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临床试验/CTRI/2020/04/024709
CTRI/2020/04/024709招募中1 期

A COMPARATIVE EVALUATION OF FRICTIONAL CHARACTERISTICS OF TWO ARCHWIRE MATERIALS

SNEHA R ISMAIL1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年6月7日最近更新:

试验速览

阶段
1 期
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
There will be difference in mechanical parameters between two archwire wires in as received state

研究概览

简要总结

During orthodontic treatment, friction in the bracket - archwire interface plays an important role in the rate of orthodontic tooth movement as; a decrease in friction might shorten the treatment duration and improve anchorage control. The factors responsible for friction between bracket - arch wire interface include; archwire materials, environment (wet or dry), and surface roughness. The proper understanding of arch wire behaviour in clinical scenario will help in appropriate selection of arch wire in orthodontic mechanotherapy.

AIMS

The aim of this research is to compare and characterize two orthodontic archwire alloys, Copper Nickel-Titanium (CuNiTi) and Titanium-Niobium-Tantalum-Zirconium (Ti-Nb-Ta-Zr) based on the mechanical parameters namely, frictional resistance, surface characteristics and elemental analysis. These mentioned parameters are evaluated, both before employing the arch-wire for initial alignment and after the initial alignment.

MATERIALS AND METHODS

40 specimens each of CuNiTi and Gummetal (Ti-Nb-Ta-Zr) wires are to be used in this study.Testing specimens include archwires of 0.016 inch round CuNiTi archwires and 0.016inch Ti-Nb-Ta-Zr archwires.The study is planned to be carried out through two stages.40 subjects with Irregularity Index of Mild level (Scores 1-3) and Moderate level (Scores 4-6) are selected. Subjects will be randomly selected into two groups for initial alignment with CuNiTi archwire and Ti-Nb-Ta-Zr archwire. Each group comprises of 20 subjects.

The1ststage of the study is conducted on the archwire specimens in the “as received†state. The wires are mechanically evaluated for frictional resistance by an Instron Universal Testing Machine. The surface characteristics are evaluated by scanning electron microscope and elemental analysis by X-Ray Fluorescence (XRF). The obtained parameter values will be documented.

The remaining 20 archwire specimens each of NiTi and Gummetal wires are then employed for initial alignment in the subjects selected for study. After the initial alignment phase, the archwires are removed and disinfected with 2% glutaraldehyde solution. The archwires are then mechanically evaluated and the parameter values will be duly documented. The obtained values are then comparatively evaluated and statistically analysed.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
14.00 Year(s) 至 20.00 Year(s)(—)
性别
All

入选标准

  • Littles irregularity index 2-4 mm Patients with no history of orthodontic treatment Confirmation that all permanent teeth were fully erupted from 2nd molar to 2nd molar No history of trauma to periodontium.

排除标准

  • Known allergy to nickel or to any other metal History of long term drug uses History of any systemic diseases Abnormal chewing habits Patients with proximal caries or restorations.

结局指标

主要结局

There will be difference in mechanical parameters between two archwire wires in as received state

时间窗: 6 months (24 weeks)

次要结局

  • There will be difference in mechanical parameters between two archwire soldiers after initial alignment(8 months)

研究者

发起方
SNEHA R ISMAIL
申办方类型
Other [self]

研究点 (1)

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