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临床试验/NCT05979636
NCT05979636已完成不适用

Effect of Toothpaste Containing Novamin on Streptococcous Mutans Count in Dental Plaque of High Caries Risk Children (Randomized Controlled Clinical Trial)

Hams Hamed Abdelrahman1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2022年12月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
Change in bacterial count in dental plaque

研究概览

简要总结

Inhibition of streptococcus mutans can be effective to prevent caries in high caries-risk children. The aim of the study is to evaluate the effect of Novamin on streptococcus mutans in the plaque of high caries-risk children.

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
Single (Outcomes Assessor)

入排标准

年龄范围
3 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Medically healthy children.
  • No erupting first permanent molars.
  • High caries risk children; Have visible cavities or have a visible plaque on their teeth.
  • Cooperative (Positive or definitely positive), according to Frankl's Behavior Rating Scale

排除标准

  • History of intake of antibiotics for the past 3-4 weeks.
  • History of professional fluoride treatment over 2 weeks before the study.
  • Children with tooth structure defects.
  • Children unable to return for recall visits

结局指标

主要结局

Change in bacterial count in dental plaque

时间窗: 1 week, 2 weeks and 4 weeks

The samples will be collected from all children in the study and the level of S.mutans will be recorded.

次要结局

未报告次要终点

研究者

发起方
Hams Hamed Abdelrahman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hams Hamed Abdelrahman

Assistant lecturer of DPH and Clinical statistician

Alexandria University

研究点 (1)

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