Premolar Extractions for Obstructive Sleep Apnea in Children With Overjet

NCT04946201 | Suspended

• 1 other identifier: 63668
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obstructive Sleep Apnea; Malocclusion

Keywords

orthodontic; braces; extraction; teeth; overjet

Outcome Measures

Primary Outcomes (1)

• Risk of Obstructive Sleep Apnea

  Percentage of participants who develop obstructive sleep apnea following orthodontic treatment.

  30 months

Study Arms (2)

With Extractions

Patients in this group will undergo dental extractions.

Without Extractions

Patients in this group will not undergo dental extractions.

Eligibility Criteria

• Age: 10 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mohamed Bazina: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Malocclusion; Overbite

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Tooth Diseases; Stomatognathic Diseases; Malocclusion, Angle Class II

Study Officials

• Mohamed Bazina, DDS, MSD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: June 30, 2021
• Study Start: September 2, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)