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临床试验/NCT04196829
NCT04196829Unknown4 期

Comparative Evaluation of Staining Potential and Caries Arresting Effect of Silver Diamine Fluoride⁄Potassium Iodide and Silver Diamine Fluoride in Carious Primary Anterior Teeth

Cairo University1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2020年1月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
15
试验地点
1
主要终点
staining potential

研究概览

简要总结

the main objective of this study is to evaluate staining potential and Caries Arresting Effect of silver diamine fluoride⁄potassium Iodide and silver diamine fluoride in carious anterior primary teeth

详细描述

Despite increased attention on caries prevention, not all children receive preventive treatments and large numbers still experience tooth decay. Primary care providers have had little option other than invasive and costly specialist treatment in the hospital under general anesthesia. In this context, there is interest in simple treatments to halt progress of carious lesions after tooth decay onset. Among these simple treatments is silver diamine fluoride (SDF) treatment. The major drawback to SDF treatment has been its black staining, which has limited its use. To counter the staining, researchers have tested SDF treatment immediately followed with application of saturated solution of potassium iodide (KI).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
3 Years 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children with carious primary anterior teeth.
  • Children with no spontaneous pain

排除标准

  • Tooth mobility
  • Signs of pulpal or periapical infection
  • Severe medical conditions that would not allow management in the clinic
  • Sensitivity to silver or other heavy-metal ions
  • Presence of any gingival or perioral ulceration or stomatitis

研究组 & 干预措施

silver diamine fluoride ⁄ potassium Iodide

Experimental

38% silver diamine fluoride and a saturated solution of potassium iodide

干预措施: silver diamine fluoride ⁄ potassium Iodide (Drug)

silver diamine fluoride

Active Comparator

38% silver diamine fluoride

干预措施: Silver Diamine Fluoride (Drug)

结局指标

主要结局

staining potential

时间窗: base line and Immediately after material application

change in color of carious lesion using spectrophotometer with unit of measurement percent

次要结局

  • caries arresting effect(3 months, 6 moths, 9 months, 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mariam Mohsen Aly

lecturer in pediatric dentistry and dental public health, faculty of dentistry, Cairo university

Cairo University

研究点 (1)

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