Analysis of Orthodontic Tooth Movement Using 3D Imaging
Analysis of Orthodontic Tooth Movement Using 3D Imaging
Sponsors
Source
University of North Carolina, Chapel Hill
Oversight Info
Has Dmc
No
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
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.
(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.
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.
Overall Status
Not yet recruiting
Start Date
2018-01-01
Completion Date
2018-12-01
Primary Completion Date
2018-12-01
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Change in Little's Index from baseline to 6 weeks |
Baseline and 6 weeks |
|
Change in Little's Index from 6 weeks to 12 weeks |
6 weeks and 12 weeks |
Secondary Outcome
Measure |
Time Frame |
|
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 |
Enrollment
80
Conditions
Intervention
Intervention Type
Device
Intervention Name
Description
.014" CuNiTi orthodontic arch wire
Arm Group Label
.014" with twin brackets
.014" with self-ligating brackets
Intervention Type
Device
Intervention Name
Description
.016" CuNiTi orthodontic arch wire
Arm Group Label
.016" with twin brackets
.016" with self-ligating brackets
Intervention Type
Device
Intervention Name
Description
Ormco Insignia Metal Twin brackets
Arm Group Label
.014" with twin brackets
.016" with twin brackets
Intervention Type
Device
Intervention Name
Description
Ormco Insignia SL brackets
Arm Group Label
.014" with self-ligating brackets
.016" with self-ligating brackets
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)
- 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)
Gender
All
Minimum Age
10 Years
Maximum Age
45 Years
Healthy Volunteers
Accepts Healthy Volunteers
Overall Official
Last Name |
Role |
Affiliation |
|
Ching-Chang Ko, DDS, PhD |
Principal Investigator |
UNC-CH |
Overall Contact
Location
Facility |
Status |
Contact |
|
UNC-CH School of Dentistry Chapel Hill North Carolina 27599 United States |
Not yet recruiting | |
|
Selden Orthodontics Huntersville North Carolina 28078 United States |
Not yet recruiting |
Location Countries
Country
United States
Verification Date
2018-01-01
Lastchanged Date
2018-01-06
Firstreceived Date
2017-12-15
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
University of North Carolina, Chapel Hill
Investigator Full Name
Ching-Chang Ko, DDS, MS, PhD
Investigator Title
Chair, Department of Orthodontics
Keywords
Has Expanded Access
No
Condition Browse
Number Of Arms
4
Arm Group
Arm Group Label
.014" with twin brackets
Arm Group Type
Active Comparator
Description
.014" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia Metal Twin brackets.
Arm Group Label
.016" with twin brackets
Arm Group Type
Active Comparator
Description
.016" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia Metal Twin brackets.
Arm Group Label
.014" with self-ligating brackets
Arm Group Type
Active Comparator
Description
.014" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia SL (self-ligating) brackets.
Arm Group Label
.016" with self-ligating brackets
Arm Group Type
Active Comparator
Description
.016" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia SL (self-ligating) brackets.
Firstreceived Results Date
N/A
Overall Contact Backup
Firstreceived Results Disposition Date
N/A
Study Design Info
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.
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.
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).
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).
Study First Submitted
December 15, 2017
Study First Submitted Qc
January 6, 2018
Study First Posted
January 12, 2018
Last Update Submitted
January 6, 2018
Last Update Submitted Qc
January 6, 2018
Last Update Posted
January 12, 2018
ClinicalTrials.gov processed this data on January 12, 2018
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.