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Assessment of the Efficacy of the Aerodentis System

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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

Tracking Information
First Submitted Date  ICMJE January 12, 2018
First Posted Date  ICMJE February 5, 2018
Results First Submitted Date  ICMJE August 10, 2020
Results First Posted Date  ICMJE November 4, 2020
Last Update Posted Date November 4, 2020
Actual Study Start Date  ICMJE July 21, 2016
Actual Primary Completion Date July 21, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2020)
Litter's Index (Change in Little's Index Mean Total Score From Baseline) [ 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. ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 29, 2018)
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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of the Efficacy of the Aerodentis System
Official Title  ICMJE Assessment of the Efficacy of Orthodontic Tooth Movement Using the Aerodentis System
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Orthodontic Treatment
  • Tooth Crowding
  • Orthodontics
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Aerodentis system
    30 patients will be systematically assigned to the treatment group (wearing Aerodentis Device).
    Intervention: Device: Aerodentis system
  • Active Comparator: Invisalign clear aligner system
    15 patients will be systematically assigned to the control group (wearing clear aligners).
    Intervention: Device: Invisalign clear aligner system
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 29, 2018)
45
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 30, 2020
Actual Primary Completion Date July 21, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 60 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03421886
Other Study ID Numbers  ICMJE 160418007
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chung How Kau, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chung How Kau, BDS, PhD University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP