An interventional study of Fixed Orthodontic Appliance Treatment and OrthoPulse™ in Malocclusion, sponsored by Biolux Research Holdings, Inc.. Completed at 1 site in United States. Open to participants aged 12 Years to 40 Years. Per ClinicalTrials.gov, last updated 2018-09-21.
Sponsored by Biolux Research Holdings, Inc. · Not applicable, Interventional, and Treatment
The aim of this study is to determine the effect of OrthoPulse™, an intra-oral LED (Light Emitting Diode) photobiomodulation device, on orthodontic treatment time. This is a double-blinded RCT with half the patients receiving treatment from a sham non-functional device, serving as controls, and the other half receiving light therapy treatment from a functional OrthoPulse™. Orthodontic treatment time for the sham-control patients are compared to that of the OrthoPulse™ patients.
457 studies on the registry are indexed under Malocclusion; 89 are open to participants now.
This study's enrollment of 29 is below the median of 36 across 372 interventional studies indexed under Malocclusion.
Browse Malocclusion studies →Biolux Research Holdings, Inc. is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects assigned to this group receive fixed orthodontic appliance treatment in conjunction with receiving daily OrthoPulse™ treatments.
Other: Fixed Orthodontic Appliance Treatment · Device: OrthoPulse™
Subjects assigned to this group receive fixed orthodontic appliance treatment in conjunction with carrying out daily non-functional OrthoPulse™ treatments (untreated control).
Other: Fixed Orthodontic Appliance Treatment · Device: Non-Functional OrthoPulse™
Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.
Patients carry out daily OrthoPulse™ treatments at home.
Patients carry out daily sham-OrthoPulse™ treatments at home. This is a non-functional device so patients do not receive photobiomodulation therapy.
Overall Orthodontic Treatment Time for OrthoPulse™ and Non-OrthoPulse™ Treated Patients.
The amount of time that spans between the start of a patient's orthodontic treatment to when the qualified investigator deems the case complete, in that malocclusion is completely resolved and an acceptable clinical outcome is achieved.
Time frame: Participants will be followed for the duration of their orthodontic treatment, an expected average of 1-2 years, depending on the severity of the case.
| Milestone | OrthoPulse™ | Sham-Control OrthoPulse™ |
|---|---|---|
| Started | 15 | 14 |
| Completed | 14 | 12 |
| Not completed | 1 | 2 |
The amount of time that spans between the start of a patient's orthodontic treatment to when the qualified investigator deems the case complete, in that malocclusion is completely resolved and an acceptable clinical outcome is achieved.
| months | OrthoPulse™ | Sham-Control OrthoPulse™ |
|---|---|---|
| Overall Orthodontic Treatment Time for OrthoPulse™ and Non-OrthoPulse™ Treated Patients. | 19.0 ± 5.5 | 21.2 ± 6.9 |
Collected over Whole study duration, 2 years.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| OrthoPulse™ | — | 0/15 (0%) | 0/15 (0%) |
| Sham-Control OrthoPulse™ | — | 0/14 (0%) | 0/14 (0%) |
| Age, Continuous(years) | OrthoPulse™ | Sham-Control OrthoPulse™ | Total |
|---|---|---|---|
| Mean | 13.4 ± 1.5 | 13.3 ± 1.0 | 13.3 ± 1.0 |
| Sex: Female, Male(Participants) | OrthoPulse™ | Sham-Control OrthoPulse™ | Total |
|---|---|---|---|
| Female | 8 | 9 | 17 |
| Male | 7 | 5 | 12 |
| Race and Ethnicity Not Collected(Participants) | OrthoPulse™ | Sham-Control OrthoPulse™ | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | OrthoPulse™ | Sham-Control OrthoPulse™ | Total |
|---|---|---|---|
| United States | 15 | 14 | 29 |
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Biolux Research Holdings, Inc.