Assessment of the Efficacy of the Aerodentis System

NACompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

July 21, 2016

Primary Completion Date

July 21, 2019

Study Completion Date

June 30, 2020

Conditions
Orthodontic TreatmentTooth CrowdingOrthodontics
Interventions
DEVICE

Aerodentis system

The Aerodentis system is intended for the treatment of tooth malocclusion and is treated by applying force, over time, to teeth requiring alignment. It is an individually-fitted, plastic dental mouthpiece that is inserted and worn by the patient according to the dental practitioner's treatment plan. The Aerodentis system is comprised of a plastic mouthpiece containing an inflatable balloon that provides pressure (force) on the selected teeth designated to be moved to a final treated state. The inflatable balloon is inflated to the desired pressure using an electrical air pump unit that is programmed by the dental practitioner using Dror Orthodesign proprietary software; thus creating a course treatment specially designed for each patient.

DEVICE

Invisalign clear aligner system

Clear aligners are used for the treatment of tooth malocclusion. In these devices, a series of mouthpieces are used, where the force created by each mouthpiece on the treated teeth is designed to push the teeth in small, one step increments, toward the desired result.

Trial Locations (1)

35294

University of Alabama at Birmingham, Birmingham

All Listed Sponsors
lead

University of Alabama at Birmingham

OTHER

NCT03421886 - Assessment of the Efficacy of the Aerodentis System | Biotech Hunter | Biotech Hunter