Assessment of the Efficacy of the Aerodentis System

NCT03421886 | Completed Results FDA Device

• 1 other identifier: 160418007
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Litter's Index (Change in Little's Index Mean Total Score From Baseline)

  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.

  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.

Study Arms (2)

Aerodentis system

EXPERIMENTAL

30 patients will be systematically assigned to the treatment group (wearing Aerodentis Device).

Device: Aerodentis system

Invisalign clear aligner system

ACTIVE COMPARATOR

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

Device: Invisalign clear aligner system

Interventions

Aerodentis system DEVICE

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.

Aerodentis system

Invisalign clear aligner system DEVICE

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.

Invisalign clear aligner system

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Permanent dentition
• Patients that in the opinion of the investigator will be compliant with device use. Compliance is determined by patient questionnaire.
• Class I malocclusion with crowding of \<6 mm between the anterior teeth from the right first premolar to the left first premolar, on the upper and lower.
• Good oral hygiene, as determined by investigator orthodontist.

You may not qualify if:

• Any medical or dental condition that, in the opinion of the investigator, could negatively affect study results during the expected length of the study. Conditions can include poor oral hygiene, extensive dental treatments, or periodontal disease.
• Patient is currently using any investigational drug or any other investigational device.
• Patient plans to relocate or move during the treatment period.
• Pregnant females. Orthodontic treatment is not advised in pregnant females.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

• Wang J, Lamani E, Christou T, Li P, Kau CH. A randomized trial on the effects of root resorption after orthodontic treatment using pulsating force. BMC Oral Health. 2020 Aug 27;20(1):238. doi: 10.1186/s12903-020-01226-z.

  PMID: 32854693 DERIVED

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Chung How Kau, chair and professor
• Organization: University of Alabama at Birmingham

ckau@uab.edu

(205) 934-2782

Study Officials

• Chung How Kau, BDS, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: February 5, 2018
• Study Start: July 21, 2016
• Primary Completion: July 21, 2019
• Study Completion: June 30, 2020
• Last Updated: November 4, 2020
• Results First Posted: November 4, 2020

Record last verified: 2020-10

Locations

US (1)