Status:
COMPLETED
Assessment of the Efficacy of the Aerodentis System
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Orthodontic Treatment
Tooth Crowding
Eligibility:
All Genders
12-60 years
Phase:
NA
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...
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 attach...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 21 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2020
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT03421886
Start Date
July 21 2016
End Date
June 30 2020
Last Update
November 4 2020
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294