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临床试验/CTRI/2024/12/078661
CTRI/2024/12/078661尚未招募1 期

Green synthesised silver nanoparticle coated elastomeric ligatures on patients undergoing orthodontic treatment

D.Divakar1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年1月15日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
Enamel demineralisation

研究概览

简要总结

Green synthesised silver nanoparticle coated elastomeric ligatures on patients undergoing orthodontic treatment-A split mouth study

Aim-The aim of the study is to prepare, develop and test green synthesised nano silver coated elastomeric ligatures

Objective and rationale-Commercially available elastomeric ligature have disadvantages with regards to excessive plaque accumulation resulting in demineralisation of enamel manifesting as white spot lesions. Also,there is a constant degradation of its elasticity with time, exposure to oral fluids.Therefore the incorporation of silver nano coating in elastomeric modules to study the antibacterial effect, extent of demineralisation and other physical properties.

Sample size-20 patients

A split mouth study

Methodology-

The methodology involves synthesizing and characterizing silver nanoparticles using plant extracts from clove and cardamom. These nanoparticles will then be coated to elastomeric ligatures through an electron beam sputtering process. The sample size, determined using G*Power version 3.0.1 with a power of 0.8, consists of 20 patients undergoing fixed orthodontic treatment with the MBT system. The study adopts a split-mouth design in patients undergoing fixed orthodontic treatment with the MBT system, focusing on cases requiring the extraction of all premolars or upper premolars. On one side, commercially available elastomeric ligatures will be used, while on the contralateral side, elastomeric ligatures coated with green synthesis silver nanoparticles (synthesized using clove and cardamom extracts via electron beam sputtering) will be applied. After 3 months, the designated premolars from both sides will be extracted and analyzed using scanning electron microscopy (SEM) to evaluate enamel demineralization. Additional assessments will include the antibacterial properties, tensile strength, modulus of elasticity, and color stability of the elastomeric ligatures. Informed consent will be obtained from all participants for the use of their case records and extracted teeth in research and publication.These patients will have their ligatures coated with silver nanoparticles. Informed consent will be obtained from all participants for the use of their case records in scientific research and publication.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Outcome Assessor Blinded

入排标准

年龄范围
15.00 Year(s) 至 35.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing Orthodontic treatment with fixed appliance.
  • MBT brackets.

排除标准

  • Self lighting brackets Clear aligner technique.

结局指标

主要结局

Enamel demineralisation

时间窗: 3 months

次要结局

  • Anti microbial property(Physical properties-Tensile strength,modulus of elasticity ,Colour stability)

研究者

发起方
D.Divakar
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Anjusha Divakar

Saveetha Dental College and Hospitals

研究点 (1)

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