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Completed

NCT Number: NCT01828164

The Effect of Ultrasound on Orthodontic Tooth Movement

To study whether or not the Aevo System™ medical device enhances the rate of tooth movement in human subjects who use orthodontic braces.

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Key information

Age range

12 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Site 1: University of Alberta, Facilty of Dentistry, Edmonton, Alberta, Canada

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About this study

The study will involve comparing the effects of tooth movement with and without ultrasound treatment in a split mouth design. Treatment will consist of using the Aevo System™ device for one 20 minute period per day for the duration of the trial (up to 24 weeks). Tooth position measurements will be taken from eligible patients prior to commencing usage of the study device. Follow-up visits will be scheduled for intra-oral clinical measurements and to take full-arch impressions. The Aevo System™ consists of an ultrasound emitting mouthpiece which is wire connected to an external handheld device. The mouthpiece is placed over the teeth and over the braces every day for 20 minutes in order to deliver the therapy.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Subjects who meet all of the following criteria will qualify for entry into the study:

  • Scheduled to receive orthodontic treatment or in early stage of orthodontic treatment
  • Minimum of 3 mm of extraction space (on both sides of a dental arch) to be closed either by distal movement of all 6 anterior teeth from canine to canine or by distal movement of the canines.
  • Available for follow-up visits.
  • Willing and able to sign written informed consent.
  • Healthy.
  • Has permanent dentition and between the ages of 12 and 40.
  • Good oral hygiene and compliance

Exclusion criteria

Subjects who meet any of the following criteria will be excluded from the study:

  • Any compromised medical or dental condition that prevents the subject from participating in the trial or using the medical device.
  • Any implanted assistive devices.
  • Currently involved in any other study.
  • Lives significantly outside the clinical trial site.
  • Use of bisphosphonates.
  • Pregnant females .

Treatment and study plan

Ultrasound

Device

The Aevo System™ is an ultrasound emitting dental device.

Other names: Aevo System.

Sham Comparator

Device

Ultrasound not activated in the comparator side of the device.20 minutes per day of ultrasound treatment on the active side of the device. The device consists of a mouth guard type device with transducers embedded in the mouth guard. In the split mouth design, the treatment arm consist of the side of the mouth with the transducers activated while the comparator arm has the transducers deactivated.

Primary outcomes

  1. Rate of Tooth Movement

    Time frame: 24 weeks or until the extraction space was closed (whichever came first)

    The weekly rate of tooth movement (mm/week) as compared between the treated side and the control side.

Secondary outcomes

  1. Rate of Root Resorption

    Time frame: 24 weeks or until the extraction space was closed (whichever came first)

    The weekly rate of tooth root resorption (mm/week) as compared between the treated side and the control side.

  2. Discomfort

    Time frame: 24 weeks or until the extraction space was closed (whichever came first)

    Average measured level of subject discomfort or pain. The Participant Pain Reporting Scale is used to assess the amount of pain on a 10 point scale. On the 10 point scale, 1 represents the least amount of pain and 10 represents the most amount of pain.

Sponsors and collaborators

Lead sponsor

SmileSonica Inc.

Industry

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 10, 2013
Registry last updated
May 22, 2017

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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