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Analysis of Orthodontic Tooth Movement Using 3D Imaging

Primary Purpose

Tooth Crowding, Dental Crowding, Malocclusion

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
.014"
.016"
Twin brackets
Self-ligating brackets
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Crowding focused on measuring archwire dimension, ligation method, bracket type

Eligibility Criteria

10 Years - 45 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • UNC-CH School of Dentistry
  • Selden Orthodontics

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

.014" with twin brackets

.016" with twin brackets

.014" with self-ligating brackets

.016" with self-ligating brackets

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
December 15, 2017
Last Updated
April 30, 2020
Sponsor
University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT03398798
Brief Title
Analysis of Orthodontic Tooth Movement Using 3D Imaging
Official Title
Analysis of Orthodontic Tooth Movement Using 3D Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
November 29, 2018 (Actual)
Study Completion Date
November 29, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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: To analyze the effect of wire dimension (.014" vs. .016") and time-course (first six weeks or second six weeks) on Stage I treatment To correlate clinical tooth movements with bench data for four types of malalignment In-out Rotation Tip Vertical step 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Crowding, Dental Crowding, Malocclusion
Keywords
archwire dimension, ligation method, bracket type

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderOutcomes 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).
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
.014" with twin brackets
Arm Type
Active Comparator
Arm Description
.014" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia Metal Twin brackets.
Arm Title
.016" with twin brackets
Arm Type
Active Comparator
Arm Description
.016" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia Metal Twin brackets.
Arm Title
.014" with self-ligating brackets
Arm Type
Active Comparator
Arm Description
.014" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia SL (self-ligating) brackets.
Arm Title
.016" with self-ligating brackets
Arm Type
Active Comparator
Arm Description
.016" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia SL (self-ligating) brackets.
Intervention Type
Device
Intervention Name(s)
.014"
Intervention Description
.014" CuNiTi orthodontic arch wire
Intervention Type
Device
Intervention Name(s)
.016"
Intervention Description
.016" CuNiTi orthodontic arch wire
Intervention Type
Device
Intervention Name(s)
Twin brackets
Intervention Description
Ormco Insignia Metal Twin brackets
Intervention Type
Device
Intervention Name(s)
Self-ligating brackets
Intervention Description
Ormco Insignia SL brackets
Primary Outcome Measure Information:
Title
Change in Little's Index From Baseline to 6 Weeks
Description
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
Title
Change in Little's Index From 6 Weeks to 12 Weeks
Description
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
Secondary Outcome Measure Information:
Title
Linear Change in Tooth Position From Baseline to 6 Weeks (Translation)
Description
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
Title
Linear Change in Tooth Position From 6 Weeks to 12 Weeks (Translation)
Description
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
Title
Angular Change in Tooth Position From Baseline to 6 Weeks (Rotation)
Description
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
Title
Angular Change in Tooth Position From 6 Weeks to 12 Weeks (Rotation)
Description
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
Title
Correlation Between Degrees of Malalignment and Rate of Tooth Movement
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ching-Chang Ko, DDS, PhD
Organizational Affiliation
UNC-CH
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC-CH School of Dentistry
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Selden Orthodontics
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Analysis of Orthodontic Tooth Movement Using 3D Imaging

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