Orthodontic Archwire Effectiveness Trial (ArchWireRaCE)

• ClinicalTrials.gov Identifier: NCT02659813
• Recruitment Status: Active, not recruiting
• First Posted: January 20, 2016
• Last Update Posted: December 9, 2020
• Sponsor: University of Dundee
• Collaborator: Ormco Corporation
• Information provided by (Responsible Party): David Bearn, University of Dundee

Tracking Information

• First Submitted Date: January 14, 2016
• First Posted Date: January 20, 2016
• Last Update Posted Date: December 9, 2020
• Actual Study Start Date: October 2016
• Actual Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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 (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: Orthodontic Archwire Effectiveness Trial
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Malocclusion

Intervention

Device: Orthodontic archwire

Archwire used to align teeth in an orthodontic fixed brace

Other Names:

• Firewire
• Copper Nickel Titanium

Study Arms

• 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: January 19, 2016): 64
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 2021
• Actual Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02659813
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: David Bearn, University of Dundee
• Study Sponsor: University of Dundee
• Collaborators: Ormco Corporation

Investigators

• Principal Investigator: David R Bearn, BDS, PhD; University of Dundee

• PRS Account: University of Dundee
• Verification Date: December 2020