| CTRI Number |
CTRI/2025/09/094561 [Registered on: 11/09/2025] Trial Registered Prospectively |
| Last Modified On: |
17/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of Fennel Seed Mouthwash Against Streptococcus mutans: A Natural Alternative to Chlorhexidine |
|
Scientific Title of Study
|
Comparative Evaluation of the Antimicrobial Efficacy of 50% Foeniculum vulgare mouthwash and 0.2% Chlorhexidine mouthwash on Streptococcus mutans : A Randomised Control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shubhashree Gandhe |
| Designation |
Post Graduate Student |
| Affiliation |
SMBT IDSR |
| Address |
SMBT IDSR,Nandi Hills, Dhamangaon,Igatpuri, District, Nashik. Department of
pedodontics Room number 302
Nashik
MAHARASHTRA
422403
India |
| Phone |
9607360464 |
| Fax |
|
| Email |
shubhashreegandhe4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pranav Dave |
| Designation |
Reader and PG Guide |
| Affiliation |
SMBT IDSR |
| Address |
SMBT IDSR,Nandi Hills, Dhamangaon,Igatpuri, District, Nashik. Department of
pedodontics Room number 302
Nashik
MAHARASHTRA
422403
India |
| Phone |
9082060919 |
| Fax |
|
| Email |
dr.pranav.dave@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubhashree Gandhe |
| Designation |
Post Graduate Student |
| Affiliation |
SMBT IDSR |
| Address |
SMBT IDSR,Nandi Hills, Dhamangaon,Igatpuri, District, Nashik. Department of
pedodontics Room number 302
Nashik
MAHARASHTRA
422403
India |
| Phone |
9607360464 |
| Fax |
|
| Email |
shubhashreegandhe4@gmail.com |
|
|
Source of Monetary or Material Support
|
| SMBT IDSR,Nandi Hills, Dhamangaon Tal., Igatpuri, Dist, Nashik, Maharashtra
422403 |
|
|
Primary Sponsor
|
| Name |
Dr Shubhashree Gandhe |
| Address |
SMBT IDSR,Nandi Hills, Dhamangaon Tal., Igatpuri, Dist, Nashik, Maharashtra
422403 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shubhashree Gandhe |
SMBT Institute of Dental Sciences and Research |
SMBT Institute of Dental Sciences and Research,Nandi Hills, Dhamangaon,Igatpuri, District, Nashik. Department of Pediatric and Preventive Dentistry,Room number 302.
Nashik
MAHARASHTRA |
09607360464
shubhashreegandhe4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMBT IDSR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Systemically healthy individuals.
Patients should not have Cellulitis, abscess, draining sinus, or other emergency dental treatment.
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.2% Chlorhexidine mouthwash |
0.2% Chlorhexidine mouthwash will be given and its antimicrobial efficacy againt Streptococcus mutans will be checked after 21 days. |
| Intervention |
50% Foeniculum vulgare mouthwash |
50% Foeniculum vulgare mouthwash will be given and its antimicrobial efficacy againt Streptococcus mutans will be checked after 21 days. |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
First-year undergraduate dental students.
Systemically healthy individuals.
|
|
| ExclusionCriteria |
| Details |
History of current or past 1-month antibiotic usage.
Cellulitis, abscess, draining sinus, or other emergency dental treatment. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Antimicrobial Efficacy of 50% Foeniculum vulgare mouthwash against Streptococcus mutans |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To check the antimicrobial efficacy of herbal mouthwash over allopathic mouthwash |
21 days |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/12/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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.
|
|
|