Orthodontic Archwire Effectiveness Trial

Not Applicable

Completed

• Conditions: Malocclusion
• Interventions: Device: Orthodontic archwire

• Registration Number: NCT02659813
• Lead Sponsor: University of Dundee

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.

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 Timeline

• Study First Submitted: 2016-01-14
• Study First Submitted QC: 2016-01-19
• Study First Posted: 2016-01-20
• Study Start: 2016-10
• Primary Completion: 2019-04
• Study Completion: 2021-08-17
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-15
• Last Update Posted: 2021-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Firewire	Orthodontic archwire	Experimental Group 1. Novel orthodontic archwire.
CNiTi	Orthodontic archwire	Experimental Group 2. Current best available orthodontic archwire

Primary Outcome Measures

Name	Time	Method
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

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