Trial Outcomes & Findings for Assessment of the Efficacy of the Aerodentis System (NCT NCT03421886)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

45 participants

Primary outcome timeframe

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.

Results posted on

2020-11-04

Participant Flow

Participant milestones

Participant milestones
Measure	Aerodentis System 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.	Invisalign Clear Aligner System 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 Study STARTED	30	15
Overall Study COMPLETED	23	13
Overall Study NOT COMPLETED	7	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aerodentis System n=30 Participants 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.	Invisalign Clear Aligner System n=15 Participants 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 n=45 Participants Total of all reporting groups
Age, Continuous	30.6 years STANDARD_DEVIATION 12 • n=30 Participants	32.3 years STANDARD_DEVIATION 16.4 • n=15 Participants	31 years STANDARD_DEVIATION 14 • n=45 Participants
Sex: Female, Male Female	25 Participants n=30 Participants	10 Participants n=15 Participants	35 Participants n=45 Participants
Sex: Female, Male Male	5 Participants n=30 Participants	5 Participants n=15 Participants	10 Participants n=45 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	30 participants n=30 Participants	15 participants n=15 Participants	45 participants n=45 Participants

PRIMARY outcome

Timeframe: 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 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.

Outcome measures

Outcome measures
Measure	Aerodentis System n=23 Participants 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.	Invisalign Clear Aligner System n=13 Participants 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.
Litter's Index (Change in Little's Index Mean Total Score From Baseline) Baseline Little's Index	5.7 mm Standard Deviation 2.3	6.2 mm Standard Deviation 2.9
Litter's Index (Change in Little's Index Mean Total Score From Baseline) Endpoint Little's Index	0.6 mm Standard Deviation 0.5	0.3 mm Standard Deviation 0.3
Litter's Index (Change in Little's Index Mean Total Score From Baseline) Change of Little's Index	-3.9 mm Standard Deviation 2.8	-4.7 mm Standard Deviation 2.8

Adverse Events

Aerodentis System

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Invisalign Clear Aligner System

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Chung How Kau, chair and professor

University of Alabama at Birmingham

Phone: (205) 934-2782

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place