Orthodontic Archwire Effectiveness Trial (ArchWireRaCE)

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

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.

Study Overview

• Status: Completed
• Conditions: Malocclusion
• Intervention / Treatment: Device: Orthodontic archwire

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
• Enrollment (Actual): 64
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Dundee
• Collaborators: Ormco Corporation
• Investigators: Principal Investigator: David R Bearn, BDS, PhD, University of Dundee

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): August 17, 2021

Study Registration Dates

• First Submitted: January 14, 2016
• First Submitted That Met QC Criteria: January 19, 2016
• First Posted (Estimate): January 20, 2016

Study Record Updates

• Last Update Posted (Actual): October 18, 2021
• Last Update Submitted That Met QC Criteria: October 15, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Orthodontic wires
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion; Physiological Effects of Drugs; Trace Elements; Micronutrients; Copper; Nickel
• Other Study ID Numbers: 2015DE11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No