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Analysis of Orthodontic Tooth Movement Using 3D Imaging

Analysis of Orthodontic Tooth Movement Using 3D Imaging

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03398798
Enrollment
36
Registered
2018-01-12
Start date
2018-01-15
Completion date
2018-11-29
Last updated
2020-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tooth Crowding, Dental Crowding, Malocclusion

Keywords

archwire dimension, ligation method, bracket type

Brief summary

Purpose: This project aims to study the effects of wire dimension and ligation method (bracket type) on the first stage of orthodontic treatment using 3D imaging. Participants: Up to 80 patients at UNC School of Dentistry or Selden Orthodontics between the ages of 10 and 45, inclusive, who have been previously diagnosed with malocclusion requiring orthodontic treatment (braces) and are otherwise healthy. Procedures (methods): Subjects receiving standard of care (SOC) orthodontic treatment will be randomized to one of two commonly used orthodontic archwires (.014 or .016 diameter). Subjects will be further subdivided for analysis based on the type of bracket (twin or self-ligating) that their clinician uses in their treatment. We will review the 3D digital images of each subject's dentition recorded as part of SOC at the 0-, 6- and 12-week visits. We will retrieve the archwires when they are removed per SOC by the clinician at the 12-week time point.

Detailed description

Many archwire dimensions and two main bracket types (twin and self-ligating) are available to orthodontists for the first stage of orthodontic treatment, but little objective clinical evidence is available to indicate which archwire dimension and bracket type is ideal for a given patient with an individual type and degree of malalignment during this stage. A limited clinical trial will be conducted to collect and analyze this data. The aim of this study is to study the effect of wire dimension, timing and ligation method on leveling and aligning in orthodontic treatment using 3D imaging. The study's specific aims are as follows: 1. To analyze the effect of wire dimension (.014 vs. .016) and time-course (first six weeks or second six weeks) on Stage I treatment 2. To correlate clinical tooth movements with bench data for four types of malalignment 1. In-out 2. Rotation 3. Tip 4. Vertical step 3. To analyze the effect of ligation method (twin vs. self-ligating) on Stage I treatment These specific aims will serve to address the following hypothesis: Archwire dimension affects tooth movement in Stage I of orthodontic treatment, depending upon variation time-course (due to force decay of superelastic wires) and method of ligation (bracket type). This will be tested in a total of 80 patients who are undergoing active treatment in the University of North Carolina (UNC) orthodontic graduate clinic or at Selden Orthodontics. There will be four different groups in this study. In the twin bracket cohort, half the patients will be treated with .014 dimension wire and half will be treated with .016 dimension wire. In the self-ligating bracket cohort, half the patients will be treated with .014 dimension wire, and half will be treated with .016 dimension wire. If the hypotheses are shown to be correct, then the subset of society receiving orthodontic treatment will be able to benefit from selection of bracket types and archwire dimensions that match their individual types and degrees of malalignment. This will allow for more efficient tooth movement with less unwanted movement, and could lead to shorter treatment times and less discomfort.

Interventions

DEVICE.014

.014 CuNiTi orthodontic arch wire

DEVICE.016

.016 CuNiTi orthodontic arch wire

DEVICETwin brackets

Ormco Insignia Metal Twin brackets

Ormco Insignia SL brackets

Sponsors

University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

Neither subjects nor the treating orthodontists will know whether a .014 or 0.16 dimension wire is being used. The investigator will assign wire dimensions using a random number generator and distribute the wires to the treating orthodontists with the archwire dimension number removed from the package. The outcomes assessor will be blinded as to which patients were treated with which archwires while analyzing the digital models of the teeth. Because there is a clear visual difference between twin and self-ligating brackets, there will be no blinding with regard to ligation method (bracket type).

Intervention model description

There will be four different groups in this study, with each planned to consist of 20 patients (40 dental arches). In the twin bracket cohort, 40 dental arches are planned to be treated with .014 dimension wire, and 40 dental arches are planned to be treated with .016 dimension wire. In the self-ligating bracket cohort, 40 dental arches are planned to be treated with .014 dimension wire, and 40 dental arches are planned to be treated with .016 dimension wire.

