CClinicalTrials.gg
CompletedNCT01962012Updated Sep 28, 2016

Effect of AcceleDent® Aura on Orthodontic Tooth Movement With Aligners

A Phase 4 interventional study of AcceleDent Aura and Sham Device in Malocclusion, sponsored by OrthoAccel Technologies Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-28.

Sponsored by OrthoAccel Technologies Inc. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study summary

The purpose of this study is to examine the amount of tooth movement achieved over time between subjects undergoing aligner treatment using a pulsation device known as AcceleDent® Aura with those not using the device.

Read the detailed description

There are many variables that can affect the rate of tooth movement. Preliminary data showed that the rate of tooth movement may be affected by variables such as age, sex, as well as alveolar bone levels, tooth root length and alveolar bone quality. The purpose of this study is to examine the amount of tooth movement achieved over time between subjects undergoing aligner treatment using a pulsation device known as AcceleDent® Aura with those not using the device.

A preliminary validation pilot study will be done to calibrate all staff on study procedures. The pilot will consist of 3 subjects using the active AcceleDent® Aura device and 3 using the sham control AcceleDent® Aura device for 4 weeks. Study staff will be calibrated for all study procedures.

The primary study will be a prospective, single-center, randomized crossover clinical trial comparing two groups of subjects with 40 participants. Subjects will be randomized to groups that will receive aligner treatment while using either an active AcceleDent® Aura device or a sham control AcceleDent® Aura device for the first 6 weeks of the study. After 6 weeks, groups will cross-over and switch devices, and tooth movement will be followed for another 6 weeks. Patients will be blinded as to which device they are using. Amount of tooth movement per week, pain perception, and change in gingival crevicular fluid biomarkers will be outcomes assessed. Device safety evaluation to be performed will include adverse events and clinical examination findings including pulp vitality testing and periodontal probe results.

02

Conditions studied

  • Malocclusion

Browse trials for

Keywords

  • Orthodontic
  • Orthodontic Treatment
  • Accelerated Tooth Movement
  • Malocclusion
  • Device
  • AcceleDent Aura
  • Clear Aligners
03

In context

Malocclusion

457 studies on the registry are indexed under Malocclusion; 89 are open to participants now.

This study's enrollment of 46 is above the median of 36 across 372 interventional studies indexed under Malocclusion.

Browse Malocclusion studies →

Lead sponsor

OrthoAccel Technologies Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Males or females between and including the ages of 18 and 40 yo desiring orthodontic treatment that could be completed within two years of treatment with either fixed appliances or aligner treatment. Subjects may have had previous orthodontic procedures.
  • Adult dentition with all upper front teeth present and any premolar and molar combination in the upper posterior of two teeth on each side.
  • At least one upper maxillary central incisor that is positioned to allow anterio-posterior (AP) movement (crown tipping only) of 1.98 mm.
  • Normal pulp vitality and healthy periodontal tissues as determined by intraoral exam.
  • Good health as determined by medical history.
  • Willingness and ability to comply with study procedures, attend study visits, and complete the study.
  • The ability to understand and sign a written informed consent form, which must be signed prior to initiation of study procedures.

Exclusion criteria

Exclusion Criteria:

  • Severe malocclusions that would take longer than 2 years of treatment or require surgical intervention.
  • Significant periodontal disease (> 3mm pocket depth or >1 mm of recession on upper anterior teeth).
  • Active caries not under care of either a dentist or periodontist.
  • Chronic daily use of any non-steroidal anti-inflammatory medication, estrogen, calcitonin, or corticosteroids.
  • History of use or current use of any bisphosphonate medication or other medication for treatment of osteoporosis.
  • Current smoker (must not have smoked in the last 6 months).
  • Women may not be pregnant. Negative urine pregnancy tests prior to exposure to cone beam imaging is required to verify pregnancy status.
  • Any condition or use of medication which in the opinion of the investigator interferes with the biology of tooth movement.
  • Any condition which in the opinion of the investigator results in increased risk to the subject.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    AcceleDent Aura

    AcceleDent Aura device provides a light vibration at 0.25 Newtons and 30 Hz frequency for 20 minutes daily.

    Device: AcceleDent Aura

  • Sham comparator
    Sham Device

    Sham devices will look identical to active devices but will not deliver vibration to the patient.

    Device: Sham Device

Interventions

  • DeviceAcceleDent Aura
  • DeviceSham Device
06

What researchers measure

Primary outcomes

  1. Rate of Orthodontic Tooth Movement (mm/week)

    Time frame: 12 Weeks

Secondary outcomes

  1. Pain (Visual Analog Scale)

    Time frame: 3 Days After Receiving New Aligner

07

Study locations

1 site
  • University of Florida, Department of Orthodontics
    Gainesville, Florida 32610, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01962012
Lead sponsor
OrthoAccel Technologies Inc.
Collaborators
University of Florida
Responsible party
Sponsor
First posted
Oct 14, 2013
Start date
Oct 2013
Primary completion
Jun 2014
Completion
May 2016
Last update
Sep 28, 2016

Study contacts

Timothy T Wheeler, DMD, PhD
principal investigator · University of Florida

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion