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临床试验/CTRI/2024/09/074330
CTRI/2024/09/074330
尚未招募
2/3 期

Comparative evaluation of effectiveness of Probiotic chewing tablets and Probiotic curd in prevention of dental caries in 3-6 years old children: A Randomised controlled clinical trial

Laxmi Narayan Darmode1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年9月30日最近更新:

概览

阶段
2/3 期
状态
尚未招募
发起方
Laxmi Narayan Darmode
入组人数
90
试验地点
1
主要终点
1.Probiotic curd was more effective in reducing Streptococcus mutans (a bacteria associated with tooth decay) counts in saliva and plaque.

概览

简要总结

The preventive role of probiotics using chewing tablets and curd is well describe in the literature. Curd contains probiotic bacterial strains L. acidophilus (La5) and B. lactis (Bb12). It is preferred because fresh curd contains starter cultures (Lactobacillus delbrueckii subspecies bulgaricus and streptococcus thermophilus). Curd is widely accepted and eaten regularly. Curd is a semisolid food with a continuous gellike consistency that gradually disappears from the mouth. A dairybased carrier was chosen to hold the probiotic bacteria in order to avoid bacterial acidogenicity.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Investigator Blinded

入排标准

年龄范围
3.00 Year(s) 至 6.00 Year(s)(—)
性别
All

入选标准

  • 1.Children with the age group of 3-6 years.
  • 2.Children irrespective of gender will be selected.
  • 3.Absence of severe systemic disease or allergy 4.Co-operative children.

排除标准

  • 1.Ongoing medication with antibiotics 2.Regular use of other probiotic products (dairy products or other supplements) 3.Caries lesions with a need for extractions 4.Mentally or physically disabled children.

结局指标

主要结局

1.Probiotic curd was more effective in reducing Streptococcus mutans (a bacteria associated with tooth decay) counts in saliva and plaque.

时间窗: At baseline, 1 month, 3 month and 6 months

2.Both groups showed significant reduction in dental caries incidence and plaque accumulation.

时间窗: At baseline, 1 month, 3 month and 6 months

次要结局

  • Both probiotic chewable tablets and probiotic curd were effective in preventing dental caries.(At baseline, 1 month, 3 month and 6 months)

研究者

发起方
Laxmi Narayan Darmode
申办方类型
Other [Self ( Laxmi Narayan Darmode)]
责任方
Principal Investigator
主要研究者

Dr Rehan Khan

Maharashtra University of Health Sciences, Nashik

研究点 (1)

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