Analysis of Orthodontic Tooth Movement Using 3D Imaging

Analysis of Orthodontic Tooth Movement Using 3D Imaging



Sponsors


Source

University of North Carolina, Chapel Hill

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

Yes

Is Unapproved Device

No


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.

Overall Status

Recruiting

Start Date

2018-02-19

Completion Date

2018-12-01

Primary Completion Date

2018-12-01

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Change in Little's Index from baseline to 6 weeks
Baseline and 6 weeks
Change in Little's Index from 6 weeks to 12 weeks
6 weeks and 12 weeks

Secondary Outcome

Measure

Time Frame

Linear change in tooth position from baseline to 6 weeks (translation)
Baseline and 6 weeks
Linear change in tooth position from 6 weeks to 12 weeks (translation)
6 weeks and 12 weeks
Angular change in tooth position from baseline to 6 weeks (rotation)
Baseline and 6 weeks
Angular change in tooth position from 6 weeks to 12 weeks (rotation)
6 weeks and 12 weeks

Enrollment

80

Conditions


Intervention

Intervention Type

Device

Intervention Name


Description

.014" CuNiTi orthodontic arch wire

Arm Group Label

.014" with twin brackets

.014" with self-ligating brackets



Intervention Type

Device

Intervention Name


Description

.016" CuNiTi orthodontic arch wire

Arm Group Label

.016" with twin brackets

.016" with self-ligating brackets



Intervention Type

Device

Intervention Name


Description

Ormco Insignia Metal Twin brackets

Arm Group Label

.014" with twin brackets

.016" with twin brackets



Intervention Type

Device

Intervention Name


Description

Ormco Insignia SL brackets

Arm Group Label

.014" with self-ligating brackets

.016" with self-ligating brackets




Eligibility

Criteria

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)

Gender

All

Minimum Age

10 Years

Maximum Age

45 Years

Healthy Volunteers

Accepts Healthy Volunteers


Overall Official

Last Name

Role

Affiliation

Ching-Chang Ko, DDS, PhD
Principal Investigator
UNC-CH

Overall Contact

Last Name

Ching-Chang Ko, DDS, PhD

Phone

919-537-3763

Email



Location

Facility

Status

Contact

UNC-CH School of Dentistry
Chapel Hill North Carolina 27599 United States
Recruiting
Last Name: Ching-Chang Ko, DDS, PhD
Phone: 919-537-3763
Email: [email protected]
Selden Orthodontics
Huntersville North Carolina 28078 United States
Recruiting
Last Name: Robert Selden, DDS, MS
Phone: 704-728-4266
Email: [email protected]

Location Countries

Country

United States


Verification Date

2018-04-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Sponsor


Keywords


Has Expanded Access

No

Condition Browse


Number Of Arms

4

Arm Group

Arm Group Label

.014" with twin brackets

Arm Group Type

Active Comparator

Description

.014" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia Metal Twin brackets.


Arm Group Label

.016" with twin brackets

Arm Group Type

Active Comparator

Description

.016" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia Metal Twin brackets.


Arm Group Label

.014" with self-ligating brackets

Arm Group Type

Active Comparator

Description

.014" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia SL (self-ligating) brackets.


Arm Group Label

.016" with self-ligating brackets

Arm Group Type

Active Comparator

Description

.016" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia SL (self-ligating) brackets.



Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

Christian Piers, DDS, MFA

Phone

616-403-2576

Email



Patient Data

Sharing Ipd

No


Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Intervention Model Description

There will be four different groups in this study, each consisting of 20 patients.
In the twin bracket cohort, 20 patients will be treated with .014" dimension wire, and 20 patients will be treated with .016" dimension wire.
In the self-ligating bracket cohort, 20 patients will be treated with .014" dimension wire, and 20 patients will be treated with .016" dimension wire.

Primary Purpose

Treatment

Masking

Triple (Participant, Care Provider, 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).


Study First Submitted

December 15, 2017

Study First Submitted Qc

January 6, 2018

Study First Posted

January 12, 2018

Last Update Submitted

April 25, 2018

Last Update Submitted Qc

April 25, 2018

Last Update Posted

April 27, 2018


ClinicalTrials.gov processed this data on August 31, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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