MalocclusionNCT02983084
Orthodontic Archwire Comparison Trial
A study testing Orthodontic archwire in people with Malocclusion, run by Ormco Corporation at 1 site in United States.
Trial summary
The purpose of this randomized clinical trial (RCT) is to compare traditional CuNiTi archwires and a recently marketed multiforce version of the same material for the initial alignment and leveling of dental arches, as well as the expression of EARR in adult orthodontic patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malocclusion
- What is being tested?
- Orthodontic archwire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2016to 31 Mar 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult >14yrs of age
- Amenable to treatment with metal brackets
- Crowding of 3-8mm in one or both arches (non-extraction treatment)
- Overbite >3mm
- Read and speak English without a translator
- Individuals in good general health at the discretion of the investigator(s)
Who cannot join
- Medical/Dental History (Hx):
- Documented metabolic disorder(s)
- Nickel allergy
- Bisphosphonate treatment
- Amelogenesis, dentinogenesis or osteogenesis imperfect
- Active caries or periodontal disease
- Root resorption (moderate to severe)
- Patients who are pregnant or breast feeding or plan to be pregnant during the study
Trial locations and contacts
1 site in 1 country.
United States1 site
IUSD Orthodontic Clinic
Indianapolis, Indiana, 46202
About this study
Official title: SmartWire Multiforce Archwire Clinical Trial
The purpose of this randomized clinical trial (RCT) is to compare traditional CuNiTi archwires and a recently marketed multiforce version of the same material for the initial alignment and leveling of dental arches, as well as the expression of EARR in adult orthodontic patients.
Read the detailed description
This is a randomized clinical trial utilizing multiforce and CuNiTi orthodontic archwires to align and level dental arches and compare their results. A three group double blind parallel single site study at IUSD will be used.
Patients that meet the inclusion and exclusion criteria will be recruited from the IUSD orthodontic clinic. The subjects will be randomly assigned to one of the three groups by the study statistician. Subjects, examiners providing subject treatment, and examiners measuring study outcomes will be blinded to treatment assignment.
Study population indicates a sample size of 105 subjects, each group containing 35 clinical subjects.
Patients will be treated with Ormco Titanium Orthos fixed appliances and defined archwire sequence according to a clinical protocol. During the six-month study period, subjects will be seen approximately every 4 (four) weeks for regular standard of care appointments that will include archwire monitoring, photography and questionnaire completions. Final study records will be taken at the end of the study period.
- Conditions
- Malocclusion
- Being tested
- Orthodontic archwire
- Keywords
- Orthodontic wires, Root resorption
- Medical subject headings
- Malocclusion, Root Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthodontic archwireDevice
Also called Multiforce CuNiTi, CuNiTi, Copper Nickel Titanium
Archwire used to align teeth in an orthodontic fixed appliance
| Study group | Role | What they receive |
|---|---|---|
| Multiforce | Experimental | Variable modulus version of a current orthodontic archwire Receives: Device: Orthodontic archwire |
| CuNiTi A | Active comparator | .016" current orthodontic archwire Receives: Device: Orthodontic archwire |
| CuNiTi B | Active comparator | 0.014" and 0.018" current orthodontic archwire sequence Receives: Device: Orthodontic archwire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alignment of dental arches
Tooth alignment rate in response to force from archwire measured in mm on dental models
Measured: Initial six months of treatment
Secondary outcomes (2)
Leveling of dental arches
Depth of the Curve of Spee (CoS): percent correction during the six month initial alignment
Measured: Initial six months of treatment
Expression of external apical root resorption (EARR)
Amount of root resorption in response to force from archwire calculated in 3D from the CBCT
Measured: Initial six months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study start1 Dec 2016
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Mar 2020 (estimated)
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.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ormco Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Indiana University
- Responsible party
- Sponsor
- Investigators
- Kelton T Stewart, DDS, MS, Principal investigator, Indiana Unversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983084
- Sponsor's protocol ID
- 1608063565
- Status last verified
- Jan 2019
- First submitted
- 29 Nov 2016
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SmartWire Multiforce Archwire Clinical Trial
- ClinicalTrials.gov ID
- NCT02983084
- Acronym / sponsor ID
- 1608063565
- Conditions
- Malocclusion
- Keywords
- Orthodontic wires, Root resorption
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Ormco CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Indiana University
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 6 Dec 2016 (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.
The purpose of this randomized clinical trial (RCT) is to compare traditional CuNiTi archwires and a recently marketed multiforce version of the same material for the initial alignment and leveling of dental arches, as well as the expression of EARR in adult orthodontic patients.
Detailed description
This is a randomized clinical trial utilizing multiforce and CuNiTi orthodontic archwires to align and level dental arches and compare their results. A three group double blind parallel single site study at IUSD will be used.
Patients that meet the inclusion and exclusion criteria will be recruited from the IUSD orthodontic clinic. The subjects will be randomly assigned to one of the three groups by the study statistician. Subjects, examiners providing subject treatment, and examiners measuring study outcomes will be blinded to treatment assignment.
Study population indicates a sample size of 105 subjects, each group containing 35 clinical subjects.
Patients will be treated with Ormco Titanium Orthos fixed appliances and defined archwire sequence according to a clinical protocol. During the six-month study period, subjects will be seen approximately every 4 (four) weeks for regular standard of care appointments that will include archwire monitoring, photography and questionnaire completions. Final study records will be taken at the end of the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Multiforce | Experimental | Device: Orthodontic archwireVariable modulus version of a current orthodontic archwire |
| CuNiTi A | Active comparator | Device: Orthodontic archwire.016" current orthodontic archwire |
| CuNiTi B | Active comparator | Device: Orthodontic archwire0.014" and 0.018" current orthodontic archwire sequence |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult >14yrs of age
- Amenable to treatment with metal brackets
- Crowding of 3-8mm in one or both arches (non-extraction treatment)
- Overbite >3mm
- Read and speak English without a translator
Key exclusion criteria (8 listed)
- Medical/Dental History (Hx):
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 |
|---|---|---|
| Orthodontic archwireAlso: Multiforce CuNiTi, CuNiTi, Copper Nickel TitaniumArchwire used to align teeth in an orthodontic fixed appliance | Device | CuNiTi A, CuNiTi B, Multiforce |
Primary outcome
Alignment of dental arches
Time frame: Initial six months of treatment
Tooth alignment rate in response to force from archwire measured in mm on dental models
2 secondary outcomes
Leveling of dental arches
Time frame: Initial six months of treatment
Expression of external apical root resorption (EARR)
Time frame: Initial six months of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- 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.
Kelton T Stewart, DDS, MS principal investigator
Indiana Unversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orthodontic archwire in people with Malocclusion, run by Ormco Corporation at 1 site 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 8 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: status not confirmed, as of the sponsor's last update on 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
Alignment of dental arches (time frame: Initial six months of treatment). 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 15 Jan 2019.