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

Study Overview
=================
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.

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

Conditions
-----------------
Malocclusion

Intervention / Treatment
-----------------
* Other: Orthodontic Treatment
* Device: OrthoPulse™


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fixed Orthodontic Treatment with OrthoPulse™<br>Subjects assigned to this group receive orthodontic treatment in conjunction with receiving daily OrthoPulse™ treatments. | Other: Orthodontic Treatment<br>* 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.<br>Device: OrthoPulse™<br>* Participants carry out daily OrthoPulse™ treatments at home.<br>|
| Experimental: Fixed Orthodontic Treatment<br>Subjects assigned to this group receive orthodontic treatment with no OrthoPulse™ treatment. | Other: Orthodontic Treatment<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Evidence of OrthoPulse™ Use | The number of significant adverse events reported from time of participant enrolment to study completion for all study participants | 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. | Assessed at six (6) months or later after starting treatment, up to two (2) years. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Photobiomodulation, Orthodontic treatment, Malocclusion, OrthoPulse™