Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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.

View on ClinicalTrials.gov ↗

View your shortlist →

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

FieldValue
Enrollment Target 45 participants
Start Date 2016-07-21
Est. Completion 2020-06-30
Phase NA

Sponsor

University of Alabama at Birmingham

1,160 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.