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
Results First Received: June 20, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Malocclusion
Interventions: Device: OrthoAccel Device
Device: Sham Device

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
OrthoAccel 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 Device : Inactive sham device that is held in the mouth for 20 minutes.

Participant Flow:   Overall Study
    OrthoAccel Device     Sham (Inactive Device)  
STARTED     23     22  
COMPLETED     19     18  
NOT COMPLETED     4     4  
Lost to Follow-up                 4                 4  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
OrthoAccel 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 Device : Inactive sham device that is held in the mouth for 20 minutes.
Total Total of all reporting groups

Baseline Measures
    OrthoAccel Device     Sham (Inactive Device)     Total  
Number of Participants  
[units: participants]
  23     22     45  
Age  
[units: years]
Mean ± Standard Deviation
  21.8  ± 8.7     21.4  ± 7.8     21.6  ± 8.2  
Gender  
[units: participants]
     
Female     17     11     28  
Male     6     11     17  



  Outcome Measures

1.  Primary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Zaffer Syed, Director of Clinical & Regulatory Affairs
Organization: OrthoAccel Technologies, Inc.
phone: (832) 803-0339
e-mail: zsyed@orthoaccel.com


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