Tooth MovementNCT02438280
Accelerated Tooth Movement With AcceleDent® and Aligners - a Pilot Project
A study testing AcceleDent, Vibrational Device in people with Tooth Movement and Malocclusion, run by University of Washington at 3 sites in 2 countries.
Trial summary
The AcceleDent® device has been introduced to the specialty of orthodontics in order to reduce treatment time. The theory behind AcceleDent® is that high frequency vibratory forces (30Hz) delivered to the teeth will stimulate the bone remodeling that is necessary for tooth movement to occur more quickly. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth Movement, Malocclusion
- What is being tested?
- AcceleDent, Vibrational Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 3 sitesin 2 countries
- Study dates
- May 2015to Mar 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with malocclusions that require minor or no anterior-posterior or transverse correction in the posterior teeth, and are planned for <= 25 aligners to complete treatment.
- Treatment must be dual arch in order for patients to qualify for this study.
- Patients must be 18 years or older
Who cannot join
- Patients with systematic diseases or syndromes
- Patients with a history or current use of Bisphosphonates
- Patients with current use of nonsteroidal anti-inflammatory drugs (NSAIDs)prostaglandin inhibitors.
- Patients with generalized moderate to severe periodontitis
- Patients with active oral hard tissue or soft tissue lesions
- Patients with chronic oral and maxillofacial conditions such as trigeminal neuralgia, temporomandibular disorder and orofacial pain.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Canada2 sites
Dr. Sandra Tai
Richmond, British Columbia, V7C 5L9
Dr. Sandra Tai
Vancouver, British Columbia, V5H 4K7
About this study
The AcceleDent® device has been introduced to the specialty of orthodontics in order to reduce treatment time. The theory behind AcceleDent® is that high frequency vibratory forces (30Hz) delivered to the teeth will stimulate the bone remodeling that is necessary for tooth movement to occur more quickly.
Additionally, one claim of the AcceleDent® product is that it may reduce pain and discomfort during orthodontic treatment.
This study will be a parallel group, triple-blind randomized clinical trial comparing two groups of subjects with 12 participants in each group. Subjects will be randomized to receive one of two vibrational units, which will differ in frequency and/or amplitude of vibration. The subjects will be asked to change their aligners every week instead of every 2 weeks, which is common with Invisalign.
Read the detailed description
This study will be a parallel group, triple-blind randomized clinical trial comparing two groups of subjects with 12 participants in each group. Subjects will be randomized to receive one of two vibrational units, which will differ in frequency and/or amplitude of vibration. The subjects will be asked to change their aligners every week instead of every 2 weeks, which is common with Invisalign.
- Conditions
- Tooth Movement, Malocclusion
- Being tested
- AcceleDent, Vibrational Device
- Keywords
- Orthodontic, Orthodontic treatment, Accelerated orthodontics, Vibration
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcceleDent, Vibrational DeviceDevice
Also called AcceleDent Aura
20 minutes of vibration each day
| Study group | Role | What they receive |
|---|---|---|
| Active Vibration | Experimental | Use of Active Vibration (AcceleDent device) 20 minutes each day during treatment with aligners Receives: Device: AcceleDent, Vibrational Device |
| Sham Vibration | Active comparator | Use of Sham Vibration (Sham AcceleDent device) 20 minutes each day during treatment with aligners Receives: Device: AcceleDent, Vibrational Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to Complete Treatment Aligners in Conjunction With an Active and Placebo Vibration Device (AcceleDent® Aura)
The outcome was the ability to complete the initial set of aligners using either an active vibration device or a placebo vibration device. Regardless of the group assignment, patients were asked to change their aligners each week, and we tracked the percentage that were able to complete their series of aligners.
Measured: 6 months
Secondary outcomes (1)
Final Alignment Scores of the Upper and Lower Incisors
Final alignment was measured using Little's incisor irregularity index. This index sums the displacement of the contact points of the anterior teeth, to produce a millimetric number. The lower the score, the more perfect the alignment.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study startMay 2015
- Primary completionJul 2016
- Study completionMar 2017
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.
- Other trials for Tooth MovementStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Greg Huang, University of Washington
- Investigators
- Greg Huang, Principal investigator, UW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02438280
- Sponsor's protocol ID
- 49073
- Status last verified
- Sep 2018
- First submitted
- 4 May 2015
- Last updated
- 30 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Tooth Movement With AcceleDent® and Aligners - a Pilot Project
- ClinicalTrials.gov ID
- NCT02438280
- Acronym / sponsor ID
- 49073
- Conditions
- Tooth Movement, Malocclusion
- Keywords
- Orthodontic, Orthodontic treatment, Accelerated orthodontics, Vibration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 8 May 2015 (estimated)
- Results
- Posted 21 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The AcceleDent® device has been introduced to the specialty of orthodontics in order to reduce treatment time. The theory behind AcceleDent® is that high frequency vibratory forces (30Hz) delivered to the teeth will stimulate the bone remodeling that is necessary for tooth movement to occur more quickly.
Additionally, one claim of the AcceleDent® product is that it may reduce pain and discomfort during orthodontic treatment.
This study will be a parallel group, triple-blind randomized clinical trial comparing two groups of subjects with 12 participants in each group. Subjects will be randomized to receive one of two vibrational units, which will differ in frequency and/or amplitude of vibration. The subjects will be asked to change their aligners every week instead of every 2 weeks, which is common with Invisalign.
Detailed description
This study will be a parallel group, triple-blind randomized clinical trial comparing two groups of subjects with 12 participants in each group. Subjects will be randomized to receive one of two vibrational units, which will differ in frequency and/or amplitude of vibration. The subjects will be asked to change their aligners every week instead of every 2 weeks, which is common with Invisalign.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Vibration | Experimental | Device: AcceleDent, Vibrational DeviceUse of Active Vibration (AcceleDent device) 20 minutes each day during treatment with aligners |
| Sham Vibration | Active comparator | Device: AcceleDent, Vibrational DeviceUse of Sham Vibration (Sham AcceleDent device) 20 minutes each day during treatment with aligners |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with malocclusions that require minor or no anterior-posterior or transverse correction in the posterior teeth, and are planned for <= 25 aligners to complete treatment.
- Treatment must be dual arch in order for patients to qualify for this study.
- Patients must be 18 years or older
Key exclusion criteria (6 listed)
- Patients with systematic diseases or syndromes
- Patients with a history or current use of Bisphosphonates
- Patients with current use of nonsteroidal anti-inflammatory drugs (NSAIDs)prostaglandin inhibitors.
- Patients with generalized moderate to severe periodontitis
- Patients with active oral hard tissue or soft tissue lesions
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, Vibrational DeviceAlso: AcceleDent Aura20 minutes of vibration each day | Device | Active Vibration, Sham Vibration |
Primary outcome
Ability to Complete Treatment Aligners in Conjunction With an Active and Placebo Vibration Device (AcceleDent® Aura)
Time frame: 6 months
The outcome was the ability to complete the initial set of aligners using either an active vibration device or a placebo vibration device. Regardless of the group assignment, patients were asked to change their aligners each week, and we tracked the percentage that were able to complete their series of aligners.
1 secondary outcome
Final Alignment Scores of the Upper and Lower Incisors
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Greg Huang principal investigator
UW
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AcceleDent, Vibrational Device in people with Tooth Movement and Malocclusion, run by University of Washington at 3 sites in 2 countries.
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 3 inclusion and 6 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 30 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada, 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 21 Aug 2018). 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?
Ability to Complete Treatment Aligners in Conjunction With an Active and Placebo Vibration Device (AcceleDent® Aura) (time frame: 6 months). 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 30 Oct 2018.