Eligibility

Sex/Gender
ALL
Age
10 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* In the initial stage of active treatment at the University of North Carolina graduate orthodontic clinic or Selden Orthodontics * Non-extraction treatment * Maxillary and mandibular Little Index between 1-15 mm (this is a measurement of crowding) * Presence of all permanent anterior teeth * Age 10-45 years * Consent to participate in the study

Exclusion criteria

* Systemic diseases such as diabetes, hypertension, temporomandibular disorders (TMD), craniofacial syndrome, etc. * Any spacing between anterior teeth * Subjects who have incisor mandibular plane angle (IMPA) greater than or equal to 100 degrees * Anterior tooth completely blocked from the arch form * Periodontal pocketing of any teeth greater than 4 mm * Maxillary and mandibular Little Index \>15 mm (This is a measurement of crowding. A Little Index of \>15 mm indicates a need for a smaller dimension arch wire)

Design outcomes

Primary

MeasureTime frameDescription
Change in Little's Index From Baseline to 6 WeeksBaseline 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).
Change in Little's Index From 6 Weeks to 12 Weeks6 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).

Secondary

MeasureTime frameDescription
Angular Change in Tooth Position From Baseline to 6 Weeks (Rotation)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.
Linear Change in Tooth Position From Baseline to 6 Weeks (Translation)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.
Correlation Between Degrees of Malalignment and Rate of Tooth MovementBaseline and 12 weeksA repeated measure linear regression model conducted to evaluate any correlation between the degrees of malalignment and the rate of tooth movement.
Angular Change in Tooth Position From 6 Weeks to 12 Weeks (Rotation)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.
Linear Change in Tooth Position From 6 Weeks to 12 Weeks (Translation)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.

Countries

United States

Participant flow

Participants by arm

ArmCount
.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
9
.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
9
.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 brackets: Ormco Insignia SL brackets
9
.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
9
Total36

Baseline characteristics

Characteristic.016 With Twin Brackets.014 With Self-ligating Brackets.016 With Self-ligating BracketsTotal.014 With Twin Brackets
Age, Continuous14.4 years
STANDARD_DEVIATION 2.2
14.9 years
STANDARD_DEVIATION 2.7
18.0 years
STANDARD_DEVIATION 6.4
16.2 years
STANDARD_DEVIATION 4.2
17.2 years
STANDARD_DEVIATION 3.4
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United States
9 Participants9 Participants9 Participants36 Participants9 Participants
Sex: Female, Male
Female
5 Participants6 Participants4 Participants20 Participants5 Participants
Sex: Female, Male
Male
4 Participants3 Participants5 Participants16 Participants4 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 90 / 90 / 90 / 9
other
Total, other adverse events
0 / 90 / 90 / 90 / 9
serious
Total, serious adverse events
0 / 90 / 90 / 90 / 9

Outcome results

Primary

Change in Little's Index From 6 Weeks to 12 Weeks

Little'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).

Time frame: 6 weeks and 12 weeks

ArmMeasureValue (MEAN)Dispersion
.014 With Twin BracketsChange in Little's Index From 6 Weeks to 12 Weeks-0.8 mmStandard Deviation 1
.016 With Twin BracketsChange in Little's Index From 6 Weeks to 12 Weeks-0.9 mmStandard Deviation 0.8
.014 With Self-ligating BracketsChange in Little's Index From 6 Weeks to 12 Weeks-0.2 mmStandard Deviation 0.7
.016 With Self-ligating BracketsChange in Little's Index From 6 Weeks to 12 Weeks-0.4 mmStandard Deviation 0.8
Primary

Change in Little's Index From Baseline to 6 Weeks

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).

Time frame: Baseline and 6 weeks

ArmMeasureValue (MEAN)Dispersion
.014 With Twin BracketsChange in Little's Index From Baseline to 6 Weeks-2.5 mmStandard Deviation 2.2
.016 With Twin BracketsChange in Little's Index From Baseline to 6 Weeks-2.9 mmStandard Deviation 1.8
.014 With Self-ligating BracketsChange in Little's Index From Baseline to 6 Weeks-2.3 mmStandard Deviation 1.8
.016 With Self-ligating BracketsChange in Little's Index From Baseline to 6 Weeks-2.6 mmStandard Deviation 2.4
Secondary

Angular Change in Tooth Position From 6 Weeks to 12 Weeks (Rotation)

Clinical 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.

