Effect of Intra-Oral Photobiomodulation on Orthodontic Treatment Time

Study Overview
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Brief Summary
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The aim of this study is to determine the effect of OrthoPulse™, an intra-oral LED (Light Emitting Diode) photobiomodulation device, on orthodontic treatment time. This is a double-blinded RCT with half the patients receiving treatment from a sham non-functional device, serving as controls, and the other half receiving light therapy treatment from a functional OrthoPulse™. Orthodontic treatment time for the sham-control patients are compared to that of the OrthoPulse™ patients.

Official Title
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Effect of Intra-Oral Photobiomodulation on Orthodontic Treatment Time: A Randomized Control Trial

Conditions
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Malocclusion

Intervention / Treatment
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* Other: Fixed Orthodontic Appliance Treatment
* Device: OrthoPulse™
* Device: Non-Functional 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 orthodontic treatment. Class I or Class II malocclusion (no more than ½ cusp in Class II) Non-extraction in all quadrants Non-smoker, non-use of chewing tobacco Good oral hygiene No adjunct treatment such as extra or intraoral appliances Age 12-40 Exclusion Criteria: Pregnant females Patient is currently enrolled in another clinical study Non-steroidal Anti-Inflammatory drug (NSAID) use during study (Acetominophen acceptable) Periodontally involved teeth Use of bisphosphonates Unerupted erupted teeth Teeth blocked out of alignment and unable to engage initial arch wire

Ages Eligible for Study
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Minimum Age: 12 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OrthoPulse™<br>Subjects assigned to this group receive fixed orthodontic appliance treatment in conjunction with receiving daily OrthoPulse™ treatments. | Other: Fixed Orthodontic Appliance Treatment<br>* Patients are treated for full mouth fixed orthodontic appliance 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>|
| Sham Comparator: Sham-Control OrthoPulse™<br>Subjects assigned to this group receive fixed orthodontic appliance treatment in conjunction with carrying out daily non-functional OrthoPulse™ treatments (untreated control). | Other: Fixed Orthodontic Appliance Treatment<br>* Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.<br>Device: Non-Functional OrthoPulse™<br>* Patients carry out daily sham-OrthoPulse™ treatments at home. This is a non-functional device so patients do not receive photobiomodulation therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Orthodontic Treatment Time for OrthoPulse™ and Non-OrthoPulse™ Treated Patients. | The amount of time that spans between the start of a patient's orthodontic treatment to when the qualified investigator deems the case complete, in that malocclusion is completely resolved and an acceptable clinical outcome is achieved. | 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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Photobiomodulation, Orthodontic treatment, Malocclusion, OrthoPulse™