Premolar Extractions for Obstructive 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 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.

Study Overview

• Status: Suspended
• Conditions: Obstructive Sleep Apnea; Malocclusion

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • University of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 15 years (Child)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Registered orthodontic patients at the College of Dentistry and Turfland Dental Clinics.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
With Extractions; Patients in this group will undergo dental extractions.
Without Extractions; Patients in this group will not undergo dental extractions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk of Obstructive Sleep Apnea	Percentage of participants who develop obstructive sleep apnea following orthodontic treatment.	30 months

Collaborators and Investigators

• Sponsor: Mohamed Bazina
• Investigators: Principal Investigator: Mohamed Bazina, DDS, MSD, University of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 22, 2021
• First Submitted That Met QC Criteria: June 22, 2021
• First Posted (Actual): June 30, 2021

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: orthodontic; extraction; teeth; overjet; braces
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Nervous System Diseases; Tooth Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Malocclusion, Angle Class II; Malocclusion; Overbite; Sleep Apnea, Obstructive
• Other Study ID Numbers: 63668

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No