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临床试验/NCT06174194
NCT06174194已完成不适用

Effect of Sugar-Free Chewing Gum Containing Tulsi Extract on Salivary Streptococcus Mutans in a Group of Children

Faculty of Dental Medicine for Girls2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2022年1月1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
33
试验地点
2
主要终点
Salivary Streptococcus mutans Count

研究概览

简要总结

The goal of this clinical trial was to explore how adding Tulsi extract, a natural plant substance, to chewing gum affects the levels of Streptococcus mutans, type of bacteria that cause dental caries, in the saliva of children aged 4 to 11 years. Participants should not use removable prosthetics or orthodontic appliances and had had not used antibiotics in the 2 weeks preceding sample collection.

We want to answer this main question:

Can chewing gum with Tulsi extract significantly reduce the number of Streptococcus mutans bacteria in children's saliva?

Participants tasks:

  • Children were asked to chew gum containing Tulsi extract for 5 minutes and then dispose of the gum.
  • Two salivary samples were collected from each child: one before gum chewing and another 30 minutes after disposing the gum.

Researchers compared Streptococcus mutans counts in saliva before and after gum chewing to determine if there is a significant reduction in bacterial colonies.

详细描述

This interventional clinical trial aimed to assess the antimicrobial effect of Tulsi extract incorporated into chewing gum on the salivary Streptococcus mutans count in a group of children aged 4 to 11 years. The study enrolled 32 systemically healthy children who met specific criteria, including the absence of removable prosthetics or orthodontic appliances and no recent history of antibiotic use in the preceding 2 weeks.

Participants and Methods:

A sample of 33 children within the age range of 4 to 11 years was selected. The participants were systemically healthy, without removable prosthetics or orthodontic appliances, and had no recent history of antibiotic use in the previous 2 weeks. To standardize saliva collection conditions, samples were collected between 9-10 am in the morning. Children were instructed not to eat or drink anything (except water) 1 hour before saliva collection to maintain consistency in the samples.

Participants were then asked to spit into sterile containers as the method of saliva collection. Subsequently, they were instructed to masticate gum containing Tulsi extract for a duration of 5 minutes and discard the gum.

Two salivary samples were collected from each participant: one before commencing gum chewing and another 30 minutes after the conclusion of chewing gum for 5 minutes. The samples were streaked onto mitis salivarius agar plates and incubated at 37°C for 24 hours. Streptococcus mutans colonies were then counted to assess the change in bacterial count.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
4 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged between 4 and 12 years old.
  • No fixed or removable orthodontic appliances or removable prostheses.
  • Systemically healthy patients.
  • No history of recent antibiotic administration (previous 2 weeks).

排除标准

  • History of using antimicrobial mouthwash (previous 12 hours).
  • History of fluoride treatment (previous 2 weeks).

结局指标

主要结局

Salivary Streptococcus mutans Count

时间窗: Assessment will be conducted at two specific time points for each participant: Before commencing gum chewing, and after 30 minutes following the conclusion of chewing Tulsi Gum for 5 minutes...

The primary outcome measure involves assessing the count of Streptococcus mutans colonies in salivary samples. This count serves as a metric for evaluating the antimicrobial effect of Tulsi Gum on dental caries prevention in children.

次要结局

未报告次要终点

研究者

发起方
Faculty of Dental Medicine for Girls
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Somaya Mohsena Anwar

Pediatric Dentist

Faculty of Dental Medicine for Girls

研究点 (2)

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