Effect of Cyclic Loading (Vibration) on Orthodontic Tooth Movement

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
OrthoAccel Technologies Inc.
ClinicalTrials.gov Identifier:
NCT00830947
First received: January 26, 2009
Last updated: November 5, 2013
Last verified: November 2013

January 26, 2009
November 5, 2013
February 2009
November 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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 ]
Complete list of historical versions of study NCT00830947 on ClinicalTrials.gov Archive Site
Not Provided
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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

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Malocclusion
  • 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.
  • Experimental: OrthoAccel Device
    Device provides a light vibration at 0.25 Newtons and 30 Hz frequency for 20 minutes daily.
    Intervention: Device: OrthoAccel Device
  • Sham Comparator: Sham Device (inactive device)
    Sham device will look identical to active devices but will not deliver vibration to the patient.
    Intervention: Device: Sham Device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
November 2011
November 2011   (final data collection date for primary outcome measure)

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
Both
12 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00830947
OA-02
No
OrthoAccel Technologies Inc.
OrthoAccel Technologies Inc.
Not Provided
Principal Investigator: Peter Gakunga, DDS University of Texas Health Science Center - San Antonio
OrthoAccel Technologies Inc.
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP