OrthoPulse Gen 2 Initial Device Evaluation and Assessment of Clinical Effectiveness (CA)

Study Overview
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Brief Summary
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This is a prospective, interventional, non-randomized, control, split-mouth, open-label, single centre, private practice study aimed to evaluate the effect of tooth movement during orthodontic treatment using a removeable thermoplastic orthodontic appliance. Intrusion and extrusion will be conducted using bilaterally equivalent elastomeric forces of 50 grams. A comparison of the rate of bilateral orthodontic tooth movement will be conducted using six (6) varied photobiomodulation interventions on the maxillary (upper) and mandibular (lower) arches. The OrthoPulse Gen 2 and OrthoPulse (commercially approved) devices are being used in this clinical investigation. Each subject enrolled will go through intrusion and extrusion. All subjects will be allocated to an OrthoPulse split-mouth intervention by the investigator.

Official Title
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RI.2 OrthoPulse Gen 2 Initial Device Evaluation and Assessment of Clinical

Conditions
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Orthodontic Tooth Movement

Intervention / Treatment
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* Device: Intervention 1
* Device: Intervention 2
* Device: Intervention 3
* Device: Intervention 4
* Device: Intervention 5
* Device: Intervention 6
* Device: Intervention 7
* Device: Intervention 8


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient must be 19 years of age or older Likely to be compliant to OrthoPulse use, aligner wear, and Dental Monitoring scanning Have a compatible iOS or Android device and are willing to download the OrthoPulse and Dental Monitoring apps for frequent automatic syncing of data Exclusion Criteria: Patient is currently enrolled in another clinical study Crowding or rotations of bilateral bicuspids that would prevent or interfere with intrusion Periodontally involved teeth, acute oral infection or periodontal disease Patient has active/untreated caries Use of bisphosphonates at any time Use of drugs that may cause photosensitivity History of photosensitivity Epilepsy Pregnant or planning pregnancy during the study. Patient plans to relocate over the treatment period

Ages Eligible for Study
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Minimum Age: 19 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: Each group in this study includes a different device iteration that is being investigated in parallel.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention 1<br>Side one: No treatment Side two: OrthoPulse Gen 2 (2RP) for one minute | Device: Intervention 1<br>* Side one: No treatment Side two: OrthoPulse Gen 2 (2RP) for one minute<br>|
| Experimental: Intervention 2<br>Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RP) for one minute | Device: Intervention 2<br>* Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RP) for one minute<br>|
| Experimental: Intervention 3<br>Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RP) for 5 minutes | Device: Intervention 3<br>* Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RP) for 5 minutes<br>|
| Experimental: Intervention 4<br>Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RCW) for five minutes | Device: Intervention 4<br>* Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RCW) for five minutes<br>|
| Experimental: Intervention 5<br>Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for one minute | Device: Intervention 5<br>* Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for one minute<br>|
| Experimental: Intervention 6<br>Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for five minutes | Device: Intervention 6<br>* Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for five minutes<br>|
| Experimental: Intervention 7<br>Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for one minute | Device: Intervention 7<br>* Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for one minute<br>|
| Experimental: Intervention 8<br>Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for five minutes | Device: Intervention 8<br>* Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RBP) for five minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of orthodontic tooth movement | The rate of orthodontic tooth movement during intrusion at 36 days (±12 days) from the T0 Visit (measured in mm per week). | 36 days (±12 days) from T0 visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Pain: Questionnaire | Assess peak pain experienced over first seven (7) days of treatment during intrusion using a questions similar in nature to a Visual Analog Scale (subject to complete pain questionnaire). | 7 Days | 
| Root Resorption | Assess tooth resorption by measuring the root length of the first or second bicuspid bilaterally from baseline to T3 | 36 days (±12 days) from T0 visit | 
| Initial Safety of Device | Confirmation of safety through collection of adverse events | From enrolment to study completion, anticipated six (6) months |