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SuspendedNCT04946201Updated Dec 24, 2025

Premolar Extractions for Obstructive Sleep Apnea in Children With Overjet

An observational study in Obstructive Sleep Apnea and Malocclusion, sponsored by Mohamed Bazina. Suspended at 1 site in United States. Open to participants aged 10 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-24.

Sponsored by Mohamed Bazina · Observational

Why this study was suspended
Reduction in staff
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
60
Ages
10 Years to 15 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Obstructive Sleep Apnea
  • Malocclusion

Keywords

  • orthodontic
  • braces
  • extraction
  • teeth
  • overjet
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In context

Sleep Apnea, Obstructive

2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.

This study's planned enrollment of 60 is below the median of 105 across 666 observational studies indexed under Sleep Apnea, Obstructive.

Browse Sleep Apnea, Obstructive studies →

Lead sponsor

Mohamed Bazina is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • With Extractions

    Patients in this group will undergo dental extractions.

  • Without Extractions

    Patients in this group will not undergo dental extractions.

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What researchers measure

Primary outcomes

  1. Risk of Obstructive Sleep Apnea

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

    Time frame: 30 months

07

Study locations

1 site
  • University of Kentucky
    Lexington, Kentucky 40506, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2021 (actual). Primary completion is estimated for Dec 2026, 63 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 22, 2021
First posted
Jun 30, 2021
StartActual
Sep 2, 2021
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2026
Last update
Dec 24, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04946201
Lead sponsor
Mohamed Bazina
Responsible party
Mohamed Bazina (Assistant Professor, University of Kentucky) — Sponsor-investigator
First posted
Jun 30, 2021
Start date
Sep 2, 2021
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Dec 24, 2025

Study contacts

Mohamed Bazina, DDS, MSD
principal investigator · University of Kentucky

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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