N/A
N=45
Assessment of the Efficacy of the Aerodentis System
Orthodontic Treatment · Tooth Crowding · Orthodontics
Bottom Line
View on ClinicalTrials.gov: NCT03421886 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Litter's Index (Change in Little's Index Mean Total Score From Baseline) — 5.7; 6.2; 0.6; 0.3 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Aerodentis system (Device); Invisalign clear aligner system (Device)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Litter's Index (Change in Little's Index Mean Total Score From Baseline) |
5.7; 6.2; 0.6; 0.3; -3.9; -4.7 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03421886). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.