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NCT03421886 · ClinicalTrials.gov registry record · NA
Assessment of the Efficacy of the Aerodentis System
A NA study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- NA
- Development phase
- 45
- Enrollment target
NCT03421886 is a NA study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 45 participants.
The verdict
NCT03421886, a NA study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- NA
- Development phase
- 45 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy of the Aerodentis System for orthodontic tooth movement in an open label, two-arms, non-inferiority clinical study. This open-label, two-arm study will follow 45 patients for up to fifteen months. Thirty participants will wear the Aerodentis device, and fifteen participants will wear Invisalign, a commonly used clear appliance. Patients will be assigned to participate in the treatment group using the Aerodentis device at home for 10 hours daily or in the control group using clear correctors for the duration of up to 15 months. Outcome assessments will be performed every 4 weeks. Assessments will include tooth movement and quality of life assessments.
Interventions
- DEVICE Aerodentis system
- DEVICE Invisalign clear aligner system
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2016-07-21 |
| Est. Completion | 2020-06-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03421886
The ClinicalTrials.gov registry entry for NCT03421886 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Aerodentis system is the first listed.
NCT03421886 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03421886 about?
NCT03421886 is a clinical study titled "Assessment of the Efficacy of the Aerodentis System". The purpose of this study is to evaluate the efficacy of the Aerodentis System for orthodontic tooth movement in an open label, two-arms, non-inferiority clinical study. This open-label, two-arm study will follow 45 patients for up to fifteen months. Thirty participants will wear the Aerodentis devi...
What is the current status of trial NCT03421886?
This trial is currently completed. It is a NA study. The enrollment target is 45 participants. The study started on 2016-07-21. Estimated completion is 2020-06-30.
What interventions are being tested in trial NCT03421886?
The interventions under investigation include: Aerodentis system (DEVICE), Invisalign clear aligner system (DEVICE).
Who is sponsoring clinical trial NCT03421886?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
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