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CTRI Number  CTRI/2024/03/064408 [Registered on: 19/03/2024] Trial Registered Prospectively
Last Modified On: 11/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trail to study the effects of resin modified glass ionomer varnish and resin infiltrant on initial carious lesions in primary teeth 
Scientific Title of Study   Comparative evaluation of effect of resin modified glass ionomer varnish and resin infiltrant on incipient carious lesions in primary teeth :A Randomised 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 Yogesh Kale 
Designation  Professor and Head of Department 
Affiliation  maharashtra institute of dental sciences and research,latur 
Address  Department of pediatric & preventive dentistry,MIDSR dental college Latur.

Latur
MAHARASHTRA
413512
India 
Phone  9890588705  
Fax    
Email  dryogesh77@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Yogesh Kale 
Designation  Professor and Head of Department 
Affiliation  maharashtra institute of dental sciences and research,latur 
Address  Department of pediatric & preventive dentistry,MIDSR dental college Latur.

Latur
MAHARASHTRA
413512
India 
Phone  9890588705  
Fax    
Email  dryogesh77@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Anamika Suryawanshi 
Designation  Post graduate student 
Affiliation  maharashtra institute of dental sciences and research,latur 
Address  Room no 6 ground floor Department of pediatric & preventive dentistry,MIDSR dental college Latur.

Latur
MAHARASHTRA
413512
India 
Phone  9890588705  
Fax    
Email  suryavanshiia@gmail.com  
 
Source of Monetary or Material Support  
Room no.6,Department of pediatric and preventive dentistry,Maharashtra institute of dental sciences and research dental college ,latur 
 
Primary Sponsor  
Name  Anamika suryawanshi 
Address  Room no.6,department of pediatric & preventive dentistry,Maharashtra institute of dental sciences and reserch dental college, latur 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Dr yogesh kale  Room no.6,department of pediatric & preventive dentistry,Maharashtra institute of dental sciences and research dental college, latur 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr yogesh kale  Maharashtra institute of dental sciences and research dental college, latur  Room no.6,department of pediatric & preventive dentistry,Maharashtra institute of dental sciences and research dental college, latur
Latur
MAHARASHTRA 
9890588705

dryogesh77@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Maharashtra university of health sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K026||Dental caries on smooth surface,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Resin infiltrant  Resin infiltrant (ICON®) -The tooth to be treated will be isolated. -The infiltration procedure will be carried out following the user manual. - Finishing and polishing will be done with fine-graded abrasive flexible discs, finishing strips, and rubber cups. -Total procedure will take 45 minutes to 1 hour overall. ASSESSMENT OF CARIES PROGRESSION FOR BOTH THE GROUPS WILL BE DONE AT 3,6,9 MONTHS INTERVAL. Pre and post Caries assessment, evaluation & progresssion will be done using : -Standardised ICDAS scale and Radiograph 
Comparator Agent  Resin modified glass ionomer varnish   Premeasured liquid and paste mix of the resin modified glass ionomer varnish will be dispensed from the clicker dispenser, mixed according to manufacturer’s instructions, and applied as a thin layer along the fissures using a micro-applicator tip.ASSESSMENT OF CARIES PROGRESSION FOR BOTH THE GROUPS WILL BE DONE AT 3,6,9 MONTHS INTERVAL. Pre and post Caries assessment, evaluation & progresssion will be done using : -Standardised ICDAS scale and Radiograph  
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  Child with incipient carious lesions on enamel surface or outer third of dentin
as by radiographic examination.
Non cavitated lesions assessed by ICDAS scale.
Parents willing to commit followup visits. 
 
ExclusionCriteria 
Details  Child with incipient carious lesions extending beyond the outer third of
dentin assessed by radiographic examination
Cavitated lesions assessed by ICDAS scale.
Known allergies to any material component or existing contact allergies. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
caries arresting ability of Resin modified glass ionomer varnish and Resin infiltrant on incipient carious lesions of primary
teeth.
 
9 months
 
 
Secondary Outcome  
Outcome  TimePoints 
caries prevention ability of Resin modified glass ionomer varnish & Resin infiltrant on incipient carious lesions of primary teeth.  1 year 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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 
Date of First Enrollment (India)   25/04/2024 
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="9"
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   Dental caries is a major public health concern commonly afecting children in their early childhood.It has a negative impact on childrens oral as well as general health. Special attention has been devoted to early incipient carious lesions, with maximum preservation of tooth structure. This is mainly because restorative therapy for interproximal lesions requires removal of a substantial amount of sound tissue and this brings tooth into a circle of treatment and retreatment. Therefore, early detection and treatment of such lesions will limit the need for invasive treatment in the future.
Infiltration Concept  is a relatively new resin product developedin Germany and used in the treatment of incipient lesions. It improves the retention and prevents caries on smooth surfaces, but not pit and fissure surfaces.Resin infiltration is a micro-invasive method that fills the incipient lesion pores via capillary action , which blocks further diffusion of the bacteria by creating barriers and stops lesion development, restoring the tooth without anaesthesia and drilling to preserve the natural anatomy of the tooth form. It infiltrates the lesion, make the bacteria inactive and prevents caries progression compared to the sealant which only work as mechanical barrier between the tooth structure and the oral environment.
Fluoride varnishes are effective in preventing caries and their administration is the method of choice to prevent demineralization, as well as to enhance the remineralization of non-cavitated carious lesions.Resin modified glass ionomer varnish is a site specific, light cured durable, fluoride releasing coating that provides an immediate layer of protection to relieve dentinal hypersensitivity, creates a barrier against demineralization and acid erosion and helps repair demineralized enamel adjacent to the coating. 
Hence this study focusses to clinically assess the efficacy of the Resin modified glass ionomer varnish versus Resin infiltrant on incipientcarious lesion.
 
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