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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 : Active, not recruiting
First Posted : February 5, 2018
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Chung How Kau, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Orthodontic Treatment Tooth Crowding Orthodontics Device: Aerodentis system Device: Invisalign clear aligner system Not Applicable

Detailed Description:

The Aerodentis system is intended for the treatment of tooth malocclusion and is treated by applying force, over time, to teeth requiring alignment. Traditionally, the force has been created by attaching brackets to the teeth and creating tension through the stretching of flexible wire connected between the brackets. Alternatively, 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.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.

A participant is required to wear the Aerodentis device or conventional clear correctors. Initial photos of participants will be reviewed to establish a pool of eligible potential participants. Then participants will be randomly selected for one of the two groups. Those wearing the Aerodentis device will be asked to answer a quality of life questionnaire. Follow-up assessments will be conducted every 4 weeks for both Aerodentis participants and clear corrector participants. During these assessment's we will look at movement of teeth, any side effects or discomfort the individual may be facing, patient assessment of whether the Aerodentis device is used regularly. Both intraoral and extraoral photos will be taken of patients, during certain time points of the study, as requested by PI or sponsor. If a participant enters and completes the entire study, then that individual will be in the study for up to 15 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Assessment of the Efficacy of Orthodontic Tooth Movement Using the Aerodentis System
Actual Study Start Date : July 21, 2016
Actual Primary Completion Date : July 21, 2019
Estimated Study Completion Date : June 30, 2020

Arm Intervention/treatment
Experimental: Aerodentis system
30 patients will be systematically assigned to the treatment group (wearing Aerodentis Device).
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.

Active Comparator: Invisalign clear aligner system
15 patients will be systematically assigned to the control group (wearing clear aligners).
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.




Primary Outcome Measures :
  1. Litter's Index [ Time Frame: Movement will be recorded by capturing the start and end point of the 6 anterior teeth before and at the completion of the treatment respectively. Changes will be compared and assessed. The duration of the treatment will be an average of 10 months. ]
    The Litter's Index of Displacement score will be the primary clinical endpoint used to judge patient success. Tooth movement and alignment will be assessed by Litter's Index of Displacement. The Litter's Index will be performed at baseline and each subsequent visit, and will be performed at the five contact points for the teeth located in lower 1's through 3's. This index will be recorded in millimeters for each of the 5 points.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03421886


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Chung How Kau, BDS, PhD University of Alabama at Birmingham
  Study Documents (Full-Text)

Documents provided by Chung How Kau, University of Alabama at Birmingham:
Statistical Analysis Plan  [PDF] September 27, 2016
Study Protocol  [PDF] July 14, 2016
Informed Consent Form  [PDF] October 6, 2016

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chung How Kau, Professor and Chair, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03421886    
Other Study ID Numbers: 160418007
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Malocclusion
Tooth Diseases
Stomatognathic Diseases