Premolar Extractions for Obstructive Sleep Apnea in Children With Overjet

NCT ID: NCT04946201

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-02

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Malocclusion Obstructive Sleep Apnea

Keywords

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orthodontic braces extraction teeth overjet

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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With Extractions

Patients in this group will undergo dental extractions.

No interventions assigned to this group

Without Extractions

Patients in this group will not undergo dental extractions.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mohamed Bazina

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Bazina

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mohamed Bazina, DDS, MSD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

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University of Kentucky

Lexington, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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63668

Identifier Type: -

Identifier Source: org_study_id