FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
Close