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CTRI Number  CTRI/2026/03/106555 [Registered on: 19/03/2026] Trial Registered Prospectively
Last Modified On: 18/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparing three different types of dental sealants to check retention and decay prevention effect in children of 6 to 9 years. 
Scientific Title of Study   Comparative evaluation of retention and cariostatic effect of Nano-silver reinforced and fluoride-releasing pit and fissure sealant with conventional pit and fissure sealant in 6–9-year-old children: A Randomized controlled study. 
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 VAIDEHI KADU 
Designation  POST GRADUATE STUDENT 
Affiliation  Ranjeet Deshmukh Dental college and research centre 
Address  301 , DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY , 3RD FLOOR, RANJEET DESHMUKH DENTAL COLLEGE AND RESEARCH CENTRE

Nagpur
MAHARASHTRA
440016
India 
Phone  09823702100  
Fax    
Email  vaidehikadu74@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR GAGANDEEP LAMBA 
Designation  ASSOCIATE PROFESSOR AND GUIDE 
Affiliation  Ranjeet Deshmukh Dental college and research centre 
Address  301 , DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY , 3RD FLOOR, RANJEET DESHMUKH DENTAL COLLEGE AND RESEARCH CENTRE
DIGDOH HILLS, HINGNA ,NAGPUR
Nagpur
MAHARASHTRA
440016
India 
Phone  8983184861  
Fax    
Email  drgagandeeplamba@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR GAGANDEEP LAMBA 
Designation  ASSOCIATE PROFESSOR AND GUIDE 
Affiliation  Ranjeet Deshmukh Dental college and research centre 
Address  301 , DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY , 3RD FLOOR, RANJEET DESHMUKH DENTAL COLLEGE AND RESEARCH CENTRE
DIGDOH HILLS, HINGNA ,NAGPUR
Nagpur
MAHARASHTRA
440016
India 
Phone  8983184861  
Fax    
Email  drgagandeeplamba@gmail.com  
 
Source of Monetary or Material Support  
Ranjeet Deshmukh Dental College and Research Centre Hingna road, Digdoh hills, Police nagar,Nagpur, Maharashtra, India Pincode-440016 
 
Primary Sponsor  
Name  Ranjeet Deshmukh Dental College and Research Centre  
Address  Ranjeet Deshmukh Dental College and Research Centre Hingna road, Digdoh hills, Police nagar,Nagpur, Maharashtra, India Pincode-440016 
Type of Sponsor  Private medical college 
 
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 
DR VAIDEHI KADU  Ranjeet Deshmukh Dental College and Research Centre  301 , DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY , 3RD FLOOR, RANJEET DESHMUKH DENTAL COLLEGE AND RESEARCH CENTRE, Hingna road, Digdoh hills, Police nagar,Nagpur, Maharashtra, India Pincode-440016
Nagpur
MAHARASHTRA 		 9823702100

vaidehikadu74@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RDDCRCIEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy human volunteers refer to children aged 6–9 years with good general health and no systemic illness, having fully erupted, caries-free first permanent molars suitable for sealant application. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional pit and fissure sealanat  Conventional pit and fissure sealants are resin-based materials that provide a mechanical barrier by sealing pits and fissures, preventing food accumulation and bacterial colonization. They are considered the gold standard due to their high retention and durability, but they lack additional antibacterial or fluoride-releasing properties. 
Intervention  Fluoride-releasing pit and fissure   Fluoride-releasing pit and fissure sealants are materials that continuously release fluoride ions, helping in remineralization of enamel and inhibition of demineralization. Along with forming a physical barrier, they provide an added cariostatic effect, making them beneficