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

Biolux Research Holdings, Inc.33 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Malocclusion

Interventions

Orthodontic TreatmentOTHER

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.

Eligibility

Sex: ALLMin age: 11 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Stone Oak Orthodontics

San Antonio, Texas, United States

Outcomes

Primary Outcomes

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

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

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.

Secondary Outcomes

Safety Evidence of OrthoPulse™ Use

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

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.

Degree of External Apical Root Resorption (EARR)

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.

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

Data from ClinicalTrials.gov

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