MalocclusionArchWireRaCENCT02659813
Orthodontic Archwire Effectiveness Trial
A study testing Orthodontic archwire in people with Malocclusion, run by University of Dundee.
Trial summary
This study protocol is for a randomised clinical trial which aims to test two materials used as orthodontic archwire to compare FireWire archwires to Copper Nickel Titanium (CNiTi) archwires. Both professional and patient related outcome measures are to be used to fully evaluate performance. Read more about this study
- Who is it for?
- Ages 12 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
- 64 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to 17 Aug 2021
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 12 years of age or older
- Class 1 Incisor relationship (British Standards Institute Classification)
- Labial segment crowding in upper and / or lower arch >4mm
- Little's Irregularity Index in upper and / or lower arch >4mm
- Eligible for NHS orthodontic treatment
- Planned non-extraction upper and lower fixed appliance orthodontic treatment
Who cannot join
- Previous fixed appliance orthodontic treatment
- Previous functional appliance treatment
- Planned use of fixed auxiliary appliances (e.g. quadhelix, Trans Palatal Arch)
- Cleft lip and palate or other craniofacial anomalies
- Hypodontia (excluding third molars), or missing teeth due to previous extraction
- Abnormal root morphology on pre-treatment radiographs
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- Confirmed history of nickel allergy
- A medical history resulting in them taking analgesics for a chronic condition
- Limited mouth opening or other contra-indication to intra-oral scanning
About this study
Official title: ArchWire-RaCE: Orthodontic Archwires: a Randomised Clinical Trial of Effectiveness
This study protocol is for a randomised clinical trial which aims to test two materials used as orthodontic archwire to compare FireWire archwires to Copper Nickel Titanium (CNiTi) archwires. Both professional and patient related outcome measures are to be used to fully evaluate performance.
Read the detailed description
This is a randomised clinical trial of Firewire and CNiTi as orthodontic aligning archwires. A two group single blind parallel multicentre study design in a National Health Service primary care setting in England will be used.
Patients will be recruited from those attending the practices for orthodontic treatment that meet the inclusion and exclusion criteria. Online randomisation will allocate to one of the two groups, stratified by centre and age group (adolescent / adult).
Sample size calculation indicates a total sample size of 42, but allowing for dropouts and missing data the investigators will recruit 64, 32 to each group.
Patients will be treated according to a strict clinical protocol including customised Damon Q fixed appliances and defined archwire sequence. Participants will be seen at initial 5 week intervals for data collection after new archwire placement, and otherwise at routine 10 week intervals.
Primary outcome data (rate of alignment) will be collected over the initial 10 weeks and secondary outcomes over the duration of the treatment (18 months approx).
- Conditions
- Malocclusion
- Being tested
- Orthodontic archwire
- Keywords
- Orthodontic wires
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthodontic archwireDevice
Also called Firewire, Copper Nickel Titanium
Archwire used to align teeth in an orthodontic fixed brace
| Study group | Role | What they receive |
|---|---|---|
| Firewire | Experimental | Experimental Group 1. Novel orthodontic archwire. Receives: Device: Orthodontic archwire |
| CNiTi | Experimental | Experimental Group 2. Current best available orthodontic archwire Receives: Device: Orthodontic archwire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of tooth movement
Rate teeth move in response to force from archwire measured in millimetres on digital dental models
Measured: Initial six months of treatment
Secondary outcomes (3)
Pain assessed by Visual Analogue Scale
Visual Analogue Scale pain score after archwire placed
Measured: Initial six months of treatment
Tooth Root Resorption assessed on panoramic radiograph using method of Pandis et al (2008)
Damage to tooth root during tooth movement
Measured: 18 months
Patient experience assessed by Questionnaire
Questionnaire of patient experiences of braces
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 posted20 Jan 2016 (estimated)
- Study startOct 2016
- Primary completionApr 2019
- Study completion17 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Collaborators
- Ormco Corporation
- Responsible party
- Sponsor
- Investigators
- David R Bearn, BDS, PhD, Principal investigator, University of Dundee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02659813
- Sponsor's protocol ID
- 2015DE11
- Acronym
- ArchWireRaCE
- Status last verified
- Oct 2021
- First submitted
- 14 Jan 2016
- Last updated
- 18 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pandis N, Nasika M, Polychronopoulou A, Eliades T. External apical root resorption in patients treated with conventional and self-ligating brackets. Am J Orthod Dentofacial Orthop. 2008 Nov;134(5):646-51. doi: 10.1016/j.ajodo.2007.01.032.
