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NCT02868554 · ClinicalTrials.gov registry record · NA
Accelerated Invisalign Therapy in Conjunction With Acceledent Aura
A NA study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 34
- Enrollment target
NCT02868554: Completed NA study, sponsored by University of North Carolina, Chapel Hill.
NCT02868554 is a NA study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 34 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02868554, a NA study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 34 participants
- Enrollment target
Study Summary
Purpose: The objective of this study is to investigate the effects of accelerated Invisalign and vibration therapy on rate of orthodontic tooth movement, activation of inflammation biomarkers as well as pain levels experienced by orthodontic patients during the initial 12 weeks of alignment. Participants: Up to 30 orthodontic patients of the University of North Carolina Orthodontic Residency Program will be recruited for this study. Patients older than 18 years old will be otherwise healthy subjects previously diagnosed with malocclusion. Procedures (methods): Each patient will be randomly allocated into either a control group or one of two intervention groups. Patients within the control group will receive standard Invisalign therapy without vibration. Patients within the intervention groups will receive accelerated Invisalign therapy with or without vibration. Patients receiving vibration therapy will utilize an AcceleDent Aura device which provides a light vibration at .25 Newtons (N) and 30 Hertz (Hz) frequency for twenty minutes daily. Three dimensional images of each subject's dentition will be recorded five times at 0 days, 4 days, 2 weeks, 6 weeks, and 12 weeks progress visits.
Primary Outcome
Little's Irregularity Index is the sum of contact displacement in mm between the anterior teeth from mesial of one canine to the mesial of the contralateral canine.
Interventions
- DEVICE AcceleDent Aura
- DEVICE Accelerated Invisalign therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2016-08 |
| Est. Completion | 2019-04-26 |
| Phase | NA |
What the finished NCT02868554 record still lists
NCT02868554 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which AcceleDent Aura is the first listed.
NCT02868554 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02868554 about?
NCT02868554 is a clinical study titled "Accelerated Invisalign Therapy in Conjunction With Acceledent Aura". Purpose: The objective of this study is to investigate the effects of accelerated Invisalign and vibration therapy on rate of orthodontic tooth movement, activation of inflammation biomarkers as well as pain levels experienced by orthodontic patients during the initial 12 weeks of alignment. Parti...
What is the current status of trial NCT02868554?
This trial is currently completed. It is a NA study. The enrollment target is 34 participants. The study started on 2016-08. Estimated completion is 2019-04-26.
What interventions are being tested in trial NCT02868554?
The interventions under investigation include: AcceleDent Aura (DEVICE), Accelerated Invisalign therapy (DEVICE).
Who is sponsoring clinical trial NCT02868554?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02868554's enrollment target sits among peer trials
34 1570th of 2000 higher than 427 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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