| CTRI Number |
CTRI/2025/06/089391 [Registered on: 23/06/2025] Trial Registered Prospectively |
| Last Modified On: |
19/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic
Dentistry
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study on the Impact of a Nutraceutical Supplement on Oral Health and Microbiota in Children |
|
Scientific Title of Study
|
A Multi-Center Open-label Interventional Pilot Clinical Study to Evaluate the Effectiveness of a Nutraceutical Formulation Containing Phosphatidylserine Probiotics Essential Oils and DHA in Improving Oral Microbiota and Overall Oral Health in Children. |
| 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 Lakshmi Balraj |
| Designation |
Chief officer and Head Reseach |
| Affiliation |
Indian Dental Association |
| Address |
3rd Floor Unit No 3A and B Zone 1
DGP House 88 C Old Prabhadevi Road
Prabhadevi Worli
Mumbai
Maharashtra
India
Mumbai
MAHARASHTRA
400025
India |
| Phone |
9742504911 |
| Fax |
|
| Email |
drlakshmi@idrf.org.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lakshmi Balraj |
| Designation |
Chief officer and Head Reseach |
| Affiliation |
Indian Dental Association |
| Address |
3rd Floor Unit No 3A and B Zone 1
DGP House 88 C Old Prabhadevi Road
Prabhadevi Worli
Mumbai
Maharashtra
India
Mumbai
MAHARASHTRA
400025
India |
| Phone |
9742504911 |
| Fax |
|
| Email |
drlakshmi@idrf.org.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Janhvi Bhole |
| Designation |
Research Coordinator |
| Affiliation |
Indian Dental Association |
| Address |
3rd Floor Unit No 3A and B Zone 1
DGP House 88 C Old Prabhadevi Road
Prabhadevi Worli
Mumbai
Maharashtra
India
Mumbai
MAHARASHTRA
400025
India |
| Phone |
7774917372 |
| Fax |
|
| Email |
janhvibhole.ida@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lasarkaali Life Sciences Pvt Ltd
Plot No 3-97, opp. to CGR International School,
Ayyappa Society, Chanda Naik Nagar, Madhapur,
Hyderabad, Telangana 500081
|
|
|
Primary Sponsor
|
| Name |
Lasarkaali Life Sciences Pvt Ltd |
| Address |
Plot No 3 97 opp. to CGR International School
Ayyappa Society Chanda Naik Nagar Madhapur
Hyderabad Telangana 500081
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrSushma Gojanur |
K.D. Dental College and Hospital |
Room 201, Department of Pedodontics and Preventive Dentistry, Division Dental, K.D. Dental College and Hospital Mathura Delhi Mathura Road National Highway 19 Post Office Chhatikara Mathura 281003 Uttar Pradesh
Mathura
UTTAR PRADESH |
9837230109
drsushmagojanur@yahoo.com |
| Dr E Sridevi |
Sibar Institute of Dental Sciences |
Room 221 Department of Pedodontics and Preventive Dentistry Division Dental Sibar Institute of Dental Sciences
Takkellapadu Guntur 522509
Andhra Pradesh
Guntur
ANDHRA PRADESH |
7799239108
drsridevi2009pedo@sids.ac.in |
| Dr Komal Nanaware |
Sinhgad dental college and hospital |
Room 334 Department of Pedodontics and Preventive Dentistry Division Dental Sinhgad dental college and hospital
Vadgaon bk
Pune 411041
Pune
MAHARASHTRA |
9673097278
komalnanaware@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Sinhgad dental college and hospital |
Approved |
| Institutional ethics committee, K.D. Dental College and Hospital |
Approved |
| Institutional ethics committee, SIBAR institute of dental sciences. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Plaque and Calculus in oral cavity |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hetafu Functional Candy |
Participants(ages 5–14) will receive a fixed dosage of 2 candies per day for 6 weeks i.e 42 days |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Healthy male and female subjects aged 5–14 years.
No history of severe periodontal disease, recurrent oral infections, or advanced dental caries requiring medical intervention.
No use of antibiotics, antifungal agents, or strong antiseptic mouthwashes within 30 days prior to study enrollment.
Willing to maintain regular oral hygiene practices during the study.
|
|
| ExclusionCriteria |
| Details |
History of severe oral disease requiring medical intervention.
Use of antibiotics, antifungal agents, or strong antiseptic mouthwashes within 30 days before screening.
Pregnant or lactating women.
Known allergy to any ingredient in the Nutraceutical Formulation.
Diagnosed gastrointestinal disorders that may interfere with probiotic absorption.
Individuals currently enrolled in another clinical trial.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Streptococcus mutans and Lactobacillus acidophilus levels from baseline to Week 6. |
At Week 6 Last microbiota sampling will be done i.e at 3rd follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the reduction in halitosis over 6 weeks using a questionnaire. (based on the perception of the subject).
|
At Week 6 a questionaire will be given to the patient i.e at 3rd follow up |
| To measure improvements in gingival health as assessed by Gingival Index scores. |
At Week 6 gingival scores will be taken again i.e at 3rd follow up |
| To analyze microbial balance shifts that reduce harmful bacterial strains like Streptococcus mutans and Lactobacillus acidophilus |
At Week 6 Last microbiota sampling will be done i.e at 3rd follow up |
|
|
Target Sample Size
|
Total Sample Size="225"
Sample Size from India="225"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
14/07/2025 |
| 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="0"
Months="1"
Days="12" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 is a Pilot, open-label, multi-center, interventional clinical trial designed to evaluate the effectiveness of a nutraceutical formulation in improving oral microbiota balance and overall oral health in children aged 5 to 14 years. A total of 225 participants will be enrolled across three clinical sites. Subjects will receive a fixed dose of two functional probiotic-based candies per day for 42 days. The primary endpoint is the reduction in Streptococcus mutans and Lactobacillus acidophilus levels, assessed through agar culture methodology. Secondary endpoints include improvements in gingival health, reduction in halitosis, and evaluation of product safety and tolerability. The study aims to generate preliminary efficacy and safety data for this formulation as a supportive oral health supplement for pediatric use. |