ArchWire-RaCE: Orthodontic Archwires: a Randomised Clinical Trial of Effectiveness
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Dundee
- Enrollment
- 64
- Primary Endpoint
- Rate of tooth movement
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- 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
Arms & Interventions
Firewire
Experimental Group 1. Novel orthodontic archwire.
Intervention: Orthodontic archwire (Device)
CNiTi
Experimental Group 2. Current best available orthodontic archwire
Intervention: Orthodontic archwire (Device)
Outcomes
Primary Outcomes
Rate of tooth movement
Time Frame: Initial six months of treatment
Rate teeth move in response to force from archwire measured in millimetres on digital dental models
Secondary Outcomes
- 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)