MalocclusionNCT02311491
Nano-Crystalline Ceramic Coating of Orthodontic Archwires
A study testing Ceramic coated orthodontic archwire in people with Malocclusion, run by University of North Carolina, Chapel Hill.
Trial summary
Purpose: The project aims to assess if hard ceramic coatings on orthodontic archwires will reduce the sliding resistance of archwires in the brackets during orthodontic treatment procedures. Participants: Up to 80 subjects will be recruited for this study. Read more about this study
- Who is it for?
- Ages 10 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Malocclusion
- What is being tested?
- Ceramic coated orthodontic archwire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 or second stage of active treatment at the University of North Carolina graduate orthodontic clinic
- Specific inclusion criteria for 1st order tooth movement:
- Non-extraction treatment in mandible
- Mandibular Little Index greater than or equal to 5 mm
- Presence of all permanent anterior teeth
- Age 10-45 years
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- Consent to participate in the study
- Specific inclusion criteria for 2nd order tooth movement:
- Space closure treatment need greater than or equal to 3 mm (extraction and/or non-extraction patients)
- Space closure being carried out via sliding mechanics using power chains, spring coils, or interarch elastics
- Age 10-45 years
- Consent to participate in the study
Who cannot join
- Specific exclusion criteria for 1st order tooth movement:
- Systemic diseases such as diabetes, hypertension, temporomandibular disorders (TMD), craniofacial syndrome, etc.
- 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 lower anterior teeth greater than 4 mm
- Specific exclusion criteria for 2nd order tooth movement:
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- Systemic diseases such as diabetes, hypertension, TMD, craniofacial syndrome, etc.
- Space closure being carried out via closing loops
- Periodontal pocketing greater than 4 mm
About this study
Official title: Nano-Crystalline Ceramic Coating for the Reduction of Sliding Resistance of Orthodontic Archwires
Purpose: The project aims to assess if hard ceramic coatings on orthodontic archwires will reduce the sliding resistance of archwires in the brackets during orthodontic treatment procedures.
Participants: Up to 80 subjects will be recruited for this study. Subjects between 10 years of age and 45 years old will be otherwise healthy subjects previously diagnosed with malocclusion.
Procedures (methods): Each subject will receive an experimental (coated) or a regular (uncoated control) orthodontic archwire (AW) for a 3-month treatment. The 3D digital images of each subject's dentition will be recorded three times at 0-, 6- and 12-week visits. The AW will be removed and retrieved after the 3-month trial.
Read the detailed description
In this trial, nano-crystalline ceramics will be applied to the surface of orthodontic archwires using ion beam assisted deposition to reduce sliding resistance. Excessive sliding resistance works against tooth motion as the bracket slides along the wire into a new position. These ceramic coatings will produce more predictable outcomes, requiring less force and shorter treatment time. A limited clinical trial will be conducted to demonstrate these effects.
The aim of this project is to assess the clinical efficacy of the new archwires in Stage 1 (leveling and aligning) and Stage 2 (space closure) of orthodontic treatment using a twin bracket. The working hypothesis is that reduction of sliding resistance in bracket-wire interfaces will allow effective tooth movement in leveling, aligning, and sliding, while minimizing unwanted tooth movement such as lateral (mesio-distal direction) movement due to friction. 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. These patients will be comprised of a treatment group (coated) and a control group (uncoated) of 20 each in Stage 1 and Stage 2 treatment.
A successful program will demonstrate a clinically significant increase in the amount and rate-of-change of tooth movement in leveling, aligning, and sliding teeth.
- Conditions
- Malocclusion
- Being tested
- Ceramic coated orthodontic archwire
- Keywords
- nano crystalline, archwire
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceramic coated orthodontic archwireDevice
Hard ceramic coatings will reduce the sliding resistance of archwires in their brackets during orthodontic treatment procedures. The new coated archwire is expected to reduce treatment time.
| Study group | Role | What they receive |
|---|---|---|
| Ceramic Coated Orthodontic Archwire | Experimental | Ceramic coated orthodontic archwires will be evaluated in a limited clinical study at the university of North Carolina to test their efficacy in early and intermediate stages of tooth straightening in orthodontic patients. Receives: Device: Ceramic coated orthodontic archwire |
| Control | No intervention | The patients will receive the ordinary archwires. There is no intervention to the standard treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective tooth movement in translation
Clinical linear measurements (mm) in x-, y-, and z-translation at three time points (0-, 6-, and 12-weeks). A repeated measurement ANOVA model for the continuous clinical outcomes will be considered to test the proposed hypotheses.
