NCT03421886

Assessment of the Efficacy of the Aerodentis System

Completed NA Results posted Last updated 4 November 2020

What this trial tests

NA trial testing Aerodentis system in Orthodontic Treatment in 45 participants. Completed in 30 June 2020.

Timeline

21 July 2016

Primary endpoint
21 July 2019

30 June 2020

Quick facts

Lead sponsor	University of Alabama at Birmingham
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	45
Start date	21 July 2016
Primary completion	21 July 2019
Estimated completion	30 June 2020
Sites	1 location across United States

Drugs / interventions tested

• Aerodentis system
• Invisalign clear aligner system

Conditions studied

• Orthodontic Treatment — all drugs for Orthodontic Treatment →
• Tooth Crowding — all drugs for Tooth Crowding →
• Orthodontics — all drugs for Orthodontics →

Sponsor

University of Alabama at Birmingham

Who can join

Adults 12 to 60, any sex, with Orthodontic Treatment or Tooth Crowding. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Litter's Index (Change in Little's Index Mean Total Score From Baseline) Primary · Movement was recorded by capturing the start and end point of the 6 anterior teeth before and at the completion of the treatment respectively. Changes was compared and assessed. The duration of the treatment was an average of 10 months.

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 performed at the baseline and the end-point of the study. Data was analyzed by comparing the Basel

Baseline Little's Index

Group	Value	95% CI
Aerodentis System	5.7	± 2.3
Invisalign Clear Aligner System	6.2	± 2.9

Endpoint Little's Index

Group	Value	95% CI
Aerodentis System	0.6	± 0.5
Invisalign Clear Aligner System	0.3	± 0.3

Change of Little's Index

Group	Value	95% CI
Aerodentis System	-3.9	± 2.8
Invisalign Clear Aligner System	-4.7	± 2.8

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A randomized trial on the effects of root resorption after orthodontic treatment using pulsating force.
   Wang J, Lamani E, Christou T, Li P, et al · · 2020 · cited 6× · PMID 32854693 · DOI 10.1186/s12903-020-01226-z