Trial Outcomes & Findings for Analysis of Orthodontic Tooth Movement Using 3D Imaging (NCT NCT03398798)
NCT ID: NCT03398798
Last Updated: 2020-05-01
Results Overview
Little's Index measures the distance between contact points on adjacent teeth. Little's Index will be measured at two time points (0 weeks and 6 weeks).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
Baseline and 6 weeks
Results posted on
2020-05-01
Participant Flow
Participant milestones
| Measure |
.014" With Twin Brackets
.014" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia Metal Twin brackets.
.014": .014" CuNiTi orthodontic arch wire
Twin brackets: Ormco Insignia Metal Twin brackets
|
.016" With Twin Brackets
.016" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia Metal Twin brackets.
.016": .016" CuNiTi orthodontic arch wire
Twin brackets: Ormco Insignia Metal Twin brackets
|
.014" With Self-ligating Brackets
.014" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia SL (self-ligating) brackets.
.014": .014" CuNiTi orthodontic arch wire
Self-ligating (SL) brackets: Ormco Insignia SL brackets
|
.016" With Self-ligating Brackets
.016" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia SL (self-ligating) brackets.
.016": .016" CuNiTi orthodontic arch wire
Self-ligating brackets: Ormco Insignia SL brackets
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
9
|
9
|
|
Overall Study
COMPLETED
|
9
|
9
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
.014" With Twin Brackets
n=9 Participants
.014" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia Metal Twin brackets.
.014": .014" CuNiTi orthodontic arch wire
Twin brackets: Ormco Insignia Metal Twin brackets
|
.016" With Twin Brackets
n=9 Participants
.016" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia Metal Twin brackets.
.016": .016" CuNiTi orthodontic arch wire
Twin brackets: Ormco Insignia Metal Twin brackets
|
.014" With Self-ligating Brackets
n=9 Participants
.014" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia SL (self-ligating) brackets.
.014": .014" CuNiTi orthodontic arch wire
Self-ligating brackets: Ormco Insignia SL brackets
|
.016" With Self-ligating Brackets
n=9 Participants
.016" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia SL (self-ligating) brackets.
.016": .016" CuNiTi orthodontic arch wire
Self-ligating brackets: Ormco Insignia SL brackets
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
17.2 years
STANDARD_DEVIATION 3.4 • n=9 Participants
|
14.4 years
STANDARD_DEVIATION 2.2 • n=9 Participants
|
14.9 years
STANDARD_DEVIATION 2.7 • n=9 Participants
|
18.0 years
STANDARD_DEVIATION 6.4 • n=9 Participants
|
16.2 years
STANDARD_DEVIATION 4.2 • n=36 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=9 Participants
|
5 Participants
n=9 Participants
|
6 Participants
n=9 Participants
|
4 Participants
n=9 Participants
|
20 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=9 Participants
|
4 Participants
n=9 Participants
|
3 Participants
n=9 Participants
|
5 Participants
n=9 Participants
|
16 Participants
n=36 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
9 Participants
n=9 Participants
|
9 Participants
n=9 Participants
|
9 Participants
n=9 Participants
|
9 Participants
n=9 Participants
|
36 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 weeksLittle's Index measures the distance between contact points on adjacent teeth. Little's Index will be measured at two time points (0 weeks and 6 weeks).
Outcome measures
| Measure |
.014" With Twin Brackets
n=9 Participants
.014" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia Metal Twin brackets.
.014": .014" CuNiTi orthodontic arch wire
Twin brackets: Ormco Insignia Metal Twin brackets
|
.016" With Twin Brackets
n=9 Participants
.016" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia Metal Twin brackets.
.016": .016" CuNiTi orthodontic arch wire
Twin brackets: Ormco Insignia Metal Twin brackets
|
.014" With Self-ligating Brackets
n=9 Participants
.014" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia SL (self-ligating) brackets.
.014": .014" CuNiTi orthodontic arch wire
Self-ligating brackets: Ormco Insignia SL brackets
|
.016" With Self-ligating Brackets
n=9 Participants
.016" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia SL (self-ligating) brackets.
.016": .016" CuNiTi orthodontic arch wire
Self-ligating brackets: Ormco Insignia SL brackets
|
|---|---|---|---|---|
|
Change in Little's Index From Baseline to 6 Weeks
|
-2.5 mm
Standard Deviation 2.2
|
-2.9 mm
Standard Deviation 1.8
|
-2.3 mm
Standard Deviation 1.8
|
-2.6 mm
Standard Deviation 2.4
|
PRIMARY outcome
Timeframe: 6 weeks and 12 weeksLittle's Index measures the distance between contact points on adjacent teeth. Little's Index will be measured at two time points (6 weeks and 12 weeks).
Outcome measures
| Measure |
.014" With Twin Brackets
n=9 Participants
.014" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia Metal Twin brackets.
.014": .014" CuNiTi orthodontic arch wire
Twin brackets: Ormco Insignia Metal Twin brackets
|
.016" With Twin Brackets
n=9 Participants
.016" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia Metal Twin brackets.
