N/A
N=36
Analysis of Orthodontic Tooth Movement Using 3D Imaging
Tooth Crowding · Dental Crowding · Malocclusion
Bottom Line
View on ClinicalTrials.gov: NCT03398798 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
May 2020
Primary outcome: Primary: Change in Little's Index From Baseline to 6 Weeks — -2.5; -2.9; -2.3; -2.6 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- .014" (Device); .016" (Device); Twin brackets (Device); Self-ligating brackets (Device)
- Age
- Pediatric, Adult · 10+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Little's Index From Baseline to 6 Weeks |
-2.5; -2.9; -2.3; -2.6 | — |
| PRIMARY Change in Little's Index From 6 Weeks to 12 Weeks |
-0.8; -0.9; -0.2; -0.4 | — |
| SECONDARY Linear Change in Tooth Position From Baseline to 6 Weeks (Translation) |
.03; -.05; -.14; -.09; .05; .03 | — |
| SECONDARY Linear Change in Tooth Position From 6 Weeks to 12 Weeks (Translation) |
.05; .05; .01; .03; .03; .03 | — |
| SECONDARY Angular Change in Tooth Position From Baseline to 6 Weeks (Rotation) |
1.95; 1.52; 1.97; 1.91; 1.37; .99 | — |
| SECONDARY Angular Change in Tooth Position From 6 Weeks to 12 Weeks (Rotation) |
.82; 1.07; .66; .40; .86; .39 | — |
| SECONDARY Correlation Between Degrees of Malalignment and Rate of Tooth Movement |
— | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT03398798). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.