NCT02659813

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 20, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2021

Completed
Last Updated

October 18, 2021

Status Verified

October 1, 2021

Enrollment Period

2.5 years

First QC Date

January 14, 2016

Last Update Submit

October 15, 2021

Conditions

Malocclusion

Keywords

Orthodontic wires

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Pain assessed by Visual Analogue Scale

    Initial six months of treatment

  • Tooth Root Resorption assessed on panoramic radiograph using method of Pandis et al (2008)

    18 months

  • Patient experience assessed by Questionnaire

    Initial six months of treatment

Study Arms (2)

Firewire

EXPERIMENTAL

Experimental Group 1. Novel orthodontic archwire.

Device: Orthodontic archwire

CNiTi

EXPERIMENTAL

Experimental Group 2. Current best available orthodontic archwire

Device: Orthodontic archwire

Interventions

Orthodontic archwireDEVICE

Archwire used to align teeth in an orthodontic fixed brace

Also known as: Firewire, Copper Nickel Titanium
CNiTiFirewire

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 18984396BACKGROUND

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • David R Bearn, BDS, PhD

    University of Dundee

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2016

First Posted

January 20, 2016

Study Start

October 1, 2016

Primary Completion

April 1, 2019

Study Completion

August 17, 2021

Last Updated

October 18, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share