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临床试验/NCT06576960
NCT06576960已完成不适用

Caries Inhibitory Effect of Nano Silver Varnish Versus Tri Calcium Phosphate Varnish Among Children With Visual Impairment

Hadeer Mohammed Abd El wahab1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年10月11日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Salivary PH

研究概览

简要总结

Assessment of pH,streptococcus mutants count, lactobacillus count and immunoglobulin A among visually impaired children after nano silver varnish application it tri calcium phosphate phosphate varnish application

详细描述

Sixty children will be randomly divided into three equal treatment groups, composed of 20 children each, according to the type of material used as follows:

  • Group I: children will receive oral health education and nano silver fluoride varnish.
  • Group II: children will receive oral health education and tri calcium phosphate varnish.
  • Group III: children will receive oral health education

for all children ,Assessment of pH, streptococcus mutants count, lactobacillus count and immunoglobulin A will be assessed at baseline, one day , 3 months and 6 months after application

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)

入排标准

年龄范围
8 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Visually impaired children

排除标准

  • uncooperative children or children not willing to participate in the study.
  • Children with systemic diseases
  • Children with bronchial asthma.
  • Children who were on antibiotic or medications that might affect oral flora or salivary flow taken within the previous 3 months
  • History of fluoride treatment in the past 3-4 weeks.

研究组 & 干预措施

nano silver varnish

Experimental

new fluoride varnish

干预措施: Nano silver fluoride varnish and tri calcium phosphate varnish (Drug)

tri calcium phosphate varnish

Experimental

fluoride varnish contain calcium phosphate

干预措施: Nano silver fluoride varnish and tri calcium phosphate varnish (Drug)

结局指标

主要结局

Salivary PH

时间窗: 6 months

Salivary power of hydrogen at baseline, one month, 3months and six months after intervention

Lactobacillus count

时间窗: 6 months

Count of bacteria at baseline, one day, 3months and six months after intervention

Immunoglobulin A

时间窗: 6months

Level of immunoglobulin A at saliva at baseline, one day, 3months and 6 months after intervention

Salivary streptococcus mutants count

时间窗: 6months

Count of bacteria at baseline, one day, 3months and six months after intervention

次要结局

未报告次要终点

研究者

发起方
Hadeer Mohammed Abd El wahab
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hadeer Mohammed Abd El wahab

El Mahalla Elkobra

Tanta University

研究点 (1)

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