| CTRI Number |
CTRI/2026/02/102978 [Registered on: 04/02/2026] Trial Registered Prospectively |
| Last Modified On: |
23/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Other (Specify) [fennal seeds] |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparing the Effects of Different Fennel Seed Coatings on Oral Health |
|
Scientific Title of Study
|
Comparative evaluation of Salivary pH, flow rate and buffering capacity in adults consuming stevia-coated, sucrose-coated, honey-coated and roasted fennal seeds: A randomized crossover study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sakshi Mukesh Gujarathi |
| Designation |
PG student |
| Affiliation |
Sri Aurobindo College of Dentistry, Indore |
| Address |
Sri Aurobindo College of Dentistry,room no-14 department of public health dentistry,Indore
Indore
MADHYA PRADESH
453555
India |
| Phone |
7083305408 |
| Fax |
|
| Email |
smg240600@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sakshi Mukesh Gujarathi |
| Designation |
PG student |
| Affiliation |
Sri Aurobindo College of Dentistry, Indore |
| Address |
Sri Aurobindo College of Dentistry, room no 14- depart of public health dentistryIndore
Indore
MADHYA PRADESH
453555
India |
| Phone |
7083305408 |
| Fax |
|
| Email |
smg240600@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sakshi Mukesh Gujarathi |
| Designation |
PG student |
| Affiliation |
Sri Aurobindo College of Dentistry, Indore |
| Address |
Sri Aurobindo College of Dentistry, Indore room no 14 public health dentistry
Indore
MADHYA PRADESH
453555
India |
| Phone |
7083305408 |
| Fax |
|
| Email |
smg240600@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
sakshi gujarathi |
| Address |
DEPART MENT OF PUBLIC HEALTH DENTISTRY sri aurobindo college of dentistry |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrSakshi |
COLLEGE |
SRI AUROBINDO COLLEGE OF DENTISTRY room no 14- department of public health dentistry
Indore
MADHYA PRADESH |
9824002840
smg240600@gmail.com |
| sakshi |
public heath dentistry department |
saims
Indore
MADHYA PRADESH |
7083305408
gujarathisakshi2406@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SAIMS,indore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
20 natural teeth |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ROASTED FENNEL SEEDS |
of salivary pH, flow Rate, and buffering capacity in adults consuming stevia-coated, sucrose-coated, honey-coated and roasted fennel seeds: |
| Intervention |
WE WILL CHECK WETHER STEVIA IS NONCARIOGENIC OR NOT |
WE WILL COMAPRE of salivary pH, flow Rate, and buffering capacity in adults consuming stevia-coated, sucrose-coated, honey-coated and roasted fennel seeds: |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
60.00 Day(s) |
| Gender |
Both |
| Details |
1.Adults aged 18 and above.
2.Individuals with a minimum of 20 natural teeth.
3.Subjects with good general health without any systemic conditions.
4.Willingness to provide written informed consent
|
|
| ExclusionCriteria |
| Details |
1.Individuals with a history of xerostomia or reduced salivary flow.
2.Presence of any active dental caries, periodontal disease, or oral infections.
3.Participants using salivary stimulants, chewing gum, or other oral health products that could affect salivary pH.
4.History of allergic reactions to fennel seeds, stevia, honey, or sucrose.
5.Individuals undergoing orthodontic treatment or with removable prosthetics.
6.Pregnant or lactating women.
7.Participants with systemic disease and under medication for same.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The main outcome of the study was to see how salivary pH (acidity of saliva) changes over time after eating different types of fennel seeds. |
BASLEINE, 3rd DAY, 5th DAY, 7th DAY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| salivary flow rate and buffering capacity |
60 min |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="16" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/02/2026 |
| Date of Study Completion (India) |
07/03/2026 |
| Date of First Enrollment (Global) |
16/02/2026 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
“This study was conducted to evaluate the effect of fennel (Foeniculum vulgare) on oral health among patients attending dental OPD. The aim of the study was to assess the impact of fennel on oral health parameters. This interventional study was carried out among participants selected based on inclusion and exclusion criteria. Participants were instructed to use fennel regularly, and outcomes were assessed using a structured assessment method. Statistical analysis was performed to evaluate the results. The findings of this study are expected to provide a simple and cost-effective approach for improving oral health.” |