Malocclusion
Conditions
Keywords
Alignment phase, 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 the rate of anterior orthodontic alignment.
Interventions
DEVICEOrthoPulse™
Patients carry out daily OrthoPulse™ treatments at home.
Sponsors
Biolux Research Holdings, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
11 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 * Good oral hygiene as determined by the investigator * No adjunct treatment such as extra- or intra-oral appliances
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 or partially erupted maxillary teeth * Teeth blocked out of alignment and unable to engage initial arch wire * Spaces present in the maxillary arch
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 OrthoPulse™ and Non-OrthoPulse™ 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
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OrthoPulse™ Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI), in conjunction with receiving daily OrthoPulse™ treatments. Treatment and follow-up appointments per the traditional practices of the PI and dental office.
OrthoPulse™: Patients carry out daily OrthoPulse™ treatments at home. | 11 |
| Control Subjects assigned to this group receive only full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI), and no OrthoPulse™ treatments. Treatment and follow-up appointments per the traditional practices of the PI and dental office. | 9 |
| Total | 20 |
Baseline characteristics
| Characteristic | OrthoPulse™ | Control | Total |
|---|---|---|---|
| Age, Customized Age | 14.0 years STANDARD_DEVIATION 1.7 | 15.0 years STANDARD_DEVIATION 4.8 | 14.5 years STANDARD_DEVIATION 3.4 |
| Region of Enrollment United States | 11 participants | 9 participants | 20 participants |
| Sex: Female, Male Female | 8 Participants | 6 Participants | 14 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 11 | 0 / 9 |
| serious Total, serious adverse events | 0 / 11 | 0 / 9 |
Outcome results
Primary
Rate of Orthodontic Anterior Alignment in Millimetres Per Week (mm/wk) by Means of Little's Irregularity Index (LII) for OrthoPulse™ and Non-OrthoPulse™ 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 |
|---|---|---|---|
| OrthoPulse™ | Rate of Orthodontic Anterior Alignment in Millimetres Per Week (mm/wk) by Means of Little's Irregularity Index (LII) for OrthoPulse™ and Non-OrthoPulse™ Treated Patients. | 1.27 millimeters per week (mm/wk) | Standard Deviation 0.53 |
| No OrthoPulse™ | Rate of Orthodontic Anterior Alignment in Millimetres Per Week (mm/wk) by Means of Little's Irregularity Index (LII) for OrthoPulse™ and Non-OrthoPulse™ Treated Patients. | 0.43 millimeters per week (mm/wk) | Standard Deviation 0.2 |