| CTRI Number |
CTRI/2024/05/067132 [Registered on: 09/05/2024] Trial Registered Prospectively |
| Last Modified On: |
09/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of sweet basil varnish on Dental caries |
|
Scientific Title of Study
|
Comparative evaluation of anticariogenic efficacy of
Ocimum basilicum varnish and fluoride varnish
among 6 to 8 years old school children: A double-blind 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 |
Dr Siva Shankkari T |
| Designation |
Postgraduate student |
| Affiliation |
KAHERS KLE VK Institute of dental sciences |
| Address |
Department number 2, Public Health Dentistry, Ground floor, KAHERS KLE VK Institute of Dental Sciences, JNMC campus, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9600473499 |
| Fax |
|
| Email |
sivashankkarit@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Siva Shankkari T |
| Designation |
Postgraduate student |
| Affiliation |
KAHERS KLE VK institute of dental sciences |
| Address |
Department number 2, Public Health Dentistry, Ground floor, KAHERS KLE VK Institute of Dental Sciences, JNMC campus, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9600473499 |
| Fax |
|
| Email |
sivashankkarit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anil V Ankola |
| Designation |
Professor and Head |
| Affiliation |
KAHERS KLE VK institute of dental sciences |
| Address |
Department number 2, Public Health Dentistry, Ground floor, KAHERS KLE VK Institute of Dental Sciences, JNMC campus, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9343434455 |
| Fax |
|
| Email |
dranilankola@kledental-bgm.edu.in |
|
|
Source of Monetary or Material Support
|
| Department number 2, Public Health Dentistry, Ground floor, KAHERS KLE VK Institute of Dental Sciences, JNMC campus, Nehru Nagar, Belagavi |
|
|
Primary Sponsor
|
| Name |
Dr Siva Shankkari T |
| Address |
Department number 2, Public Health Dentistry, Ground floor, KAHERS KLE VK Institute of Dental Sciences, JNMC campus, Nehru Nagar, Belagavi |
| 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 Siva Shankkari |
Government school |
Class II, section A,Ground floor,Government primary school, Kakati, Belagavi,Karnataka
Pincode:591113
Belgaum
KARNATAKA |
9600473499
sivashankkarit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Government primary school,Kakati |
No Objection Certificate |
| Institutional Research and ethics committee KLE VKIDS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Commercially available Fluoride varnish |
Isolation of teeth will be done with cotton rolls and 0.1 ml of prepared varnish will be applied on the surface of teeth using cotton pellets and dried for 25 seconds at baseline,4th week and 12th week |
| Intervention |
Ocimum basilicum dental varnish |
Isolation of teeth will be done with cotton rolls and 0.1 ml of prepared varnish will be applied on the surface of teeth using cotton pellets and dried for 25 seconds at baseline,4th week and 12th week |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1. Children with atleast one
initial enamel caries as per
ICDAS scoring in age group
of 6-8 years.
2. Parents/guardians who are
willing to give written consent |
|
| ExclusionCriteria |
| Details |
1. Teeth with any GIC restorations, pit
and fissure sealants.
2. Development alterations like
hypoplasia or fluorosis.
3. Children with any other
systemic/psychological conditions.
4. Children with any history of allergy
reactions to the herbal medicaments or
varnish.
5. Children under medical treatment or taking
medication in any form.
6. Children unwilling to complete the
treatment protocol.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of ICDAS score and Plaque Streptococcus mutans count |
Baseline and 4 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
24/05/2024 |
| 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="4"
Days="0" |
|
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
|
Topical fluoride has been widely used in preventing dental caries. However, its deleterious effects on dental, skeletal, cardiovascular, gastrointestinal and neurological tissues emphasize on the need of an alternative dental varnish which is safe and biocompatible. Recent approaches in modern medicine aim to derive ingredients from nature as they are organic, biocompatible and less expensive. In this study, Ocimum basilicum seeds commonly called as ‘Sweet basil†are used for formulation of a herbal varnish as they are rich source of calcium and phosphorous and possess antibacterial properties. Dental caries is considered as the most important global oral health burden affecting 60-90% of school-aged children with 78% of prevalence in India. Poor oral health in children leads to poor development due to malnutrition and affects overall general health. In this study, 6-8 year old children are included as this age group falls in the second window of infectivity making them more susceptible to caries. Thus, it is the need of the hour for a non-toxic, economical and herbal dental varnish to prevent dental caries from an early age. |