Malocclusion
Conditions
Keywords
Photobiomodulation, Orthodontic treatment, Malocclusion, OrthoPulse™
Brief summary
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.
Interventions
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.
DEVICEOrthoPulse™
Patients carry out daily OrthoPulse™ treatments at home.
DEVICENon-Functional OrthoPulse™
Patients carry out daily sham-OrthoPulse™ treatments at home. This is a non-functional device so patients do not receive photobiomodulation therapy.
Sponsors
Biolux Research Holdings, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Presence of permanent dentition * Eligible and scheduled for full mouth fixed orthodontic treatment. * Class I or Class II malocclusion (no more than ½ cusp in Class II) * Non-extraction in all quadrants * Non-smoker, non-use of chewing tobacco * Good oral hygiene * No adjunct treatment such as extra or intraoral appliances * Age 12-40
Exclusion criteria
* Pregnant females * Patient is currently enrolled in another clinical study * Non-steroidal Anti-Inflammatory drug (NSAID) use during study (Acetominophen acceptable) * Periodontally involved teeth * Use of bisphosphonates * Unerupted erupted teeth * Teeth blocked out of alignment and unable to engage initial arch wire
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Orthodontic Treatment Time for OrthoPulse™ and Non-OrthoPulse™ Treated Patients. | 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. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OrthoPulse™ Subjects assigned to this group receive fixed orthodontic appliance treatment in conjunction with receiving daily OrthoPulse™ treatments.
Fixed Orthodontic Appliance Treatment: 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.
OrthoPulse™: Patients carry out daily OrthoPulse™ treatments at home. | 15 |
| Sham-Control OrthoPulse™ Subjects assigned to this group receive fixed orthodontic appliance treatment in conjunction with carrying out daily non-functional OrthoPulse™ treatments (untreated control).
Fixed Orthodontic Appliance Treatment: 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.
Non-Functional OrthoPulse™: Patients carry out daily sham-OrthoPulse™ treatments at home. This is a non-functional device so patients do not receive photobiomodulation therapy. | 14 |
| Total | 29 |
Baseline characteristics
| Characteristic | Sham-Control OrthoPulse™ | Total | OrthoPulse™ |
|---|---|---|---|
| Age, Continuous | 13.3 years STANDARD_DEVIATION 1 | 13.3 years STANDARD_DEVIATION 1 | 13.4 years STANDARD_DEVIATION 1.5 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 14 Participants | 29 Participants | 15 Participants |
| Sex: Female, Male Female | 9 Participants | 17 Participants | 8 Participants |
| Sex: Female, Male Male | 5 Participants | 12 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 0 / 14 |
| serious Total, serious adverse events | 0 / 15 | 0 / 14 |
Outcome results
Primary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OrthoPulse™ | Overall Orthodontic Treatment Time for OrthoPulse™ and Non-OrthoPulse™ Treated Patients. | 19.0 months | Standard Deviation 5.5 |
| Sham-Control OrthoPulse™ | Overall Orthodontic Treatment Time for OrthoPulse™ and Non-OrthoPulse™ Treated Patients. | 21.2 months | Standard Deviation 6.9 |