Clinical Trial: Effect of Cyclic Loading (Vibration) on Orthodontic Tooth Movement

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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

Detailed Summary: 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.
Sponsor: OrthoAccel Technologies Inc.

Current 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 ]

Original Primary Outcome: 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 ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: OrthoAccel Technologies Inc.

Dates:
Date Received: January 26, 2009
Date Started: February 2009
Date Completion:
Last Updated: November 5, 2013
Last Verified: November 2013