Effect of Cyclic Loading (Vibration) on Orthodontic Tooth Movement

Phase 3

Completed

• Conditions: Malocclusion
• Interventions: Device: OrthoAccel Device; Device: Sham Device

• Registration Number: NCT00830947
• Lead Sponsor: OrthoAccel Technologies Inc.

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.

Study Timeline

• Study First Submitted: 2009-01-26
• Study First Submitted QC: 2009-01-27
• Study First Posted: 2009-01-28
• Study Start: 2009-02
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Results First Submitted: 2013-06-20
• Status Verified: 2013-11
• Results First Submitted QC: 2013-11-05
• Last Update Submitted: 2013-11-05
• Results First Posted: 2013-12-23
• Last Update Posted: 2013-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OrthoAccel Device	OrthoAccel Device	Device provides a light vibration at 0.25 Newtons and 30 Hz frequency for 20 minutes daily.
Sham Device (inactive device)	Sham Device	Sham device will look identical to active devices but will not deliver vibration to the patient.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ravi Anthony; 🇺🇸 San Antonio, Texas, United States