.016": .016" CuNiTi orthodontic arch wire
Twin brackets: Ormco Insignia Metal Twin brackets
|
.014" With Self-ligating Brackets
n=9 Participants
.014" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia SL (self-ligating) brackets.
.014": .014" CuNiTi orthodontic arch wire
Self-ligating brackets: Ormco Insignia SL brackets
|
.016" With Self-ligating Brackets
n=9 Participants
.016" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia SL (self-ligating) brackets.
.016": .016" CuNiTi orthodontic arch wire
Self-ligating brackets: Ormco Insignia SL brackets
|
|---|---|---|---|---|
|
Change in Little's Index From 6 Weeks to 12 Weeks
|
-0.8 mm
Standard Deviation 1.0
|
-0.9 mm
Standard Deviation 0.8
|
-0.2 mm
Standard Deviation 0.7
|
-0.4 mm
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksClinical linear measurements (mm) in x-, y-, and z-translation will be measured at two time points (0 weeks and 6 weeks) to determine the linear (translational) change in tooth position during that time.
Outcome measures
| Measure |
.014" With Twin Brackets
n=9 Participants
.014" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia Metal Twin brackets.
.014": .014" CuNiTi orthodontic arch wire
Twin brackets: Ormco Insignia Metal Twin brackets
|
.016" With Twin Brackets
n=9 Participants
.016" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia Metal Twin brackets.
.016": .016" CuNiTi orthodontic arch wire
Twin brackets: Ormco Insignia Metal Twin brackets
|
.014" With Self-ligating Brackets
n=9 Participants
.014" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia SL (self-ligating) brackets.
.014": .014" CuNiTi orthodontic arch wire
Self-ligating brackets: Ormco Insignia SL brackets
|
.016" With Self-ligating Brackets
n=9 Participants
.016" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia SL (self-ligating) brackets.
.016": .016" CuNiTi orthodontic arch wire
Self-ligating brackets: Ormco Insignia SL brackets
|
|---|---|---|---|---|
|
Linear Change in Tooth Position From Baseline to 6 Weeks (Translation)
Translation along the x-axis
|
.03 mm
Standard Deviation .15
|
-.05 mm
Standard Deviation .18
|
-.14 mm
Standard Deviation .28
|
-.09 mm
Standard Deviation .23
|
|
Linear Change in Tooth Position From Baseline to 6 Weeks (Translation)
Translation along the y-axis
|
.05 mm
Standard Deviation .09
|
.03 mm
Standard Deviation .21
|
-.08 mm
Standard Deviation .12
|
.06 mm
Standard Deviation .34
|
|
Linear Change in Tooth Position From Baseline to 6 Weeks (Translation)
Translation along the z-axis
|
-.23 mm
Standard Deviation .34
|
-.18 mm
Standard Deviation .28
|
-.22 mm
Standard Deviation .3
|
-.28 mm
Standard Deviation .47
|
SECONDARY outcome
Timeframe: 6 weeks and 12 weeksClinical linear measurements (mm) in x-, y-, and z-translation will be measured at two time points (6 weeks and 12 weeks) to determine the linear (translational) change in tooth position during that time.
Outcome measures
| Measure |
.014" With Twin Brackets
n=9 Participants
.014" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia Metal Twin brackets.
.014": .014" CuNiTi orthodontic arch wire
Twin brackets: Ormco Insignia Metal Twin brackets
|
.016" With Twin Brackets
n=9 Participants
.016" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia Metal Twin brackets.
.016": .016" CuNiTi orthodontic arch wire
Twin brackets: Ormco Insignia Metal Twin brackets
|
.014" With Self-ligating Brackets
n=9 Participants
.014" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia SL (self-ligating) brackets.
.014": .014" CuNiTi orthodontic arch wire
Self-ligating brackets: Ormco Insignia SL brackets
|
.016" With Self-ligating Brackets
n=9 Participants
.016" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia SL (self-ligating) brackets.
.016": .016" CuNiTi orthodontic arch wire
Self-ligating brackets: Ormco Insignia SL brackets
|
|---|---|---|---|---|
|
Linear Change in Tooth Position From 6 Weeks to 12 Weeks (Translation)
Translation along the x-axis
|
.05 mm
Standard Deviation .08
|
.05 mm
Standard Deviation .20
|
.01 mm
Standard Deviation .11
|
.03 mm
Standard Deviation .17
|
|
Linear Change in Tooth Position From 6 Weeks to 12 Weeks (Translation)
Translation along the y-axis
|
.03 mm
Standard Deviation .24
|
.03 mm
Standard Deviation .13
|
-.01 mm
Standard Deviation .09
|
.03 mm
Standard Deviation .18
|
|
Linear Change in Tooth Position From 6 Weeks to 12 Weeks (Translation)
Translation along the z-axis
|
-.16 mm
Standard Deviation .32
|
.00 mm
Standard Deviation .22
|
-.07 mm
Standard Deviation .23
|
.00 mm
Standard Deviation .15
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksClinical angular measurements (degree) in x-, y-, and z-rotation will be measured at two time points (0 weeks and 6 weeks) to determine the angular (rotational) change in tooth position during that time.
