Comparison of Mechanical Properties and Clinical Efficacy Between Heat-activated and Superelastic Nickel-Titanium (NiTi) Archwires.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Quantity of anterior mandibular crowding resolution
研究概览
简要总结
Objective: to compare the changes of the mechanical properties measured by tensile test and three point bending test of two NiTi archwires (heat-activated and superelastic); when exposed to the oral conditions during the first three months of orthodontic treatment and to evaluated their clinical efficacy in lower arch crowding resolution in the anterior mandibular arch.
Methods: Randomized clinical trial in 54 orthodontic patients with moderate crowding. They are going to be randomly assigned in to two intervention groups, each group with 27 patients. One group are going to be treated with heat-activated NiTi archwires and the other group with superelastic NiTi archwires. The patients are going to be followed up for three months and cast models will be taken every month. Measures of anterior lower arch crowding resolution are going to be taken by previously-calibrated operators. Six archwires of each group will be chosen at random and will have tensile test and three-point bending test and the mechanical properties are going to measure before and after its clinical use. The outcomes are going to be determined and compared between groups, with correspondent statistical test and the results are going to be analyzed.
详细描述
PICO QUESTION:
- Does the amount of the resolution of the anterior lower arch crowding increase in the patients with superelastic NiTi archwire compared with the patients with heat-activated NiTi archwire during the first three months of orthodontic treatment and/or its mechanical properties change after three months of clinical use?
Population: Orthodontic patients with moderate anterior mandibular crowding Intervention: .014" Superelastic NiTI archwire (3M Unitek, Monrovia, CA) Comparison: .014" Heat activated NiTi archwire (3M Unitek, Monrovia, CA)
Outcomes:
Primary Outcomes:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Only one of the investigators are going to know the archwire assigment, the other ones who are going to do the measures are going to be blinded.
入排标准
- 年龄范围
- 13 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Orthodontic treatment without extraction with moderate anterior mandibular crowding (little index: 4-6mm)
- •Age range between 15-25 years' old
- •Non gingivitis or untreated caries at the start of orthodontic treatment
- •Not need for intermaxillary elastics, striping, open compressed Nit springs, active labial arch, stainless ligature, during the first to the third months of orthodontic treatment
- •Complete orthodontic appliances in the lower arch (at minimum from first molar to the first molar)
排除标准
- •Patients with systemic disease
- •Medicated patients (long term use of antibiotics, Phenytoin, cyclosporine, anti- inflammatory drugs, systemic corticosteroids, and calcium channel blockers)
- •Diseases that may affect dental movement
- •Syndromic patients
- •Patients with a history of trauma and/or root resorption at the lower arch
- •Patients who do not attend more than one month to the appointment
- •Lower .014" NiTi archwires that fracture during the first three months of the study.
- •Patients with previous orthodontic treatment
结局指标
主要结局
Quantity of anterior mandibular crowding resolution
时间窗: baseline and three months
MBT prescription .022 slot. Alginate impressions and cast models at the beginning of the study, immediately after the first, second and third month of the orthodontic treatment. Measures of anterior lower arch crowding resolution are going to be taken by previously-calibrated operators.
次要结局
- Archwire deformation(baseline and three months)
- Changes in Mechanical properties(baseline and three months)
研究者
Suly Amaya
Teacher Orthodontic department
Fundación Universitaria CIEO