Tooth CrowdingNCT03398798
Analysis of Orthodontic Tooth Movement Using 3D Imaging
A study testing .014", .016" and Twin brackets in people with Tooth Crowding and Dental Crowding, run by University of North Carolina, Chapel Hill at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Crowding, Dental Crowding, Malocclusion
- What is being tested?
- .014", .016" and Twin brackets
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Jan 2018to 29 Nov 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UNC-CH School of Dentistry
Chapel Hill, North Carolina, 27599
Selden Orthodontics
Huntersville, North Carolina, 28078
About this study
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.
Read the 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:
- To analyze the effect of wire dimension (.014" vs. .016") and time-course (first six weeks or second six weeks) on Stage I treatment
- To correlate clinical tooth movements with bench data for four types of malalignment
- In-out
- Rotation
- Tip
- Vertical step
- 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.
- Conditions
- Tooth Crowding, Dental Crowding, Malocclusion
- Being tested
- .014", .016", Twin brackets, Self-ligating brackets
- Keywords
- archwire dimension, ligation method, bracket type
- Medical subject headings
- Malocclusion, Crowding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
.014"Device
.014" CuNiTi orthodontic arch wire
.016"Device
.016" CuNiTi orthodontic arch wire
Twin bracketsDevice
Ormco Insignia Metal Twin brackets
Self-ligating bracketsDevice
Ormco Insignia SL brackets
| Study group | Role | What they receive |
|---|---|---|
| .014" with twin brackets | Active comparator | .014" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia Metal Twin brackets. Receives: Device: .014"; Device: Twin brackets |
| .016" with twin brackets | Active comparator | .016" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia Metal Twin brackets. Receives: Device: .016"; Device: Twin brackets |
| .014" with self-ligating brackets | Active comparator | .014" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia SL (self-ligating) brackets. Receives: Device: .014"; Device: Self-ligating brackets |
| .016" with self-ligating brackets | Active comparator | .016" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia SL (self-ligating) brackets. Receives: Device: .016"; Device: Self-ligating brackets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and 6 weeks
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).
Measured: 6 weeks and 12 weeks
Secondary outcomes (5)
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.
Measured: Baseline and 6 weeks
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.
Measured: 6 weeks and 12 weeks
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.
Measured: Baseline and 6 weeks
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.
Measured: 6 weeks and 12 weeks
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.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start15 Jan 2018
- Primary completion29 Nov 2018
- Study completion29 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tooth CrowdingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be four different groups in this study, with each planned to consist of 20 patients (40 dental arches). In the twin bracket cohort, 40 dental arches are planned to be treated with .014" dimension wire, and 40 dental arches are planned to be treated with .016" dimension wire. In the self-ligating bracket cohort, 40 dental arches are planned to be treated with .014" dimension wire, and 40 dental arches are planned to be treated with .016" dimension wire.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ching-Chang Ko, DDS, PhD, Principal investigator, UNC-CH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03398798
- Sponsor's protocol ID
- 17-1446
- Status last verified
- Apr 2020
- First submitted
- 15 Dec 2017
- Last updated
- 1 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Orthodontic Tooth Movement Using 3D Imaging
- ClinicalTrials.gov ID
- NCT03398798
- Acronym / sponsor ID
- 17-1446
- Conditions
- Tooth Crowding, Dental Crowding, Malocclusion
- Keywords
- archwire dimension, ligation method, bracket type
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 29 Nov 2018 (actual)
- Study completion
- 29 Nov 2018 (actual)
- First posted
- 12 Jan 2018 (actual)
- Results
- Posted 1 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To analyze the effect of wire dimension (.014" vs. .016") and time-course (first six weeks or second six weeks) on Stage I treatment
- To correlate clinical tooth movements with bench data for four types of malalignment
- In-out
- Rotation
- Tip
- Vertical step
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
- Model description
- There will be four different groups in this study, with each planned to consist of 20 patients (40 dental arches). In the twin bracket cohort, 40 dental arches are planned to be treated with .014" dimension wire, and 40 dental arches are planned to be treated with .016" dimension wire. In the self-ligating bracket cohort, 40 dental arches are planned to be treated with .014" dimension wire, and 40 dental arches are planned to be treated with .016" dimension wire.
| Arm | Type | Receives |
|---|---|---|
| .014" with twin brackets | Active comparator | Device: .014", Device: Twin brackets.014" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia Metal Twin brackets. |
| .016" with twin brackets | Active comparator | Device: .016", Device: Twin brackets.016" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia Metal Twin brackets. |
| .014" with self-ligating brackets | Active comparator | Device: .014", Device: Self-ligating brackets.014" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia SL (self-ligating) brackets. |
| .016" with self-ligating brackets | Active comparator | Device: .016", Device: Self-ligating brackets.016" dimension CuNiTi orthodontic arch wires and .022" slot Ormco Insignia SL (self-ligating) brackets. |
Who may qualify
- Ages
- 10 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| .014".014" CuNiTi orthodontic arch wire | Device | .014" with self-ligating brackets, .014" with twin brackets |
| .016".016" CuNiTi orthodontic arch wire | Device | .016" with self-ligating brackets, .016" with twin brackets |
| Twin bracketsOrmco Insignia Metal Twin brackets | Device | .014" with twin brackets, .016" with twin brackets |
| Self-ligating bracketsOrmco Insignia SL brackets | Device | .014" with self-ligating brackets, .016" with self-ligating brackets |
Primary outcome
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).
5 secondary outcomes
Linear Change in Tooth Position From Baseline to 6 Weeks (Translation)
Time frame: Baseline and 6 weeks
Linear Change in Tooth Position From 6 Weeks to 12 Weeks (Translation)
Time frame: 6 weeks and 12 weeks
Angular Change in Tooth Position From Baseline to 6 Weeks (Rotation)
Time frame: Baseline and 6 weeks
Angular Change in Tooth Position From 6 Weeks to 12 Weeks (Rotation)
Time frame: 6 weeks and 12 weeks
Correlation Between Degrees of Malalignment and Rate of Tooth Movement
Time frame: Baseline and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ching-Chang Ko, DDS, PhD principal investigator
UNC-CH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing .014", .016" and Twin brackets in people with Tooth Crowding and Dental Crowding, run by University of North Carolina, Chapel Hill at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Little's Index From Baseline to 6 Weeks (time frame: Baseline and 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2020.