Measured: 12 weeks
Effective tooth movement in rotation
Clinical angular measurements (degree) in x-, y-, and z-rotation at three time points (0-, 6-, and 12-weeks). A repeated measurement ANOVA model for the continuous clinical outcomes will be considered to test the proposed hypotheses.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startDec 2016
- Primary completionDec 2016 (estimated)
- Study completionAug 2017 (estimated)
Why it stopped: Funding terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalocclusionStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- N2 Biomedical LLC
- Responsible party
- Sponsor
- Investigators
- Ching-Chang Ko, DDS, PhD, Principal investigator, UNC-CH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02311491
- Sponsor's protocol ID
- 13-0924
- Status last verified
- Aug 2017
- First submitted
- 4 Dec 2014
- Last updated
- 28 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nano-Crystalline Ceramic Coating for the Reduction of Sliding Resistance of Orthodontic Archwires
- ClinicalTrials.gov ID
- NCT02311491
- Acronym / sponsor ID
- 13-0924
- Conditions
- Malocclusion
- Keywords
- nano crystalline, archwire
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding terminated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- N2 Biomedical LLC
- Study start
- Dec 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 8 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: The project aims to assess if hard ceramic coatings on orthodontic archwires will reduce the sliding resistance of archwires in the brackets during orthodontic treatment procedures.
Participants: Up to 80 subjects will be recruited for this study. Subjects between 10 years of age and 45 years old will be otherwise healthy subjects previously diagnosed with malocclusion.
Procedures (methods): Each subject will receive an experimental (coated) or a regular (uncoated control) orthodontic archwire (AW) for a 3-month treatment. The 3D digital images of each subject's dentition will be recorded three times at 0-, 6- and 12-week visits. The AW will be removed and retrieved after the 3-month trial.
Detailed description
In this trial, nano-crystalline ceramics will be applied to the surface of orthodontic archwires using ion beam assisted deposition to reduce sliding resistance. Excessive sliding resistance works against tooth motion as the bracket slides along the wire into a new position. These ceramic coatings will produce more predictable outcomes, requiring less force and shorter treatment time. A limited clinical trial will be conducted to demonstrate these effects.
The aim of this project is to assess the clinical efficacy of the new archwires in Stage 1 (leveling and aligning) and Stage 2 (space closure) of orthodontic treatment using a twin bracket. The working hypothesis is that reduction of sliding resistance in bracket-wire interfaces will allow effective tooth movement in leveling, aligning, and sliding, while minimizing unwanted tooth movement such as lateral (mesio-distal direction) movement due to friction. 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. These patients will be comprised of a treatment group (coated) and a control group (uncoated) of 20 each in Stage 1 and Stage 2 treatment.
A successful program will demonstrate a clinically significant increase in the amount and rate-of-change of tooth movement in leveling, aligning, and sliding teeth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ceramic Coated Orthodontic Archwire | Experimental | Device: Ceramic coated orthodontic archwireCeramic coated orthodontic archwires will be evaluated in a limited clinical study at the university of North Carolina to test their efficacy in early and intermediate stages of tooth straightening in orthodontic patients. |
| Control | No intervention | –The patients will receive the ordinary archwires. There is no intervention to the standard treatment. |
Who may qualify
- Ages
- 10 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- In the initial or second stage of active treatment at the University of North Carolina graduate orthodontic clinic
- Non-extraction treatment in mandible
- Mandibular Little Index greater than or equal to 5 mm
- Presence of all permanent anterior teeth
- Age 10-45 years
Key exclusion criteria (9 listed)
- Systemic diseases such as diabetes, hypertension, temporomandibular disorders (TMD), craniofacial syndrome, etc.
- 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 lower anterior teeth greater than 4 mm
- Systemic diseases such as diabetes, hypertension, TMD, craniofacial syndrome, etc.
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 |
|---|---|---|
| Ceramic coated orthodontic archwireHard ceramic coatings will reduce the sliding resistance of archwires in their brackets during orthodontic treatment procedures. The new coated archwire is expected to reduce treatment time. | Device | Ceramic Coated Orthodontic Archwire |
Primary outcome
Effective tooth movement in translation
Time frame: 12 weeks
Clinical linear measurements (mm) in x-, y-, and z-translation at three time points (0-, 6-, and 12-weeks). A repeated measurement ANOVA model for the continuous clinical outcomes will be considered to test the proposed hypotheses.
Effective tooth movement in rotation
Time frame: 12 weeks
Clinical angular measurements (degree) in x-, y-, and z-rotation at three time points (0-, 6-, and 12-weeks). A repeated measurement ANOVA model for the continuous clinical outcomes will be considered to test the proposed hypotheses.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2017.
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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
Questions about this trial
What is this clinical trial studying?
A study testing Ceramic coated orthodontic archwire in people with Malocclusion, run by University of North Carolina, Chapel Hill.
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 12 inclusion and 9 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: withdrawn, as of the sponsor's last update on 28 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Effective tooth movement in translation (time frame: 12 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 28 Aug 2017.