Effect of Cyclic Loading (Vibration) on Orthodontic Tooth Movement
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00830947|
Recruitment Status : Completed
First Posted : January 28, 2009
Results First Posted : December 23, 2013
Last Update Posted : December 23, 2013
|Condition or disease||Intervention/treatment||Phase|
|Malocclusion||Device: OrthoAccel Device Device: Sham Device||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The OrthoAccel (OATI) Celerect Device Pivotal Study - Effect of Cyclic Loading (Vibration) on Orthodontic Tooth Movement|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||November 2011|
Experimental: OrthoAccel Device
Device provides a light vibration at 0.25 Newtons and 30 Hz frequency for 20 minutes daily.
Device: OrthoAccel Device
The OA device provides a light vibration at 0.25 Newtons and 30 Hz frequency for 20 minutes daily.
Sham Comparator: Sham Device (inactive device)
Sham device will look identical to active devices but will not deliver vibration to the patient.
Device: Sham Device
Inactive sham device that is held in the mouth for 20 minutes.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00830947
|United States, Texas|
|San Antonio, Texas, United States, 78229|
|Principal Investigator:||Peter Gakunga, DDS||University of Texas Health Science Center - San Antonio|