Trial Outcomes & Findings for Effect of Intra-Oral Photobiomodulation on Orthodontic Treatment Time (NCT NCT02267850)
NCT ID: NCT02267850
Last Updated: 2018-09-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
29 participants
Primary outcome timeframe
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.
Results posted on
2018-09-21
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
14
|
|
Overall Study
COMPLETED
|
14
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
OrthoPulse™
n=15 Participants
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.
|
Sham-Control OrthoPulse™
n=14 Participants
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.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13.4 years
STANDARD_DEVIATION 1.5 • n=15 Participants
|
13.3 years
STANDARD_DEVIATION 1.0 • n=14 Participants
|
13.3 years
STANDARD_DEVIATION 1.0 • n=29 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=15 Participants
|
9 Participants
n=14 Participants
|
17 Participants
n=29 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=15 Participants
|
5 Participants
n=14 Participants
|
12 Participants
n=29 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
15 Participants
n=15 Participants
|
14 Participants
n=14 Participants
|
29 Participants
n=29 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
OrthoPulse™
n=14 Participants
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.
|
Sham-Control OrthoPulse™
n=12 Participants
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.
|
|---|---|---|
|
Overall Orthodontic Treatment Time for OrthoPulse™ and Non-OrthoPulse™ Treated Patients.
|
19.0 months
Standard Deviation 5.5
|
21.2 months
Standard Deviation 6.9
|
Adverse Events
OrthoPulse™
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham-Control OrthoPulse™
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place