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Assessment of the Efficacy of the Aerodentis System

NCT03421886 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2020-11-04

Study results available
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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.

Conditions

  • Orthodontic Treatment
  • Tooth Crowding
  • Orthodontics

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.

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Chung How Kau, BDS, PhD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-07-21
Primary Completion
2019-07-21
Completion
2020-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03421886 on ClinicalTrials.gov