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Effect of Cyclic Loading (Vibration) on Orthodontic Tooth Movement

NCT ID: NCT00830947

Last Updated: 2013-12-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Malocclusion

Keywords

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Orthodontic Extraction Device Space Closure Orthodontic malocclusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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OrthoAccel Device

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

Group Type EXPERIMENTAL

OrthoAccel Device

Intervention Type DEVICE

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

Sham Device (inactive device)

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

Group Type SHAM_COMPARATOR

Sham Device

Intervention Type DEVICE

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

Interventions

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OrthoAccel Device

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

Intervention Type DEVICE

Sham Device

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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OrthoAccel Technologies Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Gakunga, DDS

Role: PRINCIPAL_INVESTIGATOR

University of Texas Health Science Center San Antonio

Locations

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Ravi Anthony

San Antonio, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37339352 (View on PubMed)

Other Identifiers

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OA-02

Identifier Type: -

Identifier Source: org_study_id