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临床试验/CTRI/2025/01/079024
CTRI/2025/01/079024
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Post Marketing Surveillance

Comparative evaluation of Herbal, Chlorine dioxide and Probiotic based mouthwashes on reduction of biofilm in 6-12 years old children: An Invivo study

Dr. Shaik Salma1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年2月3日最近更新:

概览

阶段
Post Marketing Surveillance
状态
已完成
发起方
Dr. Shaik Salma
入组人数
60
试验地点
1
主要终点
Sillness and Loe Plaque Index

概览

简要总结

Oral hygiene practices that intervene with plaque formation play a crucial role in preventing dental caries. Raising concerns of toxicity with conventional mouthwash usage led to the search for biologically safe mouth rinsing agents in children. The present study aims to evaluate the efficacy of Herbal (Botanical Oral rinse) and Stabilized Chlorine Dioxide (ClO2) mouth wash in beneficially altering the oral ecological niche in children aged 6-12 years. Prior to intervention, the plaque accumulation will be assessed using Sillness and Loe Plaque index and unstimulated saliva samples will be collected to quantify S. mutans  as a baseline data. The children will then be instructed to rinse the allocated mouthwash once daily for 60 sec for 14 days and fill the supplied checklist . The assessment of all the parameters will be repeated after 14 days of intervention and the values will be subjected to statistical analysis.

研究设计

研究类型
Pms
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Investigator Blinded

入排标准

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

入选标准

  • Children within the age range of 6-12 years.
  • Children with DMFT score ≤ 2 3)Children with no history of antibiotic or probiotics in any form in the past three months.

排除标准

  • Medically compromised children 2)Children with history of systemic allergies and diseases.
  • Children using any prosthodontic/orthodontic appliance.

结局指标

主要结局

Sillness and Loe Plaque Index

时间窗: Pre evaluation(baseline plaque scores will be assessed) After 14 days of intervention, post evaluation of plaque scores will be assessed.

次要结局

  • s.mutans bacterial load(pre evaluation(baseline s.mutans count on Day 0) & After 14 days of intervention, post evaluation of s.mutans count (Day 15))

研究者

发起方
Dr. Shaik Salma
申办方类型
Other [Self supported study]
责任方
Principal Investigator
主要研究者

Dr Shaik Salma

GITAM Dental College and Hospital

研究点 (1)

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