Assessment of the Efficacy of the Aerodentis System
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Dental |
| Therapuetic Areas: | Dental / Maxillofacial Surgery |
| Healthy: | No |
| Age Range: | 12 - 60 |
| Updated: | 9/2/2018 |
| Start Date: | July 21, 2016 |
| End Date: | December 30, 2019 |
Assessment of the Efficacy of Orthodontic Tooth Movement Using the Aerodentis System
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.
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.
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.
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.
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.
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