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Analysis of Orthodontic Tooth Movement Using 3D Imaging

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ClinicalTrials.gov Identifier: NCT03398798
Recruitment Status : Not yet recruiting
First Posted : January 12, 2018
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Tooth Crowding Dental Crowding Malocclusion Device: .014" Device: .016" Device: Twin brackets Device: Self-ligating brackets

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

There will be four different groups in this study, each consisting of 20 patients.

In the twin bracket cohort, 20 patients will be treated with .014" dimension wire, and 20 patients will be treated with .016" dimension wire.

In the self-ligating bracket cohort, 20 patients will be treated with .014" dimension wire, and 20 patients will be treated with .016" dimension wire.

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).

Primary Purpose: Treatment
Official Title: Analysis of Orthodontic Tooth Movement Using 3D Imaging
Anticipated Study Start Date : January 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018
Arms and Interventions

Arm Intervention/treatment
Active Comparator: .014" with twin brackets
.014" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia Metal Twin brackets.
Device: .014"
.014" CuNiTi orthodontic arch wire
Device: Twin brackets
Ormco Insignia Metal Twin brackets
Active Comparator: .016" with twin brackets
.016" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia Metal Twin brackets.
Device: .016"
.016" CuNiTi orthodontic arch wire
Device: Twin brackets
Ormco Insignia Metal Twin brackets
Active Comparator: .014" with self-ligating brackets
.014" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia SL (self-ligating) brackets.
Device: .014"
.014" CuNiTi orthodontic arch wire
Device: Self-ligating brackets
Ormco Insignia SL brackets
Active Comparator: .016" with self-ligating brackets
.016" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia SL (self-ligating) brackets.
Device: .016"
.016" CuNiTi orthodontic arch wire
Device: Self-ligating brackets
Ormco Insignia SL brackets


Outcome Measures

Primary Outcome Measures :
  1. 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).

  2. 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 Outcome Measures :
  1. Linear change in tooth position from baseline to 6 weeks (translation) [ Time Frame: Baseline and 6 weeks ]
    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.

  2. Linear change in tooth position from 6 weeks to 12 weeks (translation) [ Time Frame: 6 weeks and 12 weeks ]
    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.

  3. Angular change in tooth position from baseline to 6 weeks (rotation) [ Time Frame: Baseline and 6 weeks ]
    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.

  4. Angular change in tooth position from 6 weeks to 12 weeks (rotation) [ Time Frame: 6 weeks and 12 weeks ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03398798


Contacts
Contact: Ching-Chang Ko, DDS, PhD 919-537-3763 Ching-Chang_Ko@unc.edu
Contact: Christian Piers, DDS, MFA 616-403-2576 christian.piers@unc.edu

Locations
United States, North Carolina
UNC-CH School of Dentistry Not yet recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Ching-Chang Ko, DDS, PhD    919-537-3763    Ching-Chang_Ko@unc.edu   
Contact: Christian Piers, DDS, MFA    616-403-2576    christian.piers@unc.edu   
Selden Orthodontics Not yet recruiting
Huntersville, North Carolina, United States, 28078
Contact: Robert Selden, DDS, MS    704-728-4266    selden_ortho@hotmail.com   
Contact: Samantha Beck       jackandsamanthaplus2@yahoo.com   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Ching-Chang Ko, DDS, PhD UNC-CH
More Information

Responsible Party: Ching-Chang Ko, DDS, MS, PhD, Chair, Department of Orthodontics, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03398798     History of Changes
Other Study ID Numbers: 17-1446
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ching-Chang Ko, DDS, MS, PhD, University of North Carolina, Chapel Hill:
archwire dimension
ligation method
bracket type

Additional relevant MeSH terms:
Malocclusion
Tooth Diseases
Stomatognathic Diseases