Trial Outcomes & Findings for The Effects of Extraoral Photobiomodulation on the Rate of Orthodontic Alignment (NCT NCT02267824)
NCT ID: NCT02267824
Last Updated: 2018-08-27
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
101 participants
Primary outcome timeframe
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.
Results posted on
2018-08-27
Participant Flow
Participant milestones
| Measure |
Extraoral OrthoPulse® PBM
Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment in conjunction with receiving daily extraoral OrthoPulse® PBM treatments.
|
Orthodontic Treatment (Control)
Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment only.
|
|---|---|---|
|
Overall Study
STARTED
|
83
|
18
|
|
Overall Study
COMPLETED
|
73
|
17
|
|
Overall Study
NOT COMPLETED
|
10
|
1
|
Reasons for withdrawal
| Measure |
Extraoral OrthoPulse® PBM
Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment in conjunction with receiving daily extraoral OrthoPulse® PBM treatments.
|
Orthodontic Treatment (Control)
Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment only.
|
|---|---|---|
|
Overall Study
Pregnancy
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
4
|
0
|
|
Overall Study
Protocol Violation
|
3
|
0
|
|
Overall Study
Did Not Meet Initial Dental Criteria
|
2
|
0
|
Baseline Characteristics
The Effects of Extraoral Photobiomodulation on the Rate of Orthodontic Alignment
Baseline characteristics by cohort
| Measure |
Extra-Oral OrthoPulse™
n=83 Participants
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.
|
Control
n=18 Participants
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.
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age
|
18.0 years
STANDARD_DEVIATION 7.0 • n=99 Participants
|
19.5 years
STANDARD_DEVIATION 7.4 • n=107 Participants
|
18.3 years
STANDARD_DEVIATION 7.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
13 participants
n=99 Participants
|
0 participants
n=107 Participants
|
13 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=99 Participants
|
9 participants
n=107 Participants
|
58 participants
n=206 Participants
|
|
Region of Enrollment
Thailand
|
21 participants
n=99 Participants
|
9 participants
n=107 Participants
|
30 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 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.Outcome measures
| Measure |
Extraoral OrthoPulse® PBM and Orthodontic Treatment
n=73 Participants
Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment in conjunction with receiving daily extraoral OrthoPulse® PBM treatments.
|
Orthodontic Treatment (Control)
n=17 Participants
Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment, only.
|
|---|---|---|
|
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
|
0.49 millimeters per week (mm/wk)
Standard Deviation 0.40
|
Adverse Events
Extraoral OrthoPulse® PBM
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Orthodontic Treatment (Control)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Extraoral OrthoPulse® PBM
n=83 participants at risk
Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment in conjunction with receiving daily extraoral OrthoPulse® photobiomudulation (PBM) treatments.
|
Orthodontic Treatment (Control)
n=18 participants at risk
Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment, only.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Cheek redness
|
1.2%
1/83 • Number of events 1
|
0.00%
0/18
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place