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Effect of Cyclic Loading (Vibration) on Orthodontic Tooth Movement

Primary Purpose

Malocclusion

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
OrthoAccel Device
Sham Device
Sponsored by
OrthoAccel Technologies Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion focused on measuring Orthodontic, Extraction, Device, Space Closure, Orthodontic malocclusion

Eligibility Criteria

12 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ravi Anthony

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

OrthoAccel Device

Sham Device (inactive device)

Arm Description

Device provides a light vibration at 0.25 Newtons and 30 Hz frequency for 20 minutes daily.

Sham device will look identical to active devices but will not deliver vibration to the patient.

Outcomes

Primary Outcome Measures

The Rate of Orthodontic Movement of a Maxillary Canine Tooth Being Distalized to Close an Extraction Space.

Secondary Outcome Measures

Full Information

First Posted
January 26, 2009
Last Updated
November 5, 2013
Sponsor
OrthoAccel Technologies Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00830947
Brief Title
Effect of Cyclic Loading (Vibration) on Orthodontic Tooth Movement
Official Title
The OrthoAccel (OATI) Celerect Device Pivotal Study - Effect of Cyclic Loading (Vibration) on Orthodontic Tooth Movement
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OrthoAccel Technologies Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion
Keywords
Orthodontic, Extraction, Device, Space Closure, Orthodontic malocclusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OrthoAccel Device
Arm Type
Experimental
Arm Description
Device provides a light vibration at 0.25 Newtons and 30 Hz frequency for 20 minutes daily.
Arm Title
Sham Device (inactive device)
Arm Type
Sham Comparator
Arm Description
Sham device will look identical to active devices but will not deliver vibration to the patient.
Intervention Type
Device
Intervention Name(s)
OrthoAccel Device
Intervention Description
The OA device provides a light vibration at 0.25 Newtons and 30 Hz frequency for 20 minutes daily.
Intervention Type
Device
Intervention Name(s)
Sham Device
Intervention Description
Inactive sham device that is held in the mouth for 20 minutes.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Gakunga, DDS
Organizational Affiliation
University of Texas Health Science Center - San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ravi Anthony
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

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Effect of Cyclic Loading (Vibration) on Orthodontic Tooth Movement

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