Time frame: 6 weeks and 12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
.014 With Twin BracketsAngular Change in Tooth Position From 6 Weeks to 12 Weeks (Rotation)Rotation around the x-axis.82 degreesStandard Deviation 2
.014 With Twin BracketsAngular Change in Tooth Position From 6 Weeks to 12 Weeks (Rotation)Rotation around the z-axis.16 degreesStandard Deviation 1.33
.014 With Twin BracketsAngular Change in Tooth Position From 6 Weeks to 12 Weeks (Rotation)Rotation around the y-axis.86 degreesStandard Deviation 2.13
.016 With Twin BracketsAngular Change in Tooth Position From 6 Weeks to 12 Weeks (Rotation)Rotation around the x-axis1.07 degreesStandard Deviation 1.81
.016 With Twin BracketsAngular Change in Tooth Position From 6 Weeks to 12 Weeks (Rotation)Rotation around the z-axis.18 degreesStandard Deviation 0.83
.016 With Twin BracketsAngular Change in Tooth Position From 6 Weeks to 12 Weeks (Rotation)Rotation around the y-axis.39 degreesStandard Deviation 1.34
.014 With Self-ligating BracketsAngular Change in Tooth Position From 6 Weeks to 12 Weeks (Rotation)Rotation around the y-axis.40 degreesStandard Deviation 1.08
.014 With Self-ligating BracketsAngular Change in Tooth Position From 6 Weeks to 12 Weeks (Rotation)Rotation around the x-axis.66 degreesStandard Deviation 1.5
.014 With Self-ligating BracketsAngular Change in Tooth Position From 6 Weeks to 12 Weeks (Rotation)Rotation around the z-axis-.13 degreesStandard Deviation 1.21
.016 With Self-ligating BracketsAngular Change in Tooth Position From 6 Weeks to 12 Weeks (Rotation)Rotation around the x-axis.40 degreesStandard Deviation 1.59
.016 With Self-ligating BracketsAngular Change in Tooth Position From 6 Weeks to 12 Weeks (Rotation)Rotation around the z-axis-.68 degreesStandard Deviation 2.21
.016 With Self-ligating BracketsAngular Change in Tooth Position From 6 Weeks to 12 Weeks (Rotation)Rotation around the y-axis-.10 degreesStandard Deviation 1.33
Secondary

Angular Change in Tooth Position From Baseline to 6 Weeks (Rotation)

Clinical 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.

Time frame: Baseline and 6 weeks

ArmMeasureGroupValue (MEAN)Dispersion
.014 With Twin BracketsAngular Change in Tooth Position From Baseline to 6 Weeks (Rotation)Rotation around the x-axis1.95 degreesStandard Deviation 3.09
.014 With Twin BracketsAngular Change in Tooth Position From Baseline to 6 Weeks (Rotation)Rotation around the z-axis.66 degreesStandard Deviation 1.54
.014 With Twin BracketsAngular Change in Tooth Position From Baseline to 6 Weeks (Rotation)Rotation around the y-axis1.37 degreesStandard Deviation 1.71
.016 With Twin BracketsAngular Change in Tooth Position From Baseline to 6 Weeks (Rotation)Rotation around the x-axis1.52 degreesStandard Deviation 2.84
.016 With Twin BracketsAngular Change in Tooth Position From Baseline to 6 Weeks (Rotation)Rotation around the z-axis.79 degreesStandard Deviation 1.1
.016 With Twin BracketsAngular Change in Tooth Position From Baseline to 6 Weeks (Rotation)Rotation around the y-axis.99 degreesStandard Deviation 1.26
.014 With Self-ligating BracketsAngular Change in Tooth Position From Baseline to 6 Weeks (Rotation)Rotation around the y-axis1.33 degreesStandard Deviation 1.99
.014 With Self-ligating BracketsAngular Change in Tooth Position From Baseline to 6 Weeks (Rotation)Rotation around the x-axis1.97 degreesStandard Deviation 2.47
.014 With Self-ligating BracketsAngular Change in Tooth Position From Baseline to 6 Weeks (Rotation)Rotation around the z-axis.95 degreesStandard Deviation 1.45
.016 With Self-ligating BracketsAngular Change in Tooth Position From Baseline to 6 Weeks (Rotation)Rotation around the x-axis1.91 degreesStandard Deviation 3.17
.016 With Self-ligating BracketsAngular Change in Tooth Position From Baseline to 6 Weeks (Rotation)Rotation around the z-axis1.59 degreesStandard Deviation 3.21
.016 With Self-ligating BracketsAngular Change in Tooth Position From Baseline to 6 Weeks (Rotation)Rotation around the y-axis1.78 degreesStandard Deviation 2.5
Secondary

Correlation Between Degrees of Malalignment and Rate of Tooth Movement

A repeated measure linear regression model conducted to evaluate any correlation between the degrees of malalignment and the rate of tooth movement.

Time frame: Baseline and 12 weeks

Population: Due to loss of key study personnel these data were not collected

Secondary

Linear Change in Tooth Position From 6 Weeks to 12 Weeks (Translation)

Clinical 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.

