Trials / Terminated
TerminatedNCT04386278
OrthoPulse Gen 2 Initial Device Evaluation and Assessment of Clinical Effectiveness (CA)
RI.2 OrthoPulse Gen 2 Initial Device Evaluation and Assessment of Clinical
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 56 (actual)
- Sponsor
- Biolux Research Holdings, Inc. · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Intervention 1 | Side one: No treatment Side two: OrthoPulse Gen 2 (2RP) for one minute |
| DEVICE | Intervention 2 | Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RP) for one minute |
| DEVICE | Intervention 3 | Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RP) for 5 minutes |
| DEVICE | Intervention 4 | Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RCW) for five minutes |
| DEVICE | Intervention 5 | Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for one minute |
| DEVICE | Intervention 6 | Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for five minutes |
| DEVICE | Intervention 7 | Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for one minute |
| DEVICE | Intervention 8 | Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RBP) for five minutes |
Timeline
- Start date
- 2020-01-08
- Primary completion
- 2020-06-24
- Completion
- 2020-06-24
- First posted
- 2020-05-13
- Last updated
- 2020-11-23
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT04386278. Inclusion in this directory is not an endorsement.