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Completed

NCT Number: NCT02267811

The Effect of OrthoPulse™ on the Rate of Orthodontic Tooth Movement

This open label study is designed to evaluate the ability of OrthoPulse™ to safely and effectively increase the rate of orthodontic tooth movement with fixed appliances.

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Key information

Conditions

Malocclusion Stomatognathic Diseases Tooth Diseases

Age range

11 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stone Oak Orthodontics

San Antonio, Texas, 78232, United States

About this study

The primary aim of this study is to determine if daily OrthoPulse™ use affects the rate of orthodontic tooth movement during alignment with fixed appliances in the mandibular arch.

The secondary aim of this study is to determine whether patients treated with OrthoPulse demonstrate root resorption beyond what is commonly expected during orthodontic treatment.

The study also aims to collect confirmatory evidence on the safety of the device.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Eligible and scheduled for full mouth fixed orthodontic treatment
  • Moderate to severe crowding (LII ≥ 3 mm), with no labio-lingually displaced teeth
  • Class I or Class II by 1/2 cusp or less
  • Non-extraction in both arches
  • Age 11- 60
  • Good oral hygiene
  • Non-smokerInclud

Exclusion criteria

  • Pregnant females
  • Patient is currently enrolled in another clinical study
  • Patient decided on Invisalign® rather than braces
  • Periodontally involved teeth
  • Use of bisphosphonates (osteoporosis drugs) during the study
  • Patient plans to move over the treatment period
  • Spaces between anterior teeth

Treatment and study plan

Orthodontic treatment

Other

Patients are treated for orthodontic treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.

OrthoPulse™

Device

Participants carry out daily OrthoPulse™ treatments at home.

Primary outcomes

  1. Evaluation of Whether OrthoPulse Use Affects the Rate of Orthodontic Tooth Movement During Full Mouth Fixed Orthodontic Treatment

    Time frame: Participants will be followed for the duration of their orthodontic treatment, an expected average of 1-2 years, depending on the severity of the case.

    Rate of participants orthodontic tooth movement using Little's Index of Irregularity (LII) measured in millimeters per week during alignment.

Secondary outcomes

  1. Safety Evidence of OrthoPulse™ Use

    Time frame: Participants will be followed for the duration of their orthodontic treatment, an expected average of 1-2 years, depending on the severity of the case.

    The number of significant adverse events reported from time of participant enrolment to study completion for all study participants

  2. Degree of External Apical Root Resorption (EARR)

    Time frame: Assessed at six (6) months or later after starting treatment, up to two (2) years.

    The amount of EARR experienced as assessed at six (6) months or later after starting treatment. External Apical Root Resorption can result from orthodontic tooth movement. External apical root resorption is the shortening of the root and affects root surface(s), which can result in loss of tooth structure. External apical root resorption is being determined in this study by comparing root lengths from initial to six (6) months or later after starting treatment. The measurements are taken from the crown to the root apex in millimeters.

    A positive number under the measure of dispersion signifies root resorption.

Sponsors and collaborators

Lead sponsor

Biolux Research Holdings, Inc.

Industry

Registry information

Official study title

The Effect of OrthoPulse™ on the Rate of Orthodontic Tooth Movement During Alignment With Fixed Appliances

Acronym: BX8RN

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 20, 2014
Registry last updated
May 21, 2019

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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