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
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
Dr Ganavi G Nayak
Rajarajeswari dental college and hospital bengaluru
