraction of upper premolars for treating excessive overjet results in an increase of the AHI (Apnea Hypopnea Index) compared to similar patients treated without upper premolar extractions.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 10, 2024
• Est. primary completion date: December 10, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Malocclusion
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Mohamed Bazina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk of Obstructive Sleep Apnea	Percentage of participants who develop obstructive sleep apnea following orthodontic treatment.	30 months