| CTRI Number |
CTRI/2025/07/091844 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
26/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Studying how Green Tea, Chamomile Tea, and Moringa Tea affect cavity-causing bacteria in the saliva of young adults |
|
Scientific Title of Study
|
Evaluating the antibacterial effects of widely available Green tea, Chamomile tea and Moringa tea on salivary Streptococcus Mutans Level: An in vivo 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 |
Paras |
| Designation |
Undergraduate |
| Affiliation |
Faculty of Dental Sciences, SGT University, Gurugram |
| Address |
room no 204, Department of Conservative Dentistry and Endodontics, Faculty of dental Sciences, SGT University
Gurgaon HARYANA 122001 India |
| Phone |
8607517787 |
| Fax |
|
| Email |
paraskk1311@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Akanksha Joon |
| Designation |
Assistant Professor |
| Affiliation |
Faculty of Dental Sciences, SGT University, Gurugram |
| Address |
room no 204, Department of Conservative Dentistry and Endodontics, Faculty of dental Sciences, SGT University
Gurgaon HARYANA 122001 India |
| Phone |
9971167340 |
| Fax |
|
| Email |
joonakanksha@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Akanksha Joon |
| Designation |
Assistant Professor |
| Affiliation |
Faculty of Dental Sciences, SGT University, Gurugram |
| Address |
room no 204, Department of Conservative Dentistry and Endodontics, Faculty of dental Sciences, SGT University
Gurgaon HARYANA 122001 India |
| Phone |
9971167340 |
| Fax |
|
| Email |
joonakanksha@gmail.com |
|
|
Source of Monetary or Material Support
|
| No external monetary or material support. The study will be self funded by the Principal Investigator and conducted using the internal resources at SGT University, Gurugram |
|
|
Primary Sponsor
|
| Name |
SGT University Gurugram |
| Address |
SGT University
Chandu-Budhera, Gurugram-Badli Road
Budhera, Gurugram – 122505
Haryana, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Akanksha Joon |
SGT University |
Room no. 204, Department of Conservative Dentistry and Endodontics, Faculty of Dental Sciences, SGT University, Budhera, Gurugram Gurgaon HARYANA |
9971167340
joonakanksha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe SGT Dental College Hospital and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K026||Dental caries on smooth surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Chamomile Tea Group |
1 tea bag in 1 cup of boiling water, consumed once daily after breakfast |
| Comparator Agent |
Chlorhexidine Gluconate 0.2% Mouthwash |
10 mL twice daily after brushing |
| Intervention |
Green Tea (Camellia sinensis) |
1 tea bag in 1 cup of boiling water, consumed once daily after breakfast |
| Intervention |
Moringa Tea Group |
1 tea bag in 1 cup of boiling water, consumed once daily after breakfast |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants not consuming these herbal tea prior to study.
2.Not associated with any systemic disease.
3.No history of receiving fluoride mouthwash or varnish for at least one month before sampling
|
|
| ExclusionCriteria |
| Details |
1.Those undergoing antibiotic therapy.
2.Presence of rampant caries, soft tissue lesions, and localized/ generalized active periodontitis.
3.History of usage of any medication or antimicrobial mouthwash like CHG and participants who had prosthetic-orthodontic appliances.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of this study is the change in the salivary Streptococcus mutans count from baseline to post-intervention, measured quantitatively after the participants have consumed the assigned tea intervention for the specified study duration. |
Baseline (Day 0 – before intervention)
1 Week post-intervention
1 Month post-intervention
6 Months post-intervention
1 Year post-intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
01/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" 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
|
This in vivo study aims to evaluate and compare the antibacterial effects of three commonly available herbal teas—Green tea, Chamomile tea, and Moringa tea in comparison to Chlorhexidine gluconate on the salivary levels of Streptococcus mutans, a primary contributor to dental caries. Healthy participants will be randomly assigned to one of the four intervention groups each consuming a specified quantity of the assigned tea daily over a fixed period. Unstimulated saliva samples will be collected at baseline and post-intervention to quantify changes in S. mutans using qPCR (Real time Polymerase chain reaction) technique for each participant. . The study seeks to identify which of the three herbal teas demonstrates the most effective reduction in salivary S. mutans levels, potentially contributing to the development of natural, preventive oral health strategies. |