| CTRI Number |
CTRI/2026/01/102133 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
27/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of two sugar-free herbal lollipops on oral hygiene in children aged 8–12 years |
|
Scientific Title of Study
|
Comparative Evaluation of the Effectiveness of Two Sugar-Free Herbal Lollipops in Promoting Oral Hygiene Among Children Aged 8–12 Years: A Randomized Controlled 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 |
Lakshika sree K V |
| Designation |
Post Graduate Student |
| Affiliation |
Chettinad Dental College and Research Institute |
| Address |
Rajiv Gandhi Salai
Kelambakkam
Chennai
TAMIL NADU
603103
India |
| Phone |
47413300 |
| Fax |
|
| Email |
lakshikadento@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Daya Srinivasan |
| Designation |
Professor and Head of the department |
| Affiliation |
Chettinad Dental College and Research Institute |
| Address |
Rajiv Gandhi Salai Kelambakkam
Chennai
TAMIL NADU
603103
India |
| Phone |
47413300 |
| Fax |
|
| Email |
dayaswathi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Lakshika Sree K V |
| Designation |
Postgraduate student |
| Affiliation |
Chettinad Dental College and Research Institute |
| Address |
Rajiv Gandhi Salai Kelambakkam
Chennai
TAMIL NADU
603103
India |
| Phone |
47413300 |
| Fax |
|
| Email |
lakshikadento@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rainbow Homes 45 school road ms colony jagannathapuram chetpet chennai tamilnadu india 600031 |
|
|
Primary Sponsor
|
| Name |
Lakshika Sree K V |
| Address |
E block Department of pedodontics chettinad dental college and research institute Rajiv gandhi salai kelambakkam Tamilnadu
India 603103 |
| 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 |
| VASUKI K V |
Rainbow homes |
45 school road MS colony jagannathapuram chetpet
Chennai
TAMIL NADU |
9444918987
kvvasuki31@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee Chettinad Dental College and Research Institute (IHEC-CDCRI) |
Approved |
| Institutional Human Ethics Committee Chettinad Dental College and Research Institute (IHEC-CDCRI) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy children |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Herbal lollipop |
Stevia plus moringa lollipop for 30 days |
| Comparator Agent |
Herbal lollipop |
Xylitol plus moringa lollipop for 30 days |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy children, whose parents
or caretakers provide consent to participate.
2. Children whose DMF less than two and caries risk
assessment of the child is mild to moderate |
|
| ExclusionCriteria |
| Details |
1. Children reporting allergy to the plant or any of
its constituents.
2. Children with a history of severe debilitating
diseases.
3. Children with a history of antibiotics for the past
3-4 weeks. |
|
|
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 |
| improvement in oral hygiene |
Baseline, day 15, day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in oral hygiene |
Baseline, day 15, day 30 |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
10/02/2026 |
| 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="0"
Months="0"
Days="30" |
|
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 randomized controlled trial aims to compare the effectiveness of two sugar-free herbal lollipops containing moringa with natural sweeteners stevia and xylitol in promoting oral hygiene among children aged 8–12 years. The study evaluates their impact on plaque accumulation, and salivary pH levels over 30 day intervention period. Children will be randomly allocated to receive either stevia-moringa or xylitol-moringa lollipops, consumed twice daily. Clinical and microbiological parameters will be assessed at baseline and follow-up visits. The study seeks to explore a novel, child-friendly, non-invasive preventive approach for improving oral health and reducing cariogenic microbial load. |