Orthodontic Archwire Effectiveness Trial

Malocclusion Clinical Trial

— ArchWireRaCE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02659813
• Other study ID #: 2015DE11
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: August 17, 2021

Study information

• Verified date: October 2021
• Source: University of Dundee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: August 17, 2021
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malocclusion

Intervention

Device:
• Orthodontic archwire
Archwire used to align teeth in an orthodontic fixed brace

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Dundee	Ormco Corporation

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain assessed by Visual Analogue Scale	Visual Analogue Scale pain score after archwire placed	Initial six months of treatment
Secondary	Tooth Root Resorption assessed on panoramic radiograph using method of Pandis et al (2008)	Damage to tooth root during tooth movement	18 months
Secondary	Patient experience assessed by Questionnaire	Questionnaire of patient experiences of braces	Initial six months of treatment