MalocclusionPhase 4NCT01962012
Effect of AcceleDent® Aura on Orthodontic Tooth Movement With Aligners
A Phase 4 study testing AcceleDent Aura in people with Malocclusion, run by OrthoAccel Technologies Inc. at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Malocclusion
- What is being tested?
- AcceleDent Aura
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to May 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida, Department of Orthodontics
Gainesville, Florida, 32610
About this study
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.
- Conditions
- Malocclusion
- Being tested
- AcceleDent Aura, Sham Device
- Keywords
- Orthodontic, Orthodontic Treatment, Accelerated Tooth Movement, Malocclusion, Device, AcceleDent Aura, Clear Aligners
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcceleDent AuraDevice
Sham DeviceDevice
| Study group | Role | What they receive |
|---|---|---|
| AcceleDent Aura | Experimental | AcceleDent Aura device provides a light vibration at 0.25 Newtons and 30 Hz frequency for 20 minutes daily. Receives: Device: AcceleDent Aura |
| Sham Device | Sham comparator | Sham devices will look identical to active devices but will not deliver vibration to the patient. Receives: Device: Sham Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Orthodontic Tooth Movement (mm/week)
Measured: 12 Weeks
Secondary outcomes (1)
Pain (Visual Analog Scale)
Measured: 3 Days After Receiving New Aligner
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionJun 2014
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalocclusionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- OrthoAccel Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Florida
- Responsible party
- Sponsor
- Investigators
- Timothy T Wheeler, DMD, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01962012
- Sponsor's protocol ID
- OA-03
- Status last verified
- Sep 2016
- First submitted
- 8 Oct 2013
- Last updated
- 28 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of AcceleDent® Aura on Orthodontic Tooth Movement With Aligners
- ClinicalTrials.gov ID
- NCT01962012
- Acronym / sponsor ID
- OA-03
- Conditions
- Malocclusion
- Keywords
- Orthodontic, Orthodontic Treatment, Accelerated Tooth Movement, Malocclusion, Device, AcceleDent Aura, Clear Aligners
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- OrthoAccel Technologies Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Florida
- Study start
- Oct 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 14 Oct 2013 (estimated)
- Results
- Not posted in the source record
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 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AcceleDent Aura | Experimental | Device: AcceleDent AuraAcceleDent Aura device provides a light vibration at 0.25 Newtons and 30 Hz frequency for 20 minutes daily. |
| Sham Device | Sham comparator | Device: Sham DeviceSham devices will look identical to active devices but will not deliver vibration to the patient. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| AcceleDent Aura | Device | AcceleDent Aura |
| Sham Device | Device | Sham Device |
Primary outcome
Rate of Orthodontic Tooth Movement (mm/week)
Time frame: 12 Weeks
1 secondary outcome
Pain (Visual Analog Scale)
Time frame: 3 Days After Receiving New Aligner
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2016.
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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.
Timothy T Wheeler, DMD, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AcceleDent Aura in people with Malocclusion, run by OrthoAccel Technologies Inc. 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 7 inclusion and 9 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 28 Sep 2016. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of Orthodontic Tooth Movement (mm/week) (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2016.