Effect of Cyclic Loading (Vibration) on Orthodontic Tooth Movement - Full Text View

Sponsored by:	OrthoAccel Technologies Inc.
Information provided by:	OrthoAccel Technologies Inc.
ClinicalTrials.gov Identifier:	NCT00830947

Purpose

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

Condition	Intervention	Phase
Malocclusion Tooth Extractions	Device: OrthoAccel Device Device: Sham Device	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	The OrthoAccel (OATI) Celerect Device Pivotal Study - Effect of Cyclic Loading (Vibration) on Orthodontic Tooth Movement

Further study details as provided by OrthoAccel Technologies Inc.:

Primary Outcome Measures:

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 ]

Estimated Enrollment:	32
Study Start Date:	February 2009
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
OrthoAccel Device: Experimental	Device: OrthoAccel Device The OA device provides a light vibration at 0.2 Newtons and 30 Hz. frequency for 20 minutes daily.
Sham (inactive device): Sham Comparator	Device: Sham Device Inactive sham device that is held in the mouth for 20 minutes.

Detailed Description:

This is a randomized, blinded study that will follow 30 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.

Eligibility

Ages Eligible for Study:	12 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00830947

Contacts

Contact: Ravi Anthony, DDS

210-567-3500

btarver@orthoaccel.com

Locations

United States, Texas
Ravi Anthony	Recruiting
San Antonio, Texas, United States, 78229
Contact: Anthony 210-567-3500

Sponsors and Collaborators

OrthoAccel Technologies Inc.

More Information

No publications provided

Responsible Party:	OrthoAccel Technologies Inc. ( Brent Tarver, Vice President Clinical Affairs and Technology Development )
Study ID Numbers:	OA-02
Study First Received:	January 26, 2009
Last Updated:	May 8, 2009
ClinicalTrials.gov Identifier:	NCT00830947 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by OrthoAccel Technologies Inc.:

Orthodontic
Extraction
Device
Space Closure
Orthodontic malocclusion requiring tooth extraction and space closure

Study placed in the following topic categories:

Tooth Diseases
Malocclusion
Stomatognathic Diseases

Additional relevant MeSH terms:

Tooth Diseases
Malocclusion
Stomatognathic Diseases

ClinicalTrials.gov processed this record on September 03, 2009