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临床试验/NCT06089720
NCT06089720已完成不适用

An Antimicrobial Effect of ZnO Nanoparticles Coated Orthodontic Molar Tube (A Randomized Clinical Trial)

University of Baghdad2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2023年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
2
主要终点
Evaluation of the antimicrobial Effect of ZnO Nanoparticles Coated orthodontic molar tube in relative to the uncoated orthodontic molar tube

研究概览

简要总结

Orthodontic treatment is an elective procedure to improve the patient's dentofacial appearance. The complex design of fixed appliances provides a platform that leads to increased plaque accumulation around orthodontic brackets. So, the risk to develop demineralization area adjacent to orthodontic brackets is a major barrier in achieving this goal. Oral hygiene is greatly complicated following the placement of fixed orthodontic Appliances. Molar tube in place are considered for nearly all patients experiencing fixed orthodontic therapy over the whole treatment period, which normally lasts 1.5 to 2 years. To the best of the authors' knowledge, the application and antimicrobial efficacy of zinc oxide (ZnO) nanoparticles coating on orthodontic molar tube material has not been integrated clinically. White spot lesions during orthodontic treatment have a documented etiology. Briefly, the accumulation of plaque and food around brackets, bands, wires, and other attachments caused decreased pH and increased S. mutans colonization, which led to the possibility of clinical demineralization.

The aims of study are to assess the antimicrobial effect of nanoparticle coated stainless steel orthodontic molar tube material (OMT) with zinc oxide (ZnO) nanoparticles in relative to uncoated orthodontic molar tube (UOMT) against the streptococcus. mutans& lactobacllius bacteria that cause white spot lesion around the fixed orthodontic appliance. .

详细描述

Aim:

The aim of this prospective randomized clinical trial is to assess the antimicrobial efficacy of nanoparticle coating stainless steel orthodontic molar tube (OMT) with zinc oxide (ZnO) nanoparticles in relative to uncoated orthodontic molar tube (UOMT).

Objectives:

  1. Compare the antimicrobial properties of the zno nanoparticle coated OMT in relative to uncoated orthodontic molar tube (UOMT).
  2. Evaluate and compare the clinical bond failure rate between the coated OMT and the UOMT. The null hypothesis is that there is no significant difference in the antimicrobial effects and the rate of bond failure between the non-coated and coated stainless steel orthodontic molar tube using ZnO NPs.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

盲法说明

When applications of orthodontic molar tubes to patients mouth through routine orthodontic treatment, the clinicians will explain the procedure to patients without knowing the about which side coated or not .

入排标准

年龄范围
14 Years 至 30 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who are seeking or under orthodontic treatment with fixed appliances Subjects must be healthy &well fit medically.
  • Subjects with no signs or symptoms of oral mucosal disease.
  • Subjects should not receive oral antimicrobials or antibiotic therapy for more than 3 months prior to sample enrolling.
  • non-pregnant or lactating Female patient.
  • Subjects is not smokers

排除标准

  • Patients with a greater tendency to accumulate plaque (e.g., having congenital anomalies such as cleft lip and palate) or undergo orthognathic surgery

结局指标

主要结局

Evaluation of the antimicrobial Effect of ZnO Nanoparticles Coated orthodontic molar tube in relative to the uncoated orthodontic molar tube

时间窗: After 2 weeks

Compare the antimicrobial properties of the zno nanoparticle coated OMT in relative to uncoated orthodontic molar tube (UOMT), through taking swaps from patient and sent to laboratory to culturing swaps samples to evaluating the colony forming unit number of S. mutans\&lactobacillus bacteria which consider mean cause of white spot lesion and compare with the uncoated orthodontic molar tube swaps cultures.

次要结局

  • Evaluate and compare the clinical bond failure rate between the coated orthodontic molar tube and the uncoated orthodontic molar tube(3 months)

研究者

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

Ahmed Kamil Jawad

Doctor

University of Baghdad

研究点 (2)

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