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临床试验/CTRI/2026/02/105075
CTRI/2026/02/105075尚未招募不适用

Probiodent: Dual-Action Toothpaste for Early Caries Prevention

Dr Sakshi Sharan1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年3月16日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1

研究概览

简要总结

Dental caries is among the most prevalent chronic diseases in children globally, affecting 60–90% of school-aged children according to the World Health Organization. It is primarily caused by the acidogenic activity of Streptococcus mutans, which thrives in dental biofilms formed in poor oral hygiene conditions. While fluoride-based toothpastes have long been the cornerstone of caries prevention, their excessive ingestion in children under 6 years can lead to dental fluorosis and systemic complications. This concern becomes more pressing in fluoride-rich regions like Chhattisgarh, where natural groundwater contains fluoride levels that often exceed the WHO safety limit of 1.5 mg/L, contributing to a high prevalence of Molar Incisor Hypomineralization (MIH) and enamel developmental defects.

 To address this challenge, the present study proposes the development of a fluoride-free pediatric toothpaste, named Probiodent, incorporating two synergistic agents: a probiotic strain known for its anti-S. mutans activity and nano-hydroxyapatite, a synthetic biomimetic agent proven to aid in enamel remineralization comparable to or even better than fluoride in children.

The toothpaste will be formulated in a government-authorized laboratory at Smt Kishoritai Bhoyar College of Pharmacy, tested for physical parameters including pH, viscosity, spreadability, and foamability, and benchmarked against commercial pediatric dentifrices to determine its safety and suitability for daily use.

In the second phase, in-vitro microbial testing will be conducted at the Department of Microbiology, Rungta College of Dental Sciences and Research. This will be followed by SEM analysis to check the remineralisation potential at IIT Bhilai. This study aims to provide a regionally relevant, biologically safe, and clinically effective alternative to fluoride toothpastes in pediatric dental care.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
10.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Only Retained Deciduous Tooth that need to be Extracted to aid in Eruption of Permanent Teeth will be used.
  • Healthy Tooth with No Clinical Dental Caries.

排除标准

  • Tooth with dental caries.
  • Healthy teeth that do not need extraction.

研究者

发起方
Dr Sakshi Sharan
申办方类型
Other [Principal Investigator (self)]
责任方
Principal Investigator
主要研究者

Dr Sakshi Sharan

Rungta College Of Dental Sciences And Research

研究点 (1)

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