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Clinical Trials/CTRI/2025/09/094561
CTRI/2025/09/094561
Not yet recruiting
Not Applicable

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 site in 1 country42 target enrollmentStarted: December 1, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Dr Shubhashree Gandhe
Enrollment
42
Locations
1
Primary Endpoint
Antimicrobial Efficacy of 50% Foeniculum vulgare mouthwash against Streptococcus mutans

Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
17.00 Year(s) to 25.00 Year(s) (—)
Sex
All

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Antimicrobial Efficacy of 50% Foeniculum vulgare mouthwash against Streptococcus mutans

Time Frame: 21 days

Secondary Outcomes

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

Investigators

Sponsor
Dr Shubhashree Gandhe
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Shubhashree Gandhe

SMBT IDSR

Study Sites (1)

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