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Effect of Cyclic Loading (Vibration) on Orthodontic Tooth Movement

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ClinicalTrials.gov Identifier: NCT00830947
Recruitment Status : Completed
First Posted : January 28, 2009
Results First Posted : December 23, 2013
Last Update Posted : December 23, 2013
Sponsor:
Information provided by (Responsible Party):
OrthoAccel Technologies Inc.

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

Condition or disease Intervention/treatment Phase
Malocclusion Device: OrthoAccel Device Device: Sham Device Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

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


Locations
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United States, Texas
Ravi Anthony
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
OrthoAccel Technologies Inc.
Investigators
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Principal Investigator: Peter Gakunga, DDS University of Texas Health Science Center - San Antonio
More Information
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Responsible Party: OrthoAccel Technologies Inc.
ClinicalTrials.gov Identifier: NCT00830947    
Other Study ID Numbers: OA-02
First Posted: January 28, 2009    Key Record Dates
Results First Posted: December 23, 2013
Last Update Posted: December 23, 2013
Last Verified: November 2013
Keywords provided by OrthoAccel Technologies Inc.:
Orthodontic
Extraction
Device
Space Closure
Orthodontic malocclusion
Additional relevant MeSH terms:
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Malocclusion
Tooth Diseases
Stomatognathic Diseases