| CTRI Number |
CTRI/2025/01/078966 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Determine the Effect of Flouride varnish On White spot lesion using Carbonic Anhydrase Concentration and Activity |
|
Scientific Title of Study
|
Effect of Fluoride Varnish On White Spot Lesions Using Salivary Carbonic Anhydrase VI in Preschool 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 |
Reshma James |
| Designation |
postgraduate student |
| Affiliation |
Rajarajeswari Dental College and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry
Rajarajeswari dental college and hospital ,Kumbalgodu
banglore
pin 560074 Department of Pediatric and Preventive DentistrRajarajeswari dental college and hospital ,Kumbalgodu
banglore
pin 560074 Bangalore KARNATAKA 560074 India |
| Phone |
8111828079 |
| Fax |
|
| Email |
reshmajames96@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Nagaratna C |
| Designation |
Senior Professor |
| Affiliation |
Rajarajeswari Dental College and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry
Rajarajeswari dental college and hospital ,Kumbalgodu
banglore ,Karnataka India
pin 560074
Bangalore KARNATAKA 560074 India |
| Phone |
8111828079 |
| Fax |
|
| Email |
shanraatna@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Reshma James |
| Designation |
post graduate student |
| Affiliation |
Rajarajeswari Dental College and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry
Rajarajeswari dental college and hospital ,Kumbalgodu
banglore
pin 560074 banglore Bangalore KARNATAKA 560074 India |
| Phone |
8111828079 |
| Fax |
|
| Email |
reshmajames96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajarajeswari Dental college and Hospital ,Kumbalgodu, Banglore
PIN 560074
Karnataka
India |
|
|
Primary Sponsor
|
| Name |
Reshma James |
| Address |
Rajarajeswari dental college and hospital,Kumbalgodu
Banglore Pin 560074
Karnataka
India |
| Type of Sponsor |
Other [Reshma James] |
|
|
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 |
| Reshma james |
Rajarajeswari dental college and hospital |
Deparment of Pediatric and Preventive Dentistry ,Kumbalgodu
banglore
Karnataka
India
pin 560074
Bangalore KARNATAKA |
8111828079
reshmajames96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajarajeswari Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
children with white spot lesions on teeth |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Biflouride varnish |
single drop application biflouride varnish containing sodium fluoride and calcium fluoride using applicator tip on the teeth surface for one week |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
healthy children with active white spot lesions |
|
| ExclusionCriteria |
| Details |
children with special health care needs
children who received remineralizing agents i past 3 months |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| determine carbonic anhydrase concentration, activity after the application of Flouride varnish in white spot lesions |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| remineralization of white spot lesions |
7 days |
|
|
Target Sample Size
|
Total Sample Size="25" Sample Size from India="25"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
29/01/2025 |
| 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="6" 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
|
Caries is a biofilm [plaque] induced acid
demineralization of enamel or dentin, mediated by saliva. Although
cavitated lesions have a bigger impact on children’s quality of life,
diagnosing and treating white spot lesions is very important for implementing
early intervention strategies and overcoming the aggressive course of early
childhood caries.
Carbonic anhydrase VI [CA VI] is the primary salivary
zinc metalloprotein responsible for regulation of buffer capacity and salivary
pH homeostasis by catalyzing
the hydration reaction. This enzymatic ability facilitates acid neutralization and
maintenance of pH in the oral cavity. Fluoride
release can prevent demineralization and promote the remineralization of early
WSLs.
In spite of the current understanding regarding the
role of CA VI in saliva and occurrence of caries, at least to our knowledge, no
study has investigated salivary CA VI concentration and activity of children
with white spot lesions before and after application of fluoride varnish. So,
the aim of the present study is to determine quantitatively salivary CA VI for
caries susceptibility in white spot lesions in preschool children. |