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

Not Applicable

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Fixed Orthodontic Treatment with OrthoPulse™	Orthodontic Treatment	Subjects assigned to this group receive orthodontic treatment in conjunction with receiving daily OrthoPulse™ treatments.
Fixed Orthodontic Treatment with OrthoPulse™	OrthoPulse™	Subjects assigned to this group receive orthodontic treatment in conjunction with receiving daily OrthoPulse™ treatments.
Fixed Orthodontic Treatment	Orthodontic Treatment	Subjects assigned to this group receive orthodontic treatment with no OrthoPulse™ treatment.

Primary Outcome Measures

Name	Time	Method
Evaluation of Whether OrthoPulse Use Affects the Rate of Orthodontic Tooth Movement During Full Mouth Fixed Orthodontic Treatment	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 Outcome Measures

Name	Time	Method
Safety Evidence of OrthoPulse™ Use	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
Degree of External Apical Root Resorption (EARR)	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.