Trial Outcomes & Findings for The Effect of OrthoPulse™ on the Rate of Orthodontic Tooth Movement (NCT NCT02267811)
NCT ID: NCT02267811
Last Updated: 2019-05-21
Results Overview
Rate of participants orthodontic tooth movement using Little's Index of Irregularity (LII) measured in millimeters per week during alignment.
COMPLETED
NA
33 participants
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.
2019-05-21
Participant Flow
Participant milestones
| Measure |
BX8RN: Orthodontic Treatment With OrthoPulse™ (Treatment)
Subjects assigned to this group receive orthodontic treatment in conjunction with receiving daily OrthoPulse™ treatments.
Orthodontic Treatment: Patients are treated for orthodontic 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.
|
BX8RN: Orthodontic Treatment (Control)
Subjects assigned to this group receive orthodontic treatment without OrthoPulse™ treatment.
Orthodontic Treatment: Patients are treated for orthodontic 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
|
16
|
17
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of OrthoPulse™ on the Rate of Orthodontic Tooth Movement
Baseline characteristics by cohort
| Measure |
BX8RN: OrthoPulse™ (Treatment)
n=16 Participants
Subjects assigned to this group receive orthodontic treatment in conjunction with receiving daily OrthoPulse™ treatments.
Orthodontic Treatment: Patients are treated for orthodontic 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.
|
BX8RN: Orthodontic Treatment With no OrthoPulse™ (Control)
n=17 Participants
Subjects assigned to this group receive orthodontic treatment with no daily OrthoPulse™ treatments.
Orthodontic Treatment: Patients are treated for orthodontic treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=99 Participants
|
17 participants
n=107 Participants
|
33 participants
n=206 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.Rate of participants orthodontic tooth movement using Little's Index of Irregularity (LII) measured in millimeters per week during alignment.
Outcome measures
| Measure |
BX8RN: Orthodontic Treatment With OrthoPulse™ (Treatment)
n=15 Participants
Subjects assigned to this group receive orthodontic treatment in conjunction with receiving daily OrthoPulse™ treatments.
Orthodontic Treatment: Patients are treated for orthodontic 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.
|
BX8RN: Orthodontic Treatment (Control)
n=15 Participants
Subjects assigned to this group receive orthodontic treatment without OrthoPulse™ treatment.
Orthodontic Treatment: Patients are treated for orthodontic treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.
|
|---|---|---|
|
Evaluation of Whether OrthoPulse Use Affects the Rate of Orthodontic Tooth Movement During Full Mouth Fixed Orthodontic Treatment
|
1.09 millimeters per week
Standard Deviation .68
|
.39 millimeters per week
Standard Deviation .14
|
SECONDARY 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 number of significant adverse events reported from time of participant enrolment to study completion for all study participants
Outcome measures
| Measure |
BX8RN: Orthodontic Treatment With OrthoPulse™ (Treatment)
n=15 Participants
Subjects assigned to this group receive orthodontic treatment in conjunction with receiving daily OrthoPulse™ treatments.
Orthodontic Treatment: Patients are treated for orthodontic 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.
|
BX8RN: Orthodontic Treatment (Control)
n=15 Participants
Subjects assigned to this group receive orthodontic treatment without OrthoPulse™ treatment.
Orthodontic Treatment: Patients are treated for orthodontic treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.
|
|---|---|---|
|
Safety Evidence of OrthoPulse™ Use
|
0 Adverse Events
|
0 Adverse Events
|
SECONDARY outcome
Timeframe: Assessed at six (6) months or later after starting treatment, up to two (2) years.Population: The overall number of participants is not consistent with the number of participants analyzed in this arm because the panoramic radiographs required to analyze the EARR were not available for the remaining 11 participants.
The amount of EARR experienced as assessed at six (6) months or later after starting treatment. External Apical Root Resorption can result from orthodontic tooth movement. External apical root resorption is the shortening of the root and affects root surface(s), which can result in loss of tooth structure. External apical root resorption is being determined in this study by comparing root lengths from initial to six (6) months or later after starting treatment. The measurements are taken from the crown to the root apex in millimeters. A positive number under the measure of dispersion signifies root resorption.
Outcome measures
| Measure |
BX8RN: Orthodontic Treatment With OrthoPulse™ (Treatment)
n=10 Participants
Subjects assigned to this group receive orthodontic treatment in conjunction with receiving daily OrthoPulse™ treatments.
Orthodontic Treatment: Patients are treated for orthodontic 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.
|
BX8RN: Orthodontic Treatment (Control)
n=9 Participants
Subjects assigned to this group receive orthodontic treatment without OrthoPulse™ treatment.
Orthodontic Treatment: Patients are treated for orthodontic treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.
|
|---|---|---|
|
Degree of External Apical Root Resorption (EARR)
|
0.02 millimeters
Standard Deviation .86
|
-0.11 millimeters
Standard Deviation .87
|
Adverse Events
Fixed Orthodontic Treatment With OrthoPulse™ (Treatment)
Fixed Orthodontic Treatment (Control)
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