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临床试验/CTRI/2024/08/071874
CTRI/2024/08/071874尚未招募不适用

Evaluation and correlation of salivary matrix metalloproteinase 8 levels before and after application of MI varnish 38 percent silver diamine fluoride and nano silver fluoride in children with early childhood caries an in vivo study

Dr Ganavi G Nayak1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2024年8月12日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
45
试验地点
1
主要终点
Evaluate salivary MMP-8 levels before and after application of MI varnish, 38% SDF and NSF in children with ECC using ELISA.

研究概览

简要总结

A total of 45 children  who  meets  inclusion  criteria will be selected and divided into three  experimental groups, Group 1 ( n =15), Group 2 ( n = 15), Group  3 ( n= 15) . All   subjects will be instructed to refrain from eating  and drinking for 1 hour  before the saliva  sample collection. Pre-intervention unstimulated saliva sample will be collected by spitting method. The patients will be asked to rinse the mouth with filter water  twice before the collection . After the oral rinse, children  will be asked  to  spit  the saliva  into sterile tubes for a period of 5 minutes . Then these tubes will be sealed immediately after sample collection and refigerated at - 20 degree celsius and stored in  laboratory until further analysis. Group 1 - MI varnish, Group 2- 38% SDF , Group 3 -NSF will be applied on selected carious teeth  with micro brush and left for 2 minutes . Post  application  instructions will be given. Patients will be recalled after 1 month and 3 month and post- interventional unstimulated salivary samples will be collected by the same procedure as mentioned above. All samples will be subjected to ELISA to evaluate and compare salivary MMP- 8 levels. Results obtained will be subjected to statistical data.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
3.00 Year(s) 至 6.00 Year(s)(—)
性别
All

入选标准

  • 1.Children with 3 to 6 years of age of both the genders 2.Children with DC greater than or equal to 3 in primary teeth , ICDAS II criteria, CODE 02 and 03 3.Parents giving consent for the study.

排除标准

  • 1.Children who received fluoride topical application during the last 1 month.
  • 2.Children requiring special health care needs.
  • 3.Pulpally involved and grossly decayed teeth.
  • 4.Children who were on antibiotic therapy within the past 3 months.
  • Children with genetic diseases or syndrome.

结局指标

主要结局

Evaluate salivary MMP-8 levels before and after application of MI varnish, 38% SDF and NSF in children with ECC using ELISA.

时间窗: Base line | 1 month | 3 months

次要结局

  • Correlation & comparision of intragroup & intergroup salivary MMP- 8 levels before & after application of MI varnish, 38% SDF & NSF in children with ECC using ELISA(Base line)

研究者

发起方
Dr Ganavi G Nayak
申办方类型
Other [Self funded ]
责任方
Principal Investigator
主要研究者

Dr Ganavi G Nayak

Rajarajeswari dental college and hospital bengaluru

研究点 (1)

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