Obstructive Sleep ApneaNCT04946201
Premolar Extractions for Obstructive Sleep Apnea in Children With Overjet
An observational study of Obstructive Sleep Apnea and Malocclusion, run by Mohamed Bazina at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea, Malocclusion
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2021to Dec 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Registered orthodontic patients at the College of Dentistry and Turfland Dental Clinics.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Obstructive Sleep Apnea, Malocclusion
- Keywords
- orthodontic, braces, extraction, teeth, overjet
- Medical subject headings
- Sleep Apnea, Obstructive, Malocclusion, Overbite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| With Extractions | Patients in this group will undergo dental extractions. | |
| Without Extractions | Patients in this group will not undergo dental extractions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of Obstructive Sleep Apnea
Percentage of participants who develop obstructive sleep apnea following orthodontic treatment.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start2 Sep 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Why it stopped: Reduction in staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohamed Bazina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Bazina, University of Kentucky
- Investigators
- Mohamed Bazina, DDS, MSD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04946201
- Sponsor's protocol ID
- 63668
- Status last verified
- Dec 2025
- First submitted
- 22 Jun 2021
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Upper Premolars Extraction on Obstructive Sleep Apnea in Growing Children With Prominent Upper Front Teeth
- ClinicalTrials.gov ID
- NCT04946201
- Acronym / sponsor ID
- 63668
- Conditions
- Obstructive Sleep Apnea, Malocclusion
- Keywords
- orthodontic, braces, extraction, teeth, overjet
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Reduction in staff
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mohamed BazinaUniversity, hospital or other
- Study start
- 2 Sep 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With Extractions | – | –Patients in this group will undergo dental extractions. |
| Without Extractions | – | –Patients in this group will not undergo dental extractions. |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Registered orthodontic patients at the College of Dentistry and Turfland Dental Clinics.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Risk of Obstructive Sleep Apnea
Time frame: 30 months
Percentage of participants who develop obstructive sleep apnea following orthodontic treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Bazina, DDS, MSD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea and Malocclusion, run by Mohamed Bazina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk of Obstructive Sleep Apnea (time frame: 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.