Outcome measures
| Measure |
.014" With Twin Brackets
n=9 Participants
.014" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia Metal Twin brackets.
.014": .014" CuNiTi orthodontic arch wire
Twin brackets: Ormco Insignia Metal Twin brackets
|
.016" With Twin Brackets
n=9 Participants
.016" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia Metal Twin brackets.
.016": .016" CuNiTi orthodontic arch wire
Twin brackets: Ormco Insignia Metal Twin brackets
|
.014" With Self-ligating Brackets
n=9 Participants
.014" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia SL (self-ligating) brackets.
.014": .014" CuNiTi orthodontic arch wire
Self-ligating brackets: Ormco Insignia SL brackets
|
.016" With Self-ligating Brackets
n=9 Participants
.016" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia SL (self-ligating) brackets.
.016": .016" CuNiTi orthodontic arch wire
Self-ligating brackets: Ormco Insignia SL brackets
|
|---|---|---|---|---|
|
Angular Change in Tooth Position From Baseline to 6 Weeks (Rotation)
Rotation around the x-axis
|
1.95 degrees
Standard Deviation 3.09
|
1.52 degrees
Standard Deviation 2.84
|
1.97 degrees
Standard Deviation 2.47
|
1.91 degrees
Standard Deviation 3.17
|
|
Angular Change in Tooth Position From Baseline to 6 Weeks (Rotation)
Rotation around the y-axis
|
1.37 degrees
Standard Deviation 1.71
|
.99 degrees
Standard Deviation 1.26
|
1.33 degrees
Standard Deviation 1.99
|
1.78 degrees
Standard Deviation 2.50
|
|
Angular Change in Tooth Position From Baseline to 6 Weeks (Rotation)
Rotation around the z-axis
|
.66 degrees
Standard Deviation 1.54
|
.79 degrees
Standard Deviation 1.10
|
.95 degrees
Standard Deviation 1.45
|
1.59 degrees
Standard Deviation 3.21
|
SECONDARY outcome
Timeframe: 6 weeks and 12 weeksClinical angular measurements (degree) in x-, y-, and z-rotation will be measured at two time points (6 weeks and 12 weeks) to determine the angular (rotational) change in tooth position during that time.
Outcome measures
| Measure |
.014" With Twin Brackets
n=9 Participants
.014" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia Metal Twin brackets.
.014": .014" CuNiTi orthodontic arch wire
Twin brackets: Ormco Insignia Metal Twin brackets
|
.016" With Twin Brackets
n=9 Participants
.016" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia Metal Twin brackets.
.016": .016" CuNiTi orthodontic arch wire
Twin brackets: Ormco Insignia Metal Twin brackets
|
.014" With Self-ligating Brackets
n=9 Participants
.014" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia SL (self-ligating) brackets.
.014": .014" CuNiTi orthodontic arch wire
Self-ligating brackets: Ormco Insignia SL brackets
|
.016" With Self-ligating Brackets
n=9 Participants
.016" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia SL (self-ligating) brackets.
.016": .016" CuNiTi orthodontic arch wire
Self-ligating brackets: Ormco Insignia SL brackets
|
|---|---|---|---|---|
|
Angular Change in Tooth Position From 6 Weeks to 12 Weeks (Rotation)
Rotation around the x-axis
|
.82 degrees
Standard Deviation 2.00
|
1.07 degrees
Standard Deviation 1.81
|
.66 degrees
Standard Deviation 1.50
|
.40 degrees
Standard Deviation 1.59
|
|
Angular Change in Tooth Position From 6 Weeks to 12 Weeks (Rotation)
Rotation around the y-axis
|
.86 degrees
Standard Deviation 2.13
|
.39 degrees
Standard Deviation 1.34
|
.40 degrees
Standard Deviation 1.08
|
-.10 degrees
Standard Deviation 1.33
|
|
Angular Change in Tooth Position From 6 Weeks to 12 Weeks (Rotation)
Rotation around the z-axis
|
.16 degrees
Standard Deviation 1.33
|
.18 degrees
Standard Deviation .83
|
-.13 degrees
Standard Deviation 1.21
|
-.68 degrees
Standard Deviation 2.21
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: Due to loss of key study personnel these data were not collected
A repeated measure linear regression model conducted to evaluate any correlation between the degrees of malalignment and the rate of tooth movement.
Outcome measures
Outcome data not reported
Adverse Events
.014" With Twin Brackets
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
.016" With Twin Brackets
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
.014" With Self-ligating Brackets
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
.016" With Self-ligating Brackets
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
Christian Piers, DDS, MS, MFA
University of North Carolina at Chapel Hill
Phone: (828) 433-1242
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place