Orthodontic TreatmentNCT03421886
Assessment of the Efficacy of the Aerodentis System
A study testing Aerodentis system and Invisalign clear aligner system in people with Orthodontic Treatment and Tooth Crowding, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Treatment, Tooth Crowding, Orthodontics
- What is being tested?
- Aerodentis system and Invisalign clear aligner system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2016to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: 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.
Read the 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.
- Conditions
- Orthodontic Treatment, Tooth Crowding, Orthodontics
- Being tested
- Aerodentis system, Invisalign clear aligner system
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerodentis systemDevice
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.
Invisalign clear aligner systemDevice
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 group | Role | What they receive |
|---|---|---|
| Aerodentis system | Experimental | 30 patients will be systematically assigned to the treatment group (wearing Aerodentis Device). Receives: Device: Aerodentis system |
| Invisalign clear aligner system | Active comparator | 15 patients will be systematically assigned to the control group (wearing clear aligners). Receives: Device: Invisalign clear aligner system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Litter's Index (Change in Little's Index Mean Total Score From Baseline)
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start21 Jul 2016
- Primary completion21 Jul 2019
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orthodontic TreatmentStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chung How Kau, University of Alabama at Birmingham
- Investigators
- Chung How Kau, BDS, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03421886
- Sponsor's protocol ID
- 160418007
- Status last verified
- Oct 2020
- First submitted
- 12 Jan 2018
- Last updated
- 4 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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.
PubMed 32854693
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Efficacy of Orthodontic Tooth Movement Using the Aerodentis System
- ClinicalTrials.gov ID
- NCT03421886
- Acronym / sponsor ID
- 160418007
- Conditions
- Orthodontic Treatment, Tooth Crowding, Orthodontics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 21 Jul 2016 (actual)
- Primary completion
- 21 Jul 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Posted 4 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerodentis system | Experimental | Device: Aerodentis system30 patients will be systematically assigned to the treatment group (wearing Aerodentis Device). |
| Invisalign clear aligner system | Active comparator | Device: Invisalign clear aligner system15 patients will be systematically assigned to the control group (wearing clear aligners). |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerodentis systemThe 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 | Aerodentis system |
| Invisalign clear aligner systemClear 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. | Device | Invisalign clear aligner system |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32854693Wang 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.
Related trials for Orthodontic Treatment
Active, not recruitingObservational study
Accuracy and Time Efficiency of AI Versus Manual Segmentation in Adult Crowding Using Aligner Software
Dental Crowding
Enrolling by invitation
Discision as Acceleration Method in Canine Retraction in Orthodontics With Aligner and Fixed Appliances in Young Adults a Split Mouth Study
Bimaxillary Protrusion, Class II Div 1 Malocclusion
Not yet recruiting
Manus AI-Assisted Orthodontic Education and Oral Health-Related Quality of Life
Oral Health-Related Quality of Life
Active, not recruiting
A Split-Mouth Clinical Trial Evaluating the Bond Failure Rate of a New Etch-Free Orthodontic Adhesive
Bracket Bonding, Orthodontic Treatment
Active, not recruiting
Treatment of the Mandibular Dental Crowding With and Without Corticotomy Surgery
Dental Research, Orthodontics
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chung How Kau, BDS, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerodentis system and Invisalign clear aligner system in people with Orthodontic Treatment and Tooth Crowding, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03421886, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.