Malocclusion
Conditions
Keywords
Alignment phase, Photobiomodulation, Orthodontic treatment, Malocclusion, OrthoPulse™
Brief summary
The aim of this study is to determine if extraoral OrthoPulse®, which emits extraoral LED (Light Emitting Diode) photobiomodulation (PBM), reduces the time it takes to complete orthodontic alignment.
Interventions
DEVICEExtraoral OrthoPulse® PBM
Patients carry out daily extraoral OrthoPulse® PBM treatments at home.
Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Orthodontic treatment procedures carried out per the traditional practices of the PI and dental office.
Sponsors
Biolux Research Holdings, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
11 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Permanent dentition * Class I malocclusion with irregularity score of greater than 2 mm in either arch * Good oral hygiene
Exclusion criteria
* Any medical or dental condition that could potentially affect study results * Patients currently using any investigational drug or any other investigational device * Patients planning to relocate or move during the treatment period * Use of bisphosphonates * Pregnant females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of Orthodontic Anterior Alignment in Millimetres Per Week (mm/wk) by Means of Little's Irregularity Index (LII) for Extraoral OrthoPulse® PBM and Non-OrthoPulse® PBM Treated Patients. | Participants followed for the time it takes to complete orthodontic anterior alignment, an expected average of 30-120 days from the start of orthodontic treatment, depending on the severity of the case. |
Countries
Canada, Thailand, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Extra-Oral OrthoPulse™ Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI), in conjunction with receiving daily extra-oral OrthoPulse™ treatments. Treatment and follow-up appointments per the traditional practices of the PI and dental office.
Extra-Oral OrthoPulse™: Patients carry out daily extra-oral OrthoPulse™ treatments at home. | 83 |
| Control Subjects assigned to this group receive only full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI), and no extra-oral OrthoPulse™ treatments. Treatment and follow-up appointments per the traditional practices of the PI and dental office. | 18 |
| Total | 101 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did Not Meet Initial Dental Criteria | 2 | 0 |
| Overall Study | Lost to Follow-up | 4 | 0 |
| Overall Study | Pregnancy | 1 | 1 |
| Overall Study | Protocol Violation | 3 | 0 |
Baseline characteristics
| Characteristic | Extra-Oral OrthoPulse™ | Control | Total |
|---|---|---|---|
| Age, Customized Age | 18.0 years STANDARD_DEVIATION 7 | 19.5 years STANDARD_DEVIATION 7.4 | 18.3 years STANDARD_DEVIATION 7.1 |
| Region of Enrollment Canada | 13 participants | 0 participants | 13 participants |
| Region of Enrollment Thailand | 21 participants | 9 participants | 30 participants |
| Region of Enrollment United States | 49 participants | 9 participants | 58 participants |
| Sex: Female, Male Female | 56 Participants | 12 Participants | 68 Participants |
| Sex: Female, Male Male | 27 Participants | 6 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 83 | 0 / 18 |
| serious Total, serious adverse events | 0 / 83 | 0 / 18 |
Outcome results
Primary
Rate of Orthodontic Anterior Alignment in Millimetres Per Week (mm/wk) by Means of Little's Irregularity Index (LII) for Extraoral OrthoPulse® PBM and Non-OrthoPulse® PBM Treated Patients.
Time frame: Participants followed for the time it takes to complete orthodontic anterior alignment, an expected average of 30-120 days from the start of orthodontic treatment, depending on the severity of the case.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extraoral OrthoPulse® PBM and Orthodontic Treatment | Rate of Orthodontic Anterior Alignment in Millimetres Per Week (mm/wk) by Means of Little's Irregularity Index (LII) for Extraoral OrthoPulse® PBM and Non-OrthoPulse® PBM Treated Patients. | 1.12 millimeters per week (mm/wk) | Standard Deviation 1.05 |
| Orthodontic Treatment (Control) | Rate of Orthodontic Anterior Alignment in Millimetres Per Week (mm/wk) by Means of Little's Irregularity Index (LII) for Extraoral OrthoPulse® PBM and Non-OrthoPulse® PBM Treated Patients. | 0.49 millimeters per week (mm/wk) | Standard Deviation 0.4 |