ArchWire-RaCE: Orthodontic Archwires: a Randomised Clinical Trial of Effectiveness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 主要终点
- Rate of tooth movement
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Rate of tooth movement
时间窗: Initial six months of treatment
Rate teeth move in response to force from archwire measured in millimetres on digital dental models
次要结局
- 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)