Effect of Cyclic Loading (Vibration) on Orthodontic Tooth Movement

Study Overview
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Brief Summary
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To gather data indicating whether or not the OrthoAccel device speeds tooth movement in people who use orthodontics (braces).

Detailed Description
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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.

Official Title
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The OrthoAccel (OATI) Celerect Device Pivotal Study - Effect of Cyclic Loading (Vibration) on Orthodontic Tooth Movement

Conditions
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Malocclusion

Intervention / Treatment
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* Device: OrthoAccel Device
* Device: Sham Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Any compromised medical or dental condition Patient currently involved in any other study Lives significantly outside San Antonio, TX use of bisphosphonates pregnant females

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OrthoAccel Device<br>Device provides a light vibration at 0.25 Newtons and 30 Hz frequency for 20 minutes daily. | Device: OrthoAccel Device<br>* The OA device provides a light vibration at 0.25 Newtons and 30 Hz frequency for 20 minutes daily.<br>|
| Sham Comparator: Sham Device (inactive device)<br>Sham device will look identical to active devices but will not deliver vibration to the patient. | Device: Sham Device<br>* Inactive sham device that is held in the mouth for 20 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Rate of Orthodontic Movement of a Maxillary Canine Tooth Being Distalized to Close an Extraction Space. |  | Time to Space Closure, an average of 22 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Orthodontic, Extraction, Device, Space Closure, Orthodontic malocclusion