Skip to main content
OpenTrials
Completed

NCT Number: NCT02659813

Orthodontic Archwire Effectiveness Trial

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Malocclusion Stomatognathic Diseases Tooth Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Orthodontic archwire

Device

Archwire used to align teeth in an orthodontic fixed brace

Other names: Firewire, Copper Nickel Titanium

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Dundee

Other

Collaborators

  • Ormco Corporation

Registry information

Official study title

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

Acronym: ArchWireRaCE

Important dates

Study start
2016
Primary completion
2019
Study completion
2021
First posted
Jan 20, 2016
Registry last updated
Oct 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.