| CTRI Number |
CTRI/2015/10/006305 [Registered on: 26/10/2015] Trial Registered Prospectively |
| Last Modified On: |
20/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to compare effect of licorice, fluoride and combination of both on early stage of tooth decay in 3-4 year old preschool children.
|
|
Scientific Title of Study
|
Effectiveness of Licorice varnish, Fluoride varnish and Combination of Both, on Incipient Lesions of Early Childhood Caries in 3-4 year old preschool children of Belgaum city- A randomized controlled trial
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Roopali Sankeshwari |
| Designation |
Reader |
| Affiliation |
KLEVK Institute of dental sciences |
| Address |
Department of Public Health Dentistry
KLEVK Institute of dental sciences
Belgaum
Nehru nagar
Department of Public Health Dentistry
KLEVK Institute of dental sciences
Belgaum
Nehru nagar
Belgaum
KARNATAKA
590010
India |
| Phone |
9844837197 |
| Fax |
08312470640 |
| Email |
docrups@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil V Ankola |
| Designation |
Prof and head |
| Affiliation |
KLEVK Institute of dental sciences |
| Address |
Department of Public Health Dentistry
KLEVK Institute of dental sciences
Belgaum
Nehru nagar
Department of Public Health Dentistry
KLEVK Institute of dental sciences
Belgaum
Nehru nagar
Belgaum
KARNATAKA
590010
India |
| Phone |
9343434455 |
| Fax |
08312470640 |
| Email |
drankola@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Roopali Sankeshwari |
| Designation |
Reader |
| Affiliation |
KLEVK Institute of dental sciences |
| Address |
Department of Public Health Dentistry
KLEVK Institute of dental sciences
Belgaum
Nehru nagar
Staff qtrs no 14/11 JNMC Campus, Nehrunagar
KARNATAKA
590010
India |
| Phone |
9844837197 |
| Fax |
08312470640 |
| Email |
docrups@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Roopali Sankeshwari |
| Address |
Department of Public Health Dentistry
KLEVK Institute of dental sciences
Belgaum
Nehru nagar 590010
|
| Type of Sponsor |
Other [] |
|
|
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 Roopali Sankeshwari |
Randomly selected private and public preschools of Belgaum |
Belgaum city
Belgaum
KARNATAKA |
9844837197
docrups@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ph.D Ethical committee (Human) KLE University Belgaum |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
initial dental caries |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fluoride varnish |
0.5 ml varnish will be applied every 3 months at 0,3,6 and 9th month |
| Intervention |
Licorice varnish, combination of fluoride and licorice varnish |
0.5 ml varnish will be applied every 3 months at 0,3,6 and 9th month |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
4.00 Year(s) |
| Gender |
Both |
| Details |
• Child with at least one initial caries lesion as per Nyvad classification.
• Children with dental caries experience (dmft score) in the range of 3-6.
|
|
| ExclusionCriteria |
| Details |
• Children with any GIC restorations, pit and fissure sealants.
• Developmental alterations like hypoplasia or fluorosis.
• Use of orthodontic device or appliance.
• Being under medical treatment or taking any kind of medication and
• Parents not willing to give consent. |
|
|
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 Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Remineralization of initial caries – Minimum 4 points change in diagnodent score
• Change in salivary Streptococcus mutans count before and after the intervention at the end of 1 year.
|
• at the end of 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="195"
Sample Size from India="195"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/12/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="5"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, single blind parallel group trial comparing the effectiveness of Licorice varnish, fluoride varnish and the combination of both on initial lesions of Early childhood caries in 3-4 year old preschool children of Belgaum city. The primary outcome measures will be Remineralization of initial dental carious lesions and change in Salivary Streptococcus mutans count after 12 months. Research hypothesis would be that the effect of licorice varnish on initial carious lesions would be non inferior to the effect of fluoride varnish. Varnishes would be applied on randomly selected preschool children at baseline,3rd , 6th,9th month respectively. Diagnodent instrument would be used to measure the extent of changes in the demineralized lesion after the intervention. |