NCT00830947

Effect of Cyclic Loading (Vibration) on Orthodontic Tooth Movement

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: OrthoAccel Technologies Inc. · Industry
• Sex: All
• Age: 12 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Malocclusion

Interventions

Type	Name	Description
DEVICE	OrthoAccel Device	The OA device provides a light vibration at 0.25 Newtons and 30 Hz frequency for 20 minutes daily.
DEVICE	Sham Device	Inactive sham device that is held in the mouth for 20 minutes.

Timeline

• Start date: 2009-02-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2009-01-28
• Last updated: 2013-12-23
• Results posted: 2013-12-23

Locations

1 site across 1 country: United States