Effect of Cyclic Loading (Vibration) on Orthodontic Tooth Movement

OrthoAccel Technologies

Status and phase: Completed; Phase 3

Conditions: Malocclusion

Treatments: Device: Sham Device; Device: OrthoAccel Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT00830947

OA-02

Details and patient eligibility

About

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

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 12 to 40 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 2 patient groups

OrthoAccel Device

Experimental group

Description:

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

Treatment:

Device: OrthoAccel Device

Sham Device (inactive device)

Sham Comparator group

Description:

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

Treatment:

Device: Sham Device