MalocclusionPhase 3NCT00830947
Effect of Cyclic Loading (Vibration) on Orthodontic Tooth Movement
A Phase 3 study testing OrthoAccel Device in people with Malocclusion, run by OrthoAccel Technologies Inc. at 1 site in United States.
Trial summary
To gather data indicating whether or not the OrthoAccel device speeds tooth movement in people who use orthodontics (braces). Read more about this study
- Who is it for?
- Ages 12 to 40 years
- Conditions the study is for
- Malocclusion
- What is being tested?
- OrthoAccel Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Nov 2011
- Phase
- Phase 3
- 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 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Permanent dentition between the ages of 12 and 40
- Minimum of 3 mm of extraction space to be closed by distal movement of all 6 anterior teeth from canine to canine or by distal movement of the canines
- Good oral hygiene and compliance
Who cannot join
- Any compromised medical or dental condition
- Patient currently involved in any other study
- Lives significantly outside San Antonio, TX
- use of bisphosphonates
- pregnant females
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The OrthoAccel (OATI) Celerect Device Pivotal Study - Effect of Cyclic Loading (Vibration) on Orthodontic Tooth Movement
To gather data indicating whether or not the OrthoAccel device speeds tooth movement in people who use orthodontics (braces).
Read the detailed description
This is a randomized, blinded study that will follow 32 patients for up to six months. Patients will have a minimum of 3 mm of extraction space that needs to be closed by moving the anterior teeth or canine distally. Patients will have standard orthodontic treatment and temporary anchorage devices for tooth movement and space closure. Half the patients will receive a functioning device and half the patients will receive a sham-device. Patients will use the device for 20 minutes daily; the device has a mouthpiece for the patient to lightly bite into plus a connected enclosure that stays outside the mouth. The enclosure provides a light vibration.
- Conditions
- Malocclusion
- Being tested
- OrthoAccel Device, Sham Device
- Keywords
- Orthodontic, Extraction, Device, Space Closure, Orthodontic malocclusion
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrthoAccel DeviceDevice
The OA device provides a light vibration at 0.25 Newtons and 30 Hz frequency for 20 minutes daily.
Sham DeviceDevice
Inactive sham device that is held in the mouth for 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| OrthoAccel Device | Experimental | Device provides a light vibration at 0.25 Newtons and 30 Hz frequency for 20 minutes daily. Receives: Device: OrthoAccel Device |
| Sham Device (inactive device) | Sham comparator | Sham device 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.
The Rate of Orthodontic Movement of a Maxillary Canine Tooth Being Distalized to Close an Extraction Space.
Measured: Time to Space Closure, an average of 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionNov 2011
- Study completionNov 2011
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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- OrthoAccel Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Gakunga, DDS, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00830947
- Sponsor's protocol ID
- OA-02
- Status last verified
- Nov 2013
- First submitted
- 26 Jan 2009
- Last updated
- 23 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
El-Angbawi A, McIntyre G, Fleming PS, Bearn D. Non-surgical adjunctive interventions for accelerating tooth movement in patients undergoing orthodontic treatment. Cochrane Database Syst Rev. 2023 Jun 20;6(6):CD010887. doi: 10.1002/14651858.CD010887.pub3.
PubMed 37339352
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The OrthoAccel (OATI) Celerect Device Pivotal Study - Effect of Cyclic Loading (Vibration) on Orthodontic Tooth Movement
- ClinicalTrials.gov ID
- NCT00830947
- Acronym / sponsor ID
- OA-02
- Conditions
- Malocclusion
- Keywords
- Orthodontic, Extraction, Device, Space Closure, Orthodontic malocclusion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- OrthoAccel Technologies Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 28 Jan 2009 (estimated)
- Results
- Posted 23 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To gather data indicating whether or not the OrthoAccel device speeds tooth movement in people who use orthodontics (braces).
Detailed description
This is a randomized, blinded study that will follow 32 patients for up to six months. Patients will have a minimum of 3 mm of extraction space that needs to be closed by moving the anterior teeth or canine distally. Patients will have standard orthodontic treatment and temporary anchorage devices for tooth movement and space closure. Half the patients will receive a functioning device and half the patients will receive a sham-device. Patients will use the device for 20 minutes daily; the device has a mouthpiece for the patient to lightly bite into plus a connected enclosure that stays outside the mouth. The enclosure provides a light vibration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OrthoAccel Device | Experimental | Device: OrthoAccel DeviceDevice provides a light vibration at 0.25 Newtons and 30 Hz frequency for 20 minutes daily. |
| Sham Device (inactive device) | Sham comparator | Device: Sham DeviceSham device will look identical to active devices but will not deliver vibration to the patient. |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Permanent dentition between the ages of 12 and 40
- Minimum of 3 mm of extraction space to be closed by distal movement of all 6 anterior teeth from canine to canine or by distal movement of the canines
- Good oral hygiene and compliance
Key exclusion criteria (5 listed)
- Any compromised medical or dental condition
- Patient currently involved in any other study
- Lives significantly outside San Antonio, TX
- use of bisphosphonates
- 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 |
|---|---|---|
| OrthoAccel DeviceThe OA device provides a light vibration at 0.25 Newtons and 30 Hz frequency for 20 minutes daily. | Device | OrthoAccel Device |
| Sham DeviceInactive sham device that is held in the mouth for 20 minutes. | Device | Sham Device (inactive device) |
Primary outcome
The Rate of Orthodontic Movement of a Maxillary Canine Tooth Being Distalized to Close an Extraction Space.
Time frame: Time to Space Closure, an average of 22 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37339352El-Angbawi A, McIntyre G, Fleming PS, Bearn D. Non-surgical adjunctive interventions for accelerating tooth movement in patients undergoing orthodontic treatment. Cochrane Database Syst Rev. 2023 Jun 20;6(6):CD010887. doi: 10.1002/14651858.CD010887.pub3.
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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.
Peter Gakunga, DDS principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing OrthoAccel Device 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 3 inclusion and 5 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 23 Dec 2013. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Dec 2013). 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?
The Rate of Orthodontic Movement of a Maxillary Canine Tooth Being Distalized to Close an Extraction Space. (time frame: Time to Space Closure, an average of 22 weeks). 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 NCT00830947, 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 23 Dec 2013.