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NCT04946201 Clinical Trial

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
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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