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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The OrthoAccel (OATI) Celerect Device Pivotal Study - Effect of Cyclic Loading (Vibration) on Orthodontic Tooth Movement|
- The primary efficacy endpoint for the Study is the difference in the weekly rate of tooth movement between the device group and sham-control group. [ Time Frame: 6-months ] [ Designated as safety issue: No ]
|Study Start Date:||February 2009|
|Study Completion Date:||November 2011|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
|Experimental: OrthoAccel Device||
Device: OrthoAccel Device
The OA device provides a light vibration at 0.2 Newtons and 30 Hz. frequency for 20 minutes daily.
|Sham Comparator: Sham (inactive device)||
Device: Sham Device
Inactive sham device that is held in the mouth for 20 minutes.
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.
|United States, Texas|
|San Antonio, Texas, United States, 78229|
|Principal Investigator:||Peter Gakunga, DDS||University of Texas Health Science Center - San Antonio|