Orthodontic Archwire Effectiveness Trial

Study Overview
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Brief Summary
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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
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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).

Official Title
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ArchWire-RaCE: Orthodontic Archwires: a Randomised Clinical Trial of Effectiveness

Conditions
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Malocclusion

Intervention / Treatment
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* Device: Orthodontic archwire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Firewire<br>Experimental Group 1. Novel orthodontic archwire. | Device: Orthodontic archwire<br>* Archwire used to align teeth in an orthodontic fixed brace<br>* Other names: Copper Nickel Titanium;|
| Experimental: CNiTi<br>Experimental Group 2. Current best available orthodontic archwire | Device: Orthodontic archwire<br>* Archwire used to align teeth in an orthodontic fixed brace<br>* Other names: Copper Nickel Titanium;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of tooth movement | Rate teeth move in response to force from archwire measured in millimetres on digital dental models | Initial six months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessed by Visual Analogue Scale | Visual Analogue Scale pain score after archwire placed | 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 | 18 months | 
| Patient experience assessed by Questionnaire | Questionnaire of patient experiences of braces | Initial six months of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Orthodontic wires