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Clinical Trials/NCT04946201
NCT04946201
Suspended
Not Applicable

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

Mohamed Bazina1 site in 1 country60 target enrollmentSeptember 2, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obstructive Sleep Apnea
Sponsor
Mohamed Bazina
Enrollment
60
Locations
1
Primary Endpoint
Risk of Obstructive Sleep Apnea
Status
Suspended
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2, 2021
End Date
December 1, 2026
Last Updated
4 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Mohamed Bazina
Responsible Party
Sponsor Investigator
Principal Investigator

Mohamed Bazina

Assistant Professor

University of Kentucky

Eligibility Criteria

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

Outcomes

Primary Outcomes

Risk of Obstructive Sleep Apnea

Time Frame: 30 months

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

Study Sites (1)

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