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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

Tracking Information
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
 (submitted: January 19, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2016)
  • Pain assessed by Visual Analogue Scale [ Time Frame: Initial six months of treatment ]
    Visual Analogue Scale pain score after archwire placed
  • 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
  • Patient experience assessed by Questionnaire [ Time Frame: Initial six months of treatment ]
    Questionnaire of patient experiences of braces
Original Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2016)
  • Pain assessed by Visual Analogue Scale [ Time Frame: Initial six months of treatment ]
    Visual Analogue Scale pain score after archwire placed
  • Tooth Root Resorption assessed on peripical radiograph using scale of Linge & Linge [ Time Frame: 18 months ]
    Damage to tooth root during tooth movement
  • Patient experience assessed by Questionnaire [ Time Frame: Initial six months of treatment ]
    Questionnaire of patient experiences of braces
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).

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
Condition  ICMJE Malocclusion
Intervention  ICMJE Device: Orthodontic archwire
Archwire used to align teeth in an orthodontic fixed brace
Other Names:
  • Firewire
  • Copper Nickel Titanium
Study Arms  ICMJE
  • Experimental: Firewire
    Experimental Group 1. Novel orthodontic archwire.
    Intervention: Device: Orthodontic archwire
  • Experimental: CNiTi
    Experimental Group 2. Current best available orthodontic archwire
    Intervention: Device: Orthodontic archwire
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.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 19, 2016)
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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party David Bearn, University of Dundee
Study Sponsor  ICMJE University of Dundee
Collaborators  ICMJE Ormco Corporation
Investigators  ICMJE
Principal Investigator: David R Bearn, BDS, PhD University of Dundee
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