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ArchWireRaCE: Orthodontic Archwire Effectiveness Trial

Sponsor
University of Dundee (Other)
Overall Status
Completed
CT.gov ID
NCT02659813
Collaborator
Ormco Corporation (Industry)
64
Enrollment
2
Arms
58.5
Actual Duration (Months)

Study Details

Study Description

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
  • Device: Orthodontic archwire
 N/A

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

Study Type:
Interventional
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 :
Oct 1, 2016
Actual Primary Completion Date :
Apr 1, 2019
Actual Study Completion Date :
Aug 17, 2021

Arms and Interventions

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

    Primary Outcome Measures

    1. Rate of tooth movement [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 [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) [18 months]

      Damage to tooth root during tooth movement

    3. Patient experience assessed by Questionnaire [Initial six months of treatment]

      Questionnaire of patient experiences of braces

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Dundee
    • Ormco Corporation

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of Dundee
    ClinicalTrials.gov Identifier:
    NCT02659813
    Other Study ID Numbers:
    • 2015DE11
    First Posted:
    Jan 20, 2016
    Last Update Posted:
    Oct 18, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Dundee
    Orthodontic wires
    Additional relevant MeSH terms:
    Malocclusion
    Copper
    Nickel

    Study Results

    No Results Posted as of Oct 18, 2021