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临床试验/NCT07355465
NCT07355465尚未招募不适用

The Effect of Salvadora Persica (Miswak) Compared to Fluoridated Toothpaste on Children's Teeth Diagnosed With Molar-Incisor Hypomineralization (MIH): A Randomized Clinical Trial

King Abdulaziz University0 个研究点目标入组 30 人开始时间: 2026年1月29日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
30

研究概览

简要总结

Molar-Incisor Hypo mineralization (MIH) was first described in 2001 as a developmental enamel defect . It is a condition in which the enamel of at least one first primary molar is affected with a qualitative defect causing abnormal translucency appearing as demarcated opacities; The permanent incisors and second primary molars can also be affected . MIH has adverse consequences on the oral health and child's quality of life. It increases the risk of caries, discomfort and teeth sensitivity .

MIH management comprises a variety of treatment options ranging from total caries removal to the polar opposite treatment option of no caries removal and non-invasive methods used to prevent caries progression . Dental caries prediction and prevention are now more important than dental caries diagnosis and treatment. Recently, the reasons for repairing dental cavities have been narrowed, and caries prevention is being used to reduce caries . Salvadora persica, commonly known as Miswak was used as a toothbrush for many years among many countries . It was reported to have a significant effect on oral health and caries prevention .Other studies have found a consistent link between the use of Miswak and a reduction in oral bacteria. However, a comprehensive assessment of using Miswak in the treatment and control of MIH among young children has yet to be conducted.

Therefore, the aim of this clinical trial is to assess the effect of SalvadoraPersica and fluoridated toothpaste on controlling hypersensitivity and preventing caries among children with MIH in primary schools. Additionally, this trial will evaluate the shade of the hypo-mineralized enamel before and after using SalvadoraPersica and fluoridated toothpaste

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Healthy children with age ranged between 6-12 years old
  • Presence of at least one first permanent molar and incisor diagnosed with MIH.
  • The MIH-affected teeth will have a clinical presentation of white, creamy, yellow, or brown demarcated opacities

排除标准

  • Medically compromised children.
  • Unwillingness to participate or be randomly assigned to the study groups.
  • Receiving treatment for controlling MIH other than fluoride application

研究者

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

Heba sabbagh

professor

King Abdulaziz University

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