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

Study Overview
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Brief Summary
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The aim of this study is to determine efficacy of OrthoPulse photobiomodulation on the rate of tooth movement during alignment for Subjects receiving fixed appliance orthodontic treatment.

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

Conditions
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Malocclusion

Intervention / Treatment
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* Device: Fixed Appliance Orthodontic Treatment
* Device: OrthoPulse™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of permanent dentition Eligible and scheduled for full-mouth, fixed-appliance orthodontic treatment Moderate to severe crowding (LII ≥ 3 mm), with no labio-lingually displaced teeth Class I or Class II malocclusion by ½ cusp or less Non-extraction in both arches Age 11-60 Good oral hygiene Non-smoker; non-use of chewing tobacco Exclusion Criteria: Subject is currently enrolled in another clinical study Subject decided on Invisalign rather than braces Periodontally involved teeth Use of bisphosphonates (osteoporosis drugs) during the study Subject plans to relocate over the treatment period Spaces between anterior teeth Subject has dental implants or an implanted prosthesis Sponsor employees, the Investigator and staff, as well as their immediate family members

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a two-arm, parallel, open-label, non-randomized, controlled, private practice study designed to evaluate the intended purposes of the investigation.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 (Control)<br>Subjects assigned to this group receive fixed appliance orthodontic treatment only | Device: Fixed Appliance Orthodontic Treatment<br>* Patients receive fixed appliance orthodontic treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.<br>|
| Experimental: Group 2 (OP1)<br>Subjects assigned to this group receive fixed appliance orthodontic treatment in conjunction with receiving daily OrthoPulse™ treatments. | Device: Fixed Appliance Orthodontic Treatment<br>* Patients receive fixed appliance 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>* Patients carry out daily OrthoPulse™ treatments at home.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of tooth movement in OrthoPulse treated and non-OrthoPulse treated patients | Rate of tooth movement will be evaluated based on the duration of time and amount of tooth movement required to reach Little's Irregularity Index (LII) of less than approximately 2 mm but greater than 0 mm, as determined by the qualified investigator. | From start of treatment until Little's Irregularity Index (LII) reaches less than approximately 2 mm but greater than 0 mm, no more than 6 months after the start of treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of OrthoPulse PBM on external apical root resorption (EARR) | Root lengths from patients will be measured using panoramic radiographs at the start of treatment and 6 months after the start of treatment. These measurements will be used to determine and compare EARR between each of the two groups. | 6 months after the start of orthodontic treatment | 
| Risk of OrthoPulse PBM to the patient. | Patients from both groups will be questioned and assessed at regularly scheduled visits for treatment-related adverse events. | 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 | 

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