跳至主要内容
临床试验/CTRI/2023/10/059148
CTRI/2023/10/059148尚未招募Phase 3 4

Evaluation of Antimicrobial Effect of Silver Nanoparticle Coated Orthodontic Bands on Streptococcus mutans:A Split Mouth Randomized Controlled Study

MGM Dental College and Hospital, Navi Mumbai1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2023年1月11日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
14
试验地点
1
主要终点
Primary outcome is to evaluate the antimicrobial effectiveness of silver nanoparticle coated orthodontic bands on streptococcus mutans.The count of streptococcus mutans around the bands coated with silver nanoparticle after removing them a month after the placement will be recorded and will be compared to the count of streptococcus mutans around the uncoated bands.

研究概览

简要总结

The study is A Split Mouth Randomized Controlled Study. Silver nanoparticles have been used in dentistry in various fields such as endodontics, periodontics because of its antimicrobial activity. Recently silver nanoparticles have been introduced in orthodontics for coating of bands. In vitro studies have shown the antimicrobial activity of silver nanoparticles. This study intends to evaluate the clinical efficiency of silver nanoparticle coated orthodontic bands on commonly found oral pathogen streptococcus mutans. For this study, patients coming to the department of orthodontics will be selected as per Convenient, Consecutive, Consenting sampling for their participation in the study. A sample size of 14 patients will be taken (n=14). Two groups will be taken in each patient: Group A (Uncoated Bands) and Group B (AgNP Coated Bands). FESEM and EDS tests will be done prior to placing the bands in patients to check the surface characteristics of bands. Allocation of bands in patient’s mouth either on left or right side will be based on block randomization technique. Bands will be removed from patient’s mouth after 1 month of placement. Bands will be checked for streptococcus mutans count by counting CFU/ml and FESEM and EDS tests to check retention of nanoparticles. Results will be obtained in the form of images and graphs for FESEM and EDS test and in the form of CFU/ml for bacterial count test.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

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

入选标准

  • Patients coming to the department of orthodontics, undertaking orthodontic treatment 2)Patient giving consent for the study 3)Medical coating of silver nanoparticles on bands (carried out by PVD technique).

排除标准

  • Any other medical coating than silver nanoparticles 2)Patients with systemic disease 3)Patient taking any antibiotic medications 4)Patients with periodontal disease 5)Patients with active caries on the site of placement of band •Patients with age below 18 and above 35 years.

结局指标

主要结局

Primary outcome is to evaluate the antimicrobial effectiveness of silver nanoparticle coated orthodontic bands on streptococcus mutans.The count of streptococcus mutans around the bands coated with silver nanoparticle after removing them a month after the placement will be recorded and will be compared to the count of streptococcus mutans around the uncoated bands.

时间窗: After the bands are placed in the mouth, 1 month after the placement, the bands both coated and uncoated will be removed and they will be assesed for antimicrobial activity against streptococcus mutans

次要结局

  • secondary outcome is to check the retention of silver nanoparticles on bands(it will be checked after 1 month of band placement)

研究者

发起方
MGM Dental College and Hospital, Navi Mumbai
申办方类型
Private hospital/clinic

研究点 (1)

Loading locations...

相似试验