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Study stopped because slow enrolment.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention 1 | Experimental | Side one: No treatment Side two: OrthoPulse Gen 2 (2RP) for one minute |
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| Intervention 2 | Experimental | Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RP) for one minute |
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| Intervention 3 | Experimental | Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RP) for 5 minutes |
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| Intervention 4 | Experimental | Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RCW) for five minutes |
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| Intervention 5 | Experimental | Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for one minute |
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| Intervention 6 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention 1 | Device | Side one: No treatment Side two: OrthoPulse Gen 2 (2RP) for one minute |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Peter Brawn | Vancouver | B.C | V6A 4G8 | Canada |
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Each group in this study includes a different device iteration that is being investigated in parallel.
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Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for five minutes
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| Intervention 7 | Experimental | Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for one minute |
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| Intervention 8 | Experimental | Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for five minutes |
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| Intervention 2 | Device | Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RP) for one minute |
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| Intervention 3 | Device | Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RP) for 5 minutes |
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| Intervention 4 | Device | Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RCW) for five minutes |
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| Intervention 5 | Device | Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for one minute |
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| Intervention 6 | Device | Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for five minutes |
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| Intervention 7 | Device | Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for one minute |
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| Intervention 8 | Device | Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RBP) for five minutes |
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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 |