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临床试验/CTRI/2025/09/094561
CTRI/2025/09/094561尚未招募不适用

Comparative Evaluation of the Antimicrobial Efficacy of 50% Foeniculum vulgare mouthwash and 0.2% Chlorhexidine mouthwash on Streptococcus mutans : A Randomised Control Trial

Dr Shubhashree Gandhe1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2025年12月1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
42
试验地点
1
主要终点
Antimicrobial Efficacy of 50% Foeniculum vulgare mouthwash against Streptococcus mutans

研究概览

简要总结

First year undergraduates will be
selected as patient.

Patient will be explained about the procedure and its outcome. Healthy patients will be selected and randomly divided into two groups as Group A and Group B using Computer generated Randomized sequence.

GROUP A : Patients administered with Foeniculum vulgare (Funnel seed) mouthwash  .

GROUP B : Patient administered with Chlorhexidine mouthwash.

Double blinding will be conducted that is both the participant and the clinical evaluator will be blinded .

A third party
keeps the allocation key (which mouthwash corresponds to which code).

Unblinding occurs only after data collection and statistical analysis — or earlier only if adverse events require it. Salivary sample of 2 mL will be collected in a sterile plastic bottle

The samples will be tested for the microbiological analysis for the colony-forming units (CFU) of S. mutans.

Patient of both the group will be advised to rinse their mouth for 1 minute using 5 mL of the mouthwash daily. The second sample will be taken only after 21 days after using mouthwashes and counted for colonies.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
17.00 Year(s) 至 25.00 Year(s)(—)
性别
All

入选标准

  • First-year undergraduate dental students.
  • Systemically healthy individuals.

排除标准

  • History of current or past 1-month antibiotic usage.
  • Cellulitis, abscess, draining sinus, or other emergency dental treatment.

结局指标

主要结局

Antimicrobial Efficacy of 50% Foeniculum vulgare mouthwash against Streptococcus mutans

时间窗: 21 days

次要结局

  • To check the antimicrobial efficacy of herbal mouthwash over allopathic mouthwash(21 days)

研究者

发起方
Dr Shubhashree Gandhe
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Shubhashree Gandhe

SMBT IDSR

研究点 (1)

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