OrthoPulse Gen 2 Initial Device Evaluation and Assessment of Clinical Effectiveness (CA)
NCT ID: NCT04386278
Last Updated: 2020-11-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
56 participants
INTERVENTIONAL
2020-01-08
2020-06-24
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention 1
Side one: No treatment Side two: OrthoPulse Gen 2 (2RP) for one minute
Intervention 1
Side one: No treatment Side two: OrthoPulse Gen 2 (2RP) for one minute
Intervention 2
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RP) for one minute
Intervention 2
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RP) for one minute
Intervention 3
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RP) for 5 minutes
Intervention 3
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RP) for 5 minutes
Intervention 4
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RCW) for five minutes
Intervention 4
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RCW) for five minutes
Intervention 5
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for one minute
Intervention 5
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for one minute
Intervention 6
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for five minutes
Intervention 6
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for five minutes
Intervention 7
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for one minute
Intervention 7
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for one minute
Intervention 8
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for five minutes
Intervention 8
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RBP) for five minutes
Interventions
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Intervention 1
Side one: No treatment Side two: OrthoPulse Gen 2 (2RP) for one minute
Intervention 2
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RP) for one minute
Intervention 3
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RP) for 5 minutes
Intervention 4
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RCW) for five minutes
Intervention 5
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for one minute
Intervention 6
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for five minutes
Intervention 7
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for one minute
Intervention 8
Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RBP) for five minutes
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
ALL
Yes
Sponsors
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Biolux Research Holdings, Inc.
INDUSTRY
Responsible Party
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Locations
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Dr. Peter Brawn
Vancouver, B.C, Canada
Countries
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Other Identifiers
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RI.2
Identifier Type: -
Identifier Source: org_study_id