| CTRI Number |
CTRI/2026/02/104782 [Registered on: 25/02/2026] Trial Registered Prospectively |
| Last Modified On: |
24/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study on Two Fluoride Treatments to Keep Children’s Teeth Healthy |
|
Scientific Title of Study
|
COMPARATIVE ASSESSMENT OF CONVENTIONAL AND ARGININE ENRICHED FLUORIDE VARNISHES ON CARIES INCREMENT, SALIVARY FLUORIDE ION CONCENTRATION AND ORAL MICROBIAL PROFILE : AN INVIVO 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 |
Dr Balasubramani |
| Designation |
Post graduate |
| Affiliation |
Rajarajeswari Dental College and Hospital Bangalore |
| Address |
Rajarajeswari Dental College and Hospital , Room no-6 Department of pediatric and preventive dentistrty . No.14, Ramohalli Cross, Mysore road,
Kumbalgodu, Bengaluru, Karnataka 560074
Bangalore Rural
KARNATAKA
560074
India |
| Phone |
8971842257 |
| Fax |
|
| Email |
bala_vk11@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amrutha ujjamma B |
| Designation |
Reader |
| Affiliation |
Rajarajeswari Dental College and Hospital Bangalore |
| Address |
Rajarajeswari Dental College and Hospital , Room no-6 Department of pediatric and preventive dentistrty . No.14, Ramohalli Cross, Mysore road,
Kumbalgodu, Bengaluru, Karnataka 560074
Bangalore Rural
KARNATAKA
560074
India |
| Phone |
8105700221 |
| Fax |
|
| Email |
amrutha.b87@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Balasubramani |
| Designation |
Post graduate |
| Affiliation |
Rajarajeswari Dental College and Hospital Bangalore |
| Address |
Rajarajeswari Dental College and Hospital , Room no-6 Department of pediatric and preventive dentistrty . No.14, Ramohalli Cross, Mysore road,
Kumbalgodu, Bengaluru, Karnataka 560074
Bangalore Rural
KARNATAKA
560074
India |
| Phone |
8971842257 |
| Fax |
|
| Email |
bala_vk11@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| RajaRajeswari Dental College and Hospital ,room no 6 Department of Pediatric and Preventive Dentistry ,No.14, Ramohalli Cross, Mysore Roa Bengaluru, Karnataka 560074
|
|
|
Primary Sponsor
|
| Name |
Dr Balasubramani |
| Address |
Rajarajeswari Dental College and Hospital , Room no-6 Department of pediatric and preventive dentistrty . No.14, Ramohalli Cross,
Kumbalgodu, Bengaluru, Karnataka 560074 |
| Type of Sponsor |
Other [Self funded] |
|
|
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 Balasubramani |
Rajarajeswari Dental College and Hospital |
Room no-6, Department of pediatric and preventive dentistrty, No.14, Ramohalli Cross, Mysore Road, Kumbalgodu, Bengaluru,
Karnataka 560074
Bangalore Rural
KARNATAKA |
8971842257
bala_vk11@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajarajeswari Dental College Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Good general health, no systemic diseases affecting saliva or oral health. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
2%L-Arginine enriched MI varnish |
200mg of L-arginine will be mixed with 10ml of MI varnish. To assure the homogenous incorporation the mixture will be sonicated for 10min using an ultrasonic sonicator probe.
40 patients will undergo single application at baseline. 2%L-Arginine enriched MI varnish will be applied evenly to the buccal and palatal surfaces of all teeth using a microbrush. |
| Comparator Agent |
MI Varnish |
40 patients will undergo single application at baseline. MI varnish will be applied evenly to the buccal and palatal surfaces of all teeth using a microbrush.
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1.Children within 6-10 years of age of both the genders
2.Children at risk with 2 or more carious teeth.
3.Co-operative behavior (Frankl scale rating 3-4).
4.Good general health, no systemic diseases affecting saliva or oral health.
|
|
| ExclusionCriteria |
| Details |
1.Allergies to fluoride, arginine or varnish components.
2.Children requiring special health care needs.
3.Pulpally involved and grossly decayed teeth
4.Professional fluoride application, antibiotics or fluoride supplements within 3 months prior.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Caries Increment measured using ICDAS II score
|
Baseline and 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Salivary Fluoride Ion Concentration measured using UV Spectrophotometry (SPADNS method).
Streptococcus mutans Count cultured on Mitis-Salivarius-Bacitracin agar media and measured. |
Baseline, 1 month and 3 month |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
17/08/2026 |
| 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="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
|
The present study will be done on 80 children aged 6-10 years who
meets the inclusion criteria and will be distributed randomly into two groups
as follows.
Group I (n=40): Children
treated with MI varnish.
Group II (n=40): Children treated with 2%L-Arginine enriched MI
varnish.
BASELINE:
All Patients will be instructed to refrain from eating and drinking
for 1 hour before the saliva sample collection. Then the patients will be made
to rinse the mouth with water and to
swallow the preexisting saliva. Baseline saliva sample will be collected from
the floor of mouth using disposable syringe to avoid any possible contamination
and is injected into Eppendorf tubes with buffer solution and refrigerated at
-20 degree Celsius and stored in laboratory until further analysis. Tooth
surface will be cleaned with sterile gauze and air dried. A thorough clinical
examination using ICDAS II score will be done by a single evaluator using a
dental mirror and probe with a blunt end on the dental chair with optimal light
for both the groups. Saliva samples will be subjected for fluoride ion
concentration estimation using UV spectrophotometry analysis (SPADNS Method) and
cultured on selective Mitis-Salivarius-Bacitracin (MSB) agar media for
Streptococcus mutans count.
INTERVENTION:
Patients in the group I will
be treated with MI varnish and group II
will be treated with 2%L-Arginine enriched MI varnish. The varnish will be
applied evenly to the buccal and palatal surfaces of all teeth using a
microbrush and allowed to remain undisturbed for five minutes. Patients will be
instructed to refrain from consuming food or rinsing for 2h. They will be
advised to avoid hard or sticky food for 4h post-treatment.
POST INTERVENTION:
Patients will be recalled after 1 month and 3 month from the day of
application and post -intervention saliva samples will be collected by same
procedure as mentioned above and all the samples will be subjected for fluoride
ion concentration estimation using UV spectrophotometry analysis (SPADNS
Method) and cultured on selective Mitis-Salivarius-Bacitracin (MSB) agar media
for Streptococcus mutans count. And at 6 month follow up, ICDAS II scoring will
be recorded. The results obtained will be subjected to statistical analysis.
|