Malocclusion
Conditions
Keywords
Orthodontic wires
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).
Interventions
DEVICEOrthodontic archwire
Archwire used to align teeth in an orthodontic fixed brace
Sponsors
Ormco Corporation
University of Dundee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed