Clinical trial NCT02659813: Orthodontic Archwire Effectiveness Trial
Official title: ArchWire-RaCE: Orthodontic Archwires: a Randomised Clinical Trial of Effectiveness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion
Keywords: Orthodontic wires
Lead sponsor: University of Dundee
Sponsor class: OTHER
Collaborators: name: Ormco Corporation
First posted: 2016-01-20
Enrollment: 64
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Rate of tooth movement
timeFrame: Initial six months of treatment
Secondary outcomes:
measure: Pain assessed by Visual Analogue Scale
timeFrame: Initial six months of treatment
measure: Tooth Root Resorption assessed on panoramic radiograph using method of Pandis et al (2008)
timeFrame: 18 months
measure: Patient experience assessed by Questionnaire
timeFrame: Initial six months of treatment
Other outcomes:
Locations:
Study officials:
affiliation: University of Dundee
name: David R Bearn, BDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.