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
1 other identifier
interventional
45
1 country
1
Brief Summary
To gather data indicating whether or not the OrthoAccel device speeds tooth movement in people who use orthodontics (braces).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2009
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2009
CompletedFirst Posted
Study publicly available on registry
January 28, 2009
CompletedStudy Start
First participant enrolled
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedResults Posted
Study results publicly available
December 23, 2013
CompletedDecember 23, 2013
November 1, 2013
2.7 years
January 26, 2009
June 20, 2013
November 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Rate of Orthodontic Movement of a Maxillary Canine Tooth Being Distalized to Close an Extraction Space.
Time to Space Closure, an average of 22 weeks
Study Arms (2)
OrthoAccel Device
EXPERIMENTALDevice provides a light vibration at 0.25 Newtons and 30 Hz frequency for 20 minutes daily.
Sham Device (inactive device)
SHAM COMPARATORSham device will look identical to active devices but will not deliver vibration to the patient.
Interventions
The OA device provides a light vibration at 0.25 Newtons and 30 Hz frequency for 20 minutes daily.
Inactive sham device that is held in the mouth for 20 minutes.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Any compromised medical or dental condition
- Patient currently involved in any other study
- Lives significantly outside San Antonio, TX
- use of bisphosphonates
- pregnant females
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ravi Anthony
San Antonio, Texas, 78229, United States
Related Publications (1)
El-Angbawi A, McIntyre G, Fleming PS, Bearn D. Non-surgical adjunctive interventions for accelerating tooth movement in patients undergoing orthodontic treatment. Cochrane Database Syst Rev. 2023 Jun 20;6(6):CD010887. doi: 10.1002/14651858.CD010887.pub3.
PMID: 37339352DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Zaffer Syed, Director of Clinical & Regulatory Affairs
- Organization
- OrthoAccel Technologies, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Gakunga, DDS
University of Texas Health Science Center San Antonio
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2009
First Posted
January 28, 2009
Study Start
February 1, 2009
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
December 23, 2013
Results First Posted
December 23, 2013
Record last verified: 2013-11