Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
64 participants
INTERVENTIONAL
2016-10-31
2021-08-17
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Firewire
Experimental Group 1. Novel orthodontic archwire.
Orthodontic archwire
Archwire used to align teeth in an orthodontic fixed brace
CNiTi
Experimental Group 2. Current best available orthodontic archwire
Orthodontic archwire
Archwire used to align teeth in an orthodontic fixed brace
Interventions
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Orthodontic archwire
Archwire used to align teeth in an orthodontic fixed brace
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
12 Years
ALL
No
Sponsors
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Ormco Corporation
INDUSTRY
University of Dundee
OTHER
Responsible Party
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Principal Investigators
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David R Bearn, BDS, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Dundee
References
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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.
Other Identifiers
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2015DE11
Identifier Type: -
Identifier Source: org_study_id