Clinical trial NCT03398798: Analysis of Orthodontic Tooth Movement Using 3D Imaging
Official title: Analysis of Orthodontic Tooth Movement Using 3D Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Crowding
Dental Crowding
Malocclusion
Keywords: archwire dimension
ligation method
bracket type
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2018-01-12
Enrollment: 36
Sex: ALL
Minimum age (years): 10
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change in Little's Index From Baseline to 6 Weeks
timeFrame: Baseline and 6 weeks
measure: Change in Little's Index From 6 Weeks to 12 Weeks
timeFrame: 6 weeks and 12 weeks
Secondary outcomes:
measure: Linear Change in Tooth Position From Baseline to 6 Weeks (Translation)
timeFrame: Baseline and 6 weeks
measure: Linear Change in Tooth Position From 6 Weeks to 12 Weeks (Translation)
timeFrame: 6 weeks and 12 weeks
measure: Angular Change in Tooth Position From Baseline to 6 Weeks (Rotation)
timeFrame: Baseline and 6 weeks
measure: Angular Change in Tooth Position From 6 Weeks to 12 Weeks (Rotation)
timeFrame: 6 weeks and 12 weeks
measure: Correlation Between Degrees of Malalignment and Rate of Tooth Movement
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC-CH School of Dentistry
state: North Carolina
city: Huntersville
country: United States
facility: Selden Orthodontics
state: North Carolina
Study officials:
affiliation: UNC-CH
name: Ching-Chang Ko, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: