Malocclusion Clinical Trial
Official title:
Analysis of Orthodontic Tooth Movement Using 3D Imaging
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.
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.
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