Effect of Cyclic Loading (Vibration) on Orthodontic Tooth Movement

Malocclusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00830947
• Other study ID #: OA-02
• Status: Completed
• Phase: Phase 3
• First received: January 26, 2009
• Last updated: November 5, 2013
• Start date: February 2009
• Est. completion date: November 2011

Study information

• Verified date: November 2013
• Source: OrthoAccel Technologies Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malocclusion

Intervention

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

Locations

Country	Name	City	State
United States	Ravi Anthony	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
OrthoAccel Technologies Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No