Analysis of Orthodontic Tooth Movement Using 3D Imaging
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 36
- Locations
- 4
- Primary Endpoint
- Change in Little's Index From Baseline to 6 Weeks
Study Overview
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:
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To analyze the effect of wire dimension (.014" vs. .016") and time-course (first six weeks or second six weeks) on Stage I treatment
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To correlate clinical tooth movements with bench data for four types of malalignment
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In-out
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Rotation
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Tip
-
Vertical step
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To analyze the effect of ligation method (twin vs. self-ligating) on Stage I treatment
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- 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).
Eligibility Criteria
- Ages
- 10 Years to 45 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Outcomes
Primary Outcomes
Change in Little's Index From Baseline to 6 Weeks
Time Frame: Baseline and 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
Time Frame: 6 weeks and 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 Outcomes
- 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)
- Correlation Between Degrees of Malalignment and Rate of Tooth Movement(Baseline and 12 weeks)