OrthoPulse 2.0 and 2.1 Feasibility Evaluation

Study Overview
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Brief Summary
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OrthoPulse is a device that uses near-infrared light therapy in order to decrease orthodontic treatment time. The aim of this study is to evaluate OrthoPulse products modified with extended arrays, OrthoPulse 2.0 and OrthoPulse 2.1, and to assess their clinical effectiveness.

Official Title
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OrthoPulse 2.0 and 2.1 Product Evaluation and Assessing Clinical Effectiveness: A Feasibility Study

Conditions
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Malocclusion

Intervention / Treatment
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* Device: OrthoPulse 2.0
* Device: OrthoPulse 2.1
* Device: Invisalign 3.5 Day Wear
* Device: Fixed Orthodontic Appliances (Braces)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written Informed Consent must be obtained before any assessment is performed Patient must be 11 years of age or older; minors will only be included in the study with the consent of the Parent/Legal Authorized Representative (LAR) Presence of permanent dentition Eligible and scheduled for full mouth fixed orthodontic treatment or Invisalign Good oral hygiene Likely to be compliant to OrthoPulse 2.0 and 2.1 use, aligner wear and elastic wear Have a compatible iOS or Android device and are willing to download the OrthoPulse app for frequent automatic syncing of use data Exclusion Criteria: Patient is currently enrolled in another clinical study Periodontally involved teeth, acute oral infection or periodontal disease Use of bisphosphonates (osteoporosis drugs) during the study Use of drugs that may cause photosensitivity History of photosensitivity History of poor oral hygiene, per the discretion of the Principal Investigator (PI) Epilepsy Patient plans to relocate over the treatment period Smoker or use of any tobacco containing products per the discretion of the PI

Ages Eligible for Study
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Minimum Age: 11 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I-OP2.0<br>Patients receive Invisalign orthodontic treatment, with 3.5 day Aligner changes, by the qualified Principal Investigator (PI). Patients receive OrthoPulse 2.0 device. | Device: OrthoPulse 2.0<br>* Patients are given OrthoPulse 2.0, an extended OrthoPulse device with no zone control (ability for doctor to control treatment regions). Patients complete 10 minute treatments (5 minutes each arch) every day.<br>Device: Invisalign 3.5 Day Wear<br>* Patients are are fitted with sets of clear orthodontic Aligners by a qualified Principal Investigator (PI) using a ClinCheck plan by Align Technology. Aligners are worn for approximately 22 hours a day, and switched every 3.5 days.<br>|
| Experimental: I-OP2.1<br>Patients receive Invisalign orthodontic treatment, with 3.5 day Aligner changes, by the qualified Principal Investigator (PI). Patients receive OrthoPulse 2.1 device. | Device: OrthoPulse 2.1<br>* Patients are given OrthoPulse 2.1, an extended OrthoPulse device with zone control (ability for doctor to control treatment regions). Patients complete 10 minute treatments (5 minutes each arch) every day.<br>Device: Invisalign 3.5 Day Wear<br>* Patients are are fitted with sets of clear orthodontic Aligners by a qualified Principal Investigator (PI) using a ClinCheck plan by Align Technology. Aligners are worn for approximately 22 hours a day, and switched every 3.5 days.<br>|
| Experimental: F-OP2.0<br>Patients receive fixed appliance orthodontic treatment by the qualified Principal Investigator (PI). Patients receive OrthoPulse 2.0 device. | Device: OrthoPulse 2.0<br>* Patients are given OrthoPulse 2.0, an extended OrthoPulse device with no zone control (ability for doctor to control treatment regions). Patients complete 10 minute treatments (5 minutes each arch) every day.<br>Device: Fixed Orthodontic Appliances (Braces)<br>* Patients are fitted with a set of brackets and wires, as per standard orthodontic treatment by a qualified Principal Investigator (PI).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feedback on general experience | Assess doctor and patient feedback on the general experience with OrthoPulse 2.0 and OrthoPulse 2.1 as measured in the electronic data capture system. | Through Study Completion, approx. 2 years | 
| Feedback on clinical performance | Assess doctor subjective and objective feedback on the clinical performance of OrthoPulse 2.0 and OrthoPulse 2.1 as measured in the electronic data capture system. | Through Study Completion, approx. 2 years | 
| Adverse events | Confirm initial safety of OrthoPulse 2.0 and OrthoPulse 2.1 | Through Study Completion, approx. 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biolux, Malocclusion, Photobiomodulation, OrthoPulse, Low-level laser therapy, Orthodontics