Malocclusion Clinical Trial
Official title:
Analysis of Orthodontic Tooth Movement Using 3D Imaging
Verified date | April 2020 |
Source | University of North Carolina, Chapel Hill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 36 |
Est. completion date | November 29, 2018 |
Est. primary completion date | November 29, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 10 Years to 45 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United States | UNC-CH School of Dentistry | Chapel Hill | North Carolina |
United States | Selden Orthodontics | Huntersville | North Carolina |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Little's Index From Baseline to 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). | Baseline and 6 weeks | |
Primary | Change in Little's Index From 6 Weeks to 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). | 6 weeks and 12 weeks | |
Secondary | Linear Change in Tooth Position From Baseline to 6 Weeks (Translation) | Clinical linear measurements (mm) in x-, y-, and z-translation will be measured at two time points (0 weeks and 6 weeks) to determine the linear (translational) change in tooth position during that time. | Baseline and 6 weeks | |
Secondary | Linear Change in Tooth Position From 6 Weeks to 12 Weeks (Translation) | Clinical linear measurements (mm) in x-, y-, and z-translation will be measured at two time points (6 weeks and 12 weeks) to determine the linear (translational) change in tooth position during that time. | 6 weeks and 12 weeks | |
Secondary | Angular Change in Tooth Position From Baseline to 6 Weeks (Rotation) | Clinical angular measurements (degree) in x-, y-, and z-rotation will be measured at two time points (0 weeks and 6 weeks) to determine the angular (rotational) change in tooth position during that time. | Baseline and 6 weeks | |
Secondary | Angular Change in Tooth Position From 6 Weeks to 12 Weeks (Rotation) | Clinical angular measurements (degree) in x-, y-, and z-rotation will be measured at two time points (6 weeks and 12 weeks) to determine the angular (rotational) change in tooth position during that time. | 6 weeks and 12 weeks | |
Secondary | Correlation Between Degrees of Malalignment and Rate of Tooth Movement | A repeated measure linear regression model conducted to evaluate any correlation between the degrees of malalignment and the rate of tooth movement. | Baseline and 12 weeks |
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