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临床试验/NCT05860738
NCT05860738招募中不适用

The Effect of Autoclave Cycles on the Mechanical Properties and Surface Roughness of NITI Archwires: Invivo Study.

Cairo University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年5月4日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
modulus of elasticity

研究概览

简要总结

The aim of this study is to evaluate the effect of different autoclave cycles (universal and rapid cycles) on the surface roughness and mechanical properties of NiTi archwires.

详细描述

Three groups of 0.016 x 0.022 inch NiTi archwires (American Orthodontics, Wisconsin, USA) will be investigated in this study. The first group of wires will be investigated in the as-received form. The two other groups will be installed in the patients mouth for 4 weeks, and then retrieved, cleaned using ultrasonic cleaner, dried and packaged. The second group will be autoclaved through the rapid cycle (4 mins, 134oC) and the third group will be autoclaved through the universal cycle (20 mins, 121 oC). The autoclave used in this study is (Anthos A-17 Autoclave, Italy).

Each wire will be cut into 3 segments; 2 straight distal segment and one anterior curved segment. The distal segments will be used for tensile testing to derive the mechanical properties and the anterior segment will be used to measure the surface roughness.

The mechanical properties (load deflection curve) will be measured with a universal testing machine (Model 4466, Instron Corp, Canton, Mass) with a 1000-kg load cell at 37°C. Each wire segment will be placed in the jaws of the machine. A grip is positioned at each end of the wire with a distance of 40 mm between the jaws. The machine will be operated in the tensile mode with a crosshead speed of 5 mm per minute. Three characteristics of each sample will be quantified from the readouts: ultimate tensile strength (kg/mm2), elongation rate (%), and modulus of elasticity (kg/mm2).

Atomic force microscopy (AFM) is a non-invasive method for three dimensional analysis of surface roughness. Anterior archwire segments will be evaluated using the AFM (Anton Paar GmbH-Tosca200 AFM, Germany) employing the tapping mode 500 micrometer increment with a rate of 1 line per second. Average surface roughness (Sa) in nanometers will be obtained by software analysis (Mountains 8.2 Software-Digital Surf, Besancon, France). The average surface roughness of each specimen will be measured at three different sites and the mean (Sa) will then be calculated.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • patients with moderate crowding requiring leveling and alignment

排除标准

  • severe crowding.
  • extraction cases

结局指标

主要结局

modulus of elasticity

时间窗: one month

springiness of the archwires

次要结局

  • surface roughness(one month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amira Aboalnaga

principal investigator

Cairo University

研究点 (1)

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