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
  Purpose

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


Condition Intervention Phase
Malocclusion
Device: OrthoAccel Device
Device: Sham Device
Phase 3

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

Enrollment: 45
Study Start Date: February 2009
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Texas
Ravi Anthony
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
OrthoAccel Technologies Inc.
Investigators
Principal Investigator: Peter Gakunga, DDS University of Texas Health Science Center - San Antonio
  More Information

No publications provided

Responsible Party: OrthoAccel Technologies Inc.
ClinicalTrials.gov Identifier: NCT00830947     History of Changes
Other Study ID Numbers: OA-02
Study First Received: January 26, 2009
Results First Received: June 20, 2013
Last Updated: November 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by OrthoAccel Technologies Inc.:
Orthodontic
Extraction
Device
Space Closure
Orthodontic malocclusion

Additional relevant MeSH terms:
Malocclusion
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on August 28, 2014