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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: Completed NA study, sponsored by University of Alabama at Birmingham.
NCT03421886 is a NA study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 45 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Litter's Index of Displacement score is the primary clinical endpoint used to judge patient success. Tooth alignment is assessed by Litter's Index of Displacement. It is performed at the five contact points for the teeth located in lower 1's through 3's. This index is the sum of the numbers recorded at each of the 5 points which are in millimeters. Subjects were followed for a total of up to 15 months or until achieving a Little's index of \<1.5, whichever came first. The Litter's Index was
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 |
What the finished NCT03421886 record still lists
NCT03421886 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Aerodentis system is the first listed.
NCT03421886 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03421886's enrollment target sits among peer trials
45 1411th of 2000 higher than 578 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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