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OpenTrials
Completed

NCT Number: NCT00830947

Effect of Cyclic Loading (Vibration) on Orthodontic Tooth Movement

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

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Key information

Conditions

Malocclusion Stomatognathic Diseases Tooth Diseases

Age range

12 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ravi Anthony

San Antonio, Texas, 78229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OrthoAccel Device

Device

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

Sham device

Device

Inactive sham device that is held in the mouth for 20 minutes.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

OrthoAccel Technologies Inc.

Industry

Registry information

Official study title

The OrthoAccel (OATI) Celerect Device Pivotal Study - Effect of Cyclic Loading (Vibration) on Orthodontic Tooth Movement

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jan 28, 2009
Registry last updated
Dec 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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