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临床试验/CTRI/2025/10/096600
CTRI/2025/10/096600已完成不适用

Comparative evaluation of surface morphology and Streptococcus mutans adhesion on retrieved Zinc Oxide nanoparticle coated stainless steel archwire vs uncoated wires- A randomized clinical trial

Dr Gunika Tayal1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2025年11月24日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
18
试验地点
1
主要终点
To evaluate streptococcus mutans adhesion

研究概览

简要总结

The present study is a randomized split mouth clinical trial conducted on patients undergoing fixed orthodontic treatment. The purpose of the study is to compare the surface morphology and Streptococcus mutans adhesion on zinc oxide nanoparticle coated stainless steel archwires with uncoated stainless steel archwires after 4 to 6 weeks of intraoral use. The intervention group will receive 0.016 x 0.022 inch stainless steel archwires coated with zinc oxide nanoparticles while the control group will receive uncoated 0.016 x 0.022 inch stainless steel archwires. A total of 18 patients aged 12 to 30 years requiring orthodontic treatment with 0.022 MBT prescription brackets and with good oral and periodontal health will be included in the study. Patients with systemic disorders, poor oral hygiene, known metal allergies, history of antibiotic or anti inflammatory drug use in the past three months, or habits such as tobacco chewing, alcohol consumption will be excluded. The primary outcome of the study is the evaluation of Streptococcus mutans adhesion by colony count method. The secondary outcome is the assessment of surface morphology of retrieved wires using atomic force microscopy. Statistical analysis will be performed using SPSS version 21 with appropriate parametric or non parametric tests. A confidence interval of 95 percent, a significance level of 5 percent and a study power of 90 percent will be applied.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
12.00 Year(s) 至 30.00 Year(s)(—)
性别
All

入选标准

  • Age 12 to 30 years Patients requiring fixed orthodontic treatment with 0.022 MBT prescription Good general, gingival, and periodontal health.

排除标准

  • Systemic disorders Use of antibiotics or anti-inflammatory drugs in last 3 months Poor oral hygiene Known metal allergy Habit of pan masala or tobacco chewing, alcohol or aerated drink consumption.

结局指标

主要结局

To evaluate streptococcus mutans adhesion

时间窗: after 4-6 weeks

次要结局

  • surface morphology (AFM analysis)(after 4-6 weeks)

研究者

发起方
Dr Gunika Tayal
申办方类型
Other [(self)]
责任方
Principal Investigator
主要研究者

Dr Gunika Tayal

Bharati Vidyapeeth Dental College and Hospital Pune

研究点 (1)

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