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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
Sponsor:
Collaborator:
Ormco Corporation
Information provided by (Responsible Party):
David Bearn, University of Dundee

Study Description
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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.

Condition or disease Intervention/treatment Phase
Malocclusion Device: Orthodontic archwire Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ArchWire-RaCE: Orthodontic Archwires: a Randomised Clinical Trial of Effectiveness
Actual Study Start Date : October 2016
Actual Primary Completion Date : April 2019
Estimated Study Completion Date : April 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Firewire
Experimental Group 1. Novel orthodontic archwire.
 Device: Orthodontic archwire
Archwire used to align teeth in an orthodontic fixed brace
Other Names:
  • Firewire
  • Copper Nickel Titanium
Experimental: CNiTi
Experimental Group 2. Current best available orthodontic archwire
 Device: Orthodontic archwire
Archwire used to align teeth in an orthodontic fixed brace
Other Names:
  • Firewire
  • Copper Nickel Titanium


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Pain assessed by Visual Analogue Scale [ Time Frame: Initial six months of treatment ]
    Visual Analogue Scale pain score after archwire placed

  2. Tooth Root Resorption assessed on panoramic radiograph using method of Pandis et al (2008) [ Time Frame: 18 months ]
    Damage to tooth root during tooth movement

  3. Patient experience assessed by Questionnaire [ Time Frame: Initial six months of treatment ]
    Questionnaire of patient experiences of braces


Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02659813


Sponsors and Collaborators
University of Dundee
Ormco Corporation
Investigators
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Principal Investigator: David R Bearn, BDS, PhD University of Dundee
More Information
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Publications:

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Responsible Party: David Bearn, Professor of Orthodontics, University of Dundee
ClinicalTrials.gov Identifier: NCT02659813    
Other Study ID Numbers: 2015DE11
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: December 9, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Bearn, University of Dundee:
Orthodontic wires
Additional relevant MeSH terms:
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Malocclusion
Tooth Diseases
Stomatognathic Diseases
Copper
Nickel
 Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs