Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Assessment of the Efficacy of the Aerodentis System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03421886
Recruitment Status : Completed
First Posted : February 5, 2018
Results First Posted : November 4, 2020
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
Chung How Kau, University of Alabama at Birmingham

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions Orthodontic Treatment
Tooth Crowding
Orthodontics
Interventions Device: Aerodentis system
Device: Invisalign clear aligner system
Enrollment 45
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aerodentis System Invisalign Clear Aligner System
Hide Arm/Group Description

30 patients was systematically assigned to the treatment group (wearing Aerodentis 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.

15 patients was systematically assigned to the control group (wearing clear aligners).

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.

Period Title: Overall Study
Started 30 15
Completed 23 13
Not Completed 7 2
Arm/Group Title Aerodentis System Invisalign Clear Aligner System Total
Hide Arm/Group Description

28 patients was systematically assigned to the treatment group (wearing Aerodentis Device) due to 2 run-in fails.

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.

15 patients was systematically assigned to the control group (wearing clear aligners).

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.

Total of all reporting groups
Overall Number of Baseline Participants 30 15 45
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 15 participants 45 participants
30.6  (12) 32.3  (16.4) 31  (14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 15 participants 45 participants
Female
25
  83.3%
10
  66.7%
35
  77.8%
Male
5
  16.7%
5
  33.3%
10
  22.2%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants 15 participants 45 participants
30 15 45
1.Primary Outcome
Title Litter's Index (Change in Little's Index Mean Total Score From Baseline)
Hide Description

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 Baseline Little's Index with statistical analysis between investigational and control groups, and the Final Little's Index between investigational and control groups. Comparison of change in Little's Index from baseline to final was also done between investigational and control groups.

A negative change in from baseline to the end-point represent a decrease in the degree of anterior irregularity.

Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aerodentis System Invisalign Clear Aligner System
Hide Arm/Group Description:

30 patients was systematically assigned to the treatment group (wearing Aerodentis 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.

15 patients was systematically assigned to the control group (wearing clear aligners).

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.

Overall Number of Participants Analyzed 23 13
Mean (Standard Deviation)
Unit of Measure: mm
Baseline Little's Index 5.7  (2.3) 6.2  (2.9)
Endpoint Little's Index 0.6  (0.5) 0.3  (0.3)
Change of Little's Index -3.9  (2.8) -4.7  (2.8)
Time Frame 55 weeks (13.75 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aerodentis System Invisalign Clear Aligner System
Hide Arm/Group Description

30 patients was systematically assigned to the treatment group (wearing Aerodentis 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.

15 patients was systematically assigned to the control group (wearing clear aligners).

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.

All-Cause Mortality
Aerodentis System Invisalign Clear Aligner System
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/15 (0.00%) 
Hide Serious Adverse Events
Aerodentis System Invisalign Clear Aligner System
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/15 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Aerodentis System Invisalign Clear Aligner System
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/15 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chung How Kau, chair and professor
Organization: University of Alabama at Birmingham
Phone: (205) 934-2782
EMail: ckau@uab.edu
Layout table for additonal information
Responsible Party: Chung How Kau, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03421886    
Other Study ID Numbers: 160418007
First Submitted: January 12, 2018
First Posted: February 5, 2018
Results First Submitted: August 10, 2020
Results First Posted: November 4, 2020
Last Update Posted: November 4, 2020