The Effects of Extraoral Photobiomodulation on the Rate of Orthodontic Alignment

Study Overview
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Brief Summary
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The aim of this study is to determine if extraoral OrthoPulse®, which emits extraoral LED (Light Emitting Diode) photobiomodulation (PBM), reduces the time it takes to complete orthodontic alignment.

Official Title
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The Effects of Extraoral Photobiomodulation on the Rate of Orthodontic Alignment

Conditions
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Malocclusion

Intervention / Treatment
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* Device: Extraoral OrthoPulse® PBM
* Other: Fixed Orthodontic Appliance Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Permanent dentition Class I malocclusion with irregularity score of greater than 2 mm in either arch Good oral hygiene Exclusion Criteria: Any medical or dental condition that could potentially affect study results Patients currently using any investigational drug or any other investigational device Patients planning to relocate or move during the treatment period Use of bisphosphonates Pregnant females

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extraoral OrthoPulse® PBM<br>Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment in conjunction with receiving daily extraoral OrthoPulse® photobiomudulation (PBM) treatments. | Device: Extraoral OrthoPulse® PBM<br>* Patients carry out daily extraoral OrthoPulse® PBM treatments at home.<br>Other: Fixed Orthodontic Appliance Treatment<br>* Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Orthodontic treatment procedures carried out per the traditional practices of the PI and dental office.<br>|
| Other: Orthodontic Treatment (Control)<br>Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment, only. | Other: Fixed Orthodontic Appliance Treatment<br>* Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Orthodontic treatment procedures carried out per the traditional practices of the PI and dental office.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Orthodontic Anterior Alignment in Millimetres Per Week (mm/wk) by Means of Little's Irregularity Index (LII) for Extraoral OrthoPulse® PBM and Non-OrthoPulse® PBM Treated Patients. |  | Participants followed for the time it takes to complete orthodontic anterior alignment, an expected average of 30-120 days from the start of orthodontic treatment, 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™