Time frame: 6 weeks and 12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
.014 With Twin BracketsLinear Change in Tooth Position From 6 Weeks to 12 Weeks (Translation)Translation along the x-axis.05 mmStandard Deviation 0.08
.014 With Twin BracketsLinear Change in Tooth Position From 6 Weeks to 12 Weeks (Translation)Translation along the z-axis-.16 mmStandard Deviation 0.32
.014 With Twin BracketsLinear Change in Tooth Position From 6 Weeks to 12 Weeks (Translation)Translation along the y-axis.03 mmStandard Deviation 0.24
.016 With Twin BracketsLinear Change in Tooth Position From 6 Weeks to 12 Weeks (Translation)Translation along the x-axis.05 mmStandard Deviation 0.2
.016 With Twin BracketsLinear Change in Tooth Position From 6 Weeks to 12 Weeks (Translation)Translation along the z-axis.00 mmStandard Deviation 0.22
.016 With Twin BracketsLinear Change in Tooth Position From 6 Weeks to 12 Weeks (Translation)Translation along the y-axis.03 mmStandard Deviation 0.13
.014 With Self-ligating BracketsLinear Change in Tooth Position From 6 Weeks to 12 Weeks (Translation)Translation along the y-axis-.01 mmStandard Deviation 0.09
.014 With Self-ligating BracketsLinear Change in Tooth Position From 6 Weeks to 12 Weeks (Translation)Translation along the x-axis.01 mmStandard Deviation 0.11
.014 With Self-ligating BracketsLinear Change in Tooth Position From 6 Weeks to 12 Weeks (Translation)Translation along the z-axis-.07 mmStandard Deviation 0.23
.016 With Self-ligating BracketsLinear Change in Tooth Position From 6 Weeks to 12 Weeks (Translation)Translation along the x-axis.03 mmStandard Deviation 0.17
.016 With Self-ligating BracketsLinear Change in Tooth Position From 6 Weeks to 12 Weeks (Translation)Translation along the z-axis.00 mmStandard Deviation 0.15
.016 With Self-ligating BracketsLinear Change in Tooth Position From 6 Weeks to 12 Weeks (Translation)Translation along the y-axis.03 mmStandard Deviation 0.18
Secondary

Linear Change in Tooth Position From Baseline to 6 Weeks (Translation)

Clinical 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.

Time frame: Baseline and 6 weeks

ArmMeasureGroupValue (MEAN)Dispersion
.014 With Twin BracketsLinear Change in Tooth Position From Baseline to 6 Weeks (Translation)Translation along the x-axis.03 mmStandard Deviation 0.15
.014 With Twin BracketsLinear Change in Tooth Position From Baseline to 6 Weeks (Translation)Translation along the z-axis-.23 mmStandard Deviation 0.34
.014 With Twin BracketsLinear Change in Tooth Position From Baseline to 6 Weeks (Translation)Translation along the y-axis.05 mmStandard Deviation 0.09
.016 With Twin BracketsLinear Change in Tooth Position From Baseline to 6 Weeks (Translation)Translation along the x-axis-.05 mmStandard Deviation 0.18
.016 With Twin BracketsLinear Change in Tooth Position From Baseline to 6 Weeks (Translation)Translation along the z-axis-.18 mmStandard Deviation 0.28
.016 With Twin BracketsLinear Change in Tooth Position From Baseline to 6 Weeks (Translation)Translation along the y-axis.03 mmStandard Deviation 0.21
.014 With Self-ligating BracketsLinear Change in Tooth Position From Baseline to 6 Weeks (Translation)Translation along the y-axis-.08 mmStandard Deviation 0.12
.014 With Self-ligating BracketsLinear Change in Tooth Position From Baseline to 6 Weeks (Translation)Translation along the x-axis-.14 mmStandard Deviation 0.28
.014 With Self-ligating BracketsLinear Change in Tooth Position From Baseline to 6 Weeks (Translation)Translation along the z-axis-.22 mmStandard Deviation 0.3
.016 With Self-ligating BracketsLinear Change in Tooth Position From Baseline to 6 Weeks (Translation)Translation along the x-axis-.09 mmStandard Deviation 0.23
.016 With Self-ligating BracketsLinear Change in Tooth Position From Baseline to 6 Weeks (Translation)Translation along the z-axis-.28 mmStandard Deviation 0.47
.016 With Self-ligating BracketsLinear Change in Tooth Position From Baseline to 6 Weeks (Translation)Translation along the y-axis.06 mmStandard Deviation 0.34

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026