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临床试验/NCT06538532
NCT06538532已完成不适用

Effect of Zamzam Water on Streptococcus Mutans and Oral pH in High Caries-Risk Patients

Al-Azhar University2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2023年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
2
主要终点
Salivary PH level

研究概览

简要总结

The present study aims to evaluate and compare the effect of Zamzam water as mouthwashes in high caries-risk patients regarding:

i. Streptococcus mutans (S. mutans) count. ii. Oral pH. After 3 and 6 months interval.

详细描述

The present study aims to evaluate and compare the effect of Zamzam water mouthwashes in high caries-risk patients regarding:

i. Streptococcus mutans (S. mutans) count. ii. Oral pH. all patients will be into two groups; The first group will use Zamzam water mouthwash for a six months with other preventive protocols including fissure sealants and preventive restorations wherever needed, while the second group will undergo preventive protocols only. During these six months, patients will be reassessed at three and six-month intervals regarding S. mutans count, oral pH, and caries risk level.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female participants aged between 18-35 years.
  • Systemically- free individuals.
  • High caries-risk patients according to ADA (American Dental Association).
  • Not on a medication interfering with salivary secretion.
  • Co-operative patients approved to participate in the study.

排除标准

  • Patients who are already on any mouthwash regime.
  • Patients who are on any medication that would alter the salivary secretion.
  • Allergy to any of the ingredients of the study products.

结局指标

主要结局

Salivary PH level

时间窗: 3 months and 6 months

using pH meter

caries risk level

时间窗: 3 months and 6 months

According to ADA

Streptomutans count

时间窗: 3 months and 6 months

measurements of Colony forming unit (CFU) will be performed using blood agar and mitis salivarius-bacitracin agar (MSBA).

次要结局

未报告次要终点

研究者

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

Reham Youssef

Principal Investigator

Al-Azhar University

研究点 (2)

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