PubMed 18984396
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ArchWire-RaCE: Orthodontic Archwires: a Randomised Clinical Trial of Effectiveness
- ClinicalTrials.gov ID
- NCT02659813
- Acronym / sponsor ID
- ArchWireRaCE / 2015DE11
- Conditions
- Malocclusion
- Keywords
- Orthodontic wires
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Collaborators
- Ormco Corporation
- Study start
- Oct 2016 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- 17 Aug 2021 (actual)
- First posted
- 20 Jan 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.
This study protocol is for a randomised clinical trial which aims to test two materials used as orthodontic archwire to compare FireWire archwires to Copper Nickel Titanium (CNiTi) archwires. Both professional and patient related outcome measures are to be used to fully evaluate performance.
Detailed description
This is a randomised clinical trial of Firewire and CNiTi as orthodontic aligning archwires. A two group single blind parallel multicentre study design in a National Health Service primary care setting in England will be used.
Patients will be recruited from those attending the practices for orthodontic treatment that meet the inclusion and exclusion criteria. Online randomisation will allocate to one of the two groups, stratified by centre and age group (adolescent / adult).
Sample size calculation indicates a total sample size of 42, but allowing for dropouts and missing data the investigators will recruit 64, 32 to each group.
Patients will be treated according to a strict clinical protocol including customised Damon Q fixed appliances and defined archwire sequence. Participants will be seen at initial 5 week intervals for data collection after new archwire placement, and otherwise at routine 10 week intervals.
Primary outcome data (rate of alignment) will be collected over the initial 10 weeks and secondary outcomes over the duration of the treatment (18 months approx).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Firewire | Experimental | Device: Orthodontic archwireExperimental Group 1. Novel orthodontic archwire. |
| CNiTi | Experimental | Device: Orthodontic archwireExperimental Group 2. Current best available orthodontic archwire |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 12 years of age or older
- Class 1 Incisor relationship (British Standards Institute Classification)
- Labial segment crowding in upper and / or lower arch >4mm
- Little's Irregularity Index in upper and / or lower arch >4mm
- Eligible for NHS orthodontic treatment
Key exclusion criteria (9 listed)
- Previous fixed appliance orthodontic treatment
- Previous functional appliance treatment
- Planned use of fixed auxiliary appliances (e.g. quadhelix, Trans Palatal Arch)
- Cleft lip and palate or other craniofacial anomalies
- Hypodontia (excluding third molars), or missing teeth due to previous extraction
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: Firewire, Copper Nickel TitaniumArchwire used to align teeth in an orthodontic fixed brace | Device | CNiTi, Firewire |
Primary outcome
Rate of tooth movement
Time frame: Initial six months of treatment
Rate teeth move in response to force from archwire measured in millimetres on digital dental models
3 secondary outcomes
Pain assessed by Visual Analogue Scale
Time frame: Initial six months of treatment
Tooth Root Resorption assessed on panoramic radiograph using method of Pandis et al (2008)
Time frame: 18 months
Patient experience assessed by Questionnaire
Time frame: Initial six months of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2021.
- Background: PubMed 18984396Pandis N, Nasika M, Polychronopoulou A, Eliades T. External apical root resorption in patients treated with conventional and self-ligating brackets. Am J Orthod Dentofacial Orthop. 2008 Nov;134(5):646-51. doi: 10.1016/j.ajodo.2007.01.032.
- Individual participant dataSharing planned: No
Related trials for Malocclusion
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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.
David R Bearn, BDS, PhD principal investigator
University of Dundee
Questions about this trial
What is this clinical trial studying?
A study testing Orthodontic archwire in people with Malocclusion, run by University of Dundee.
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 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: finished, as of the sponsor's last update on 18 Oct 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of tooth movement (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?
On the ClinicalTrials.gov record for NCT02659813, which also lists 1 linked publication.
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 18 Oct 2021.