NCT03398798

Analysis of Orthodontic Tooth Movement Using 3D Imaging

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 10 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Tooth Crowding
• Dental Crowding
• Malocclusion

Interventions

Type	Name	Description
DEVICE	.014"	.014" CuNiTi orthodontic arch wire
DEVICE	.016"	.016" CuNiTi orthodontic arch wire
DEVICE	Twin brackets	Ormco Insignia Metal Twin brackets
DEVICE	Self-ligating brackets	Ormco Insignia SL brackets

Timeline

• Start date: 2018-01-15
• Primary completion: 2018-11-29
• Completion: 2018-11-29
• First posted: 2018-01-12
• Last updated: 2020-05-01
• Results posted: 2020-05-01

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study