Orthodontic Archwire Effectiveness Trial (ArchWireRaCE)
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ClinicalTrials.gov Identifier: NCT02659813 |
Recruitment Status :
Active, not recruiting
First Posted : January 20, 2016
Last Update Posted : December 9, 2020
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Tracking Information | |||||
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First Submitted Date ICMJE | January 14, 2016 | ||||
First Posted Date ICMJE | January 20, 2016 | ||||
Last Update Posted Date | December 9, 2020 | ||||
Actual Study Start Date ICMJE | October 2016 | ||||
Actual Primary Completion Date | April 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Orthodontic Archwire Effectiveness Trial | ||||
Official Title ICMJE | ArchWire-RaCE: Orthodontic Archwires: a Randomised Clinical Trial of Effectiveness | ||||
Brief 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. | ||||
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). |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Malocclusion | ||||
Intervention ICMJE | Device: Orthodontic archwire
Archwire used to align teeth in an orthodontic fixed brace
Other Names:
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Study Arms ICMJE |
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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. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
64 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | April 2021 | ||||
Actual Primary Completion Date | April 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 12 Years and older (Child, Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Not Provided | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT02659813 | ||||
Other Study ID Numbers ICMJE | 2015DE11 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | David Bearn, University of Dundee | ||||
Study Sponsor ICMJE | University of Dundee | ||||
Collaborators ICMJE | Ormco Corporation | ||||
Investigators ICMJE |
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PRS Account | University of Dundee | ||||
Verification Date | December 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |