Trial Outcomes & Findings for OrthoPulse™ and Its Effect on the Rate of Orthodontic Tooth Alignment: A Pilot Feasibility Study (NCT NCT02267837)
NCT ID: NCT02267837
Last Updated: 2018-08-27
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 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 |
OrthoPulse™
Subjects assigned to this group receive fixed orthodontic appliance treatment in conjunction with receiving daily OrthoPulse™ treatments.
Full mouth 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.
|
No OrthoPulse™
Subjects assigned to this group receive fixed orthodontic appliance treatment only, and no OrthoPulse™ treatments.
Full mouth 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.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
9
|
|
Overall Study
COMPLETED
|
11
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
OrthoPulse™ and Its Effect on the Rate of Orthodontic Tooth Alignment: A Pilot Feasibility Study
Baseline characteristics by cohort
| Measure |
OrthoPulse™
n=11 Participants
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.
|
Control
n=9 Participants
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.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age
|
14.0 years
STANDARD_DEVIATION 1.7 • n=5 Participants
|
15.0 years
STANDARD_DEVIATION 4.8 • n=7 Participants
|
14.5 years
STANDARD_DEVIATION 3.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
9 participants
n=7 Participants
|
20 participants
n=5 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 |
OrthoPulse™
n=18 arches
Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment in conjunction with receiving daily OrthoPulse™ treatments.
Full mouth 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.
|
No OrthoPulse™
n=13 arches
Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment only, and no OrthoPulse™ treatments.
Full mouth 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.
|
|---|---|---|
|
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
|
0.43 millimeters per week (mm/wk)
Standard Deviation 0.20
|
Adverse Events
OrthoPulse™
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No 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