Assessment of the Efficacy of the Aerodentis System
Completed · Not applicable
Conditions studied: Orthodontic Treatment, Tooth Crowding, Orthodontics
In brief
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.
Key facts
- Study ID
- NCT03421886
- Run by
- University of Alabama at Birmingham
- People needed
- 45
- Starts
- 2016-07-21
- Expected to finish
- 2020-06-30
- Last updated by the study team
- 2020-11-04
Who can join
Age: 12 and older, up to 60. Sex: any. Healthy volunteers: accepted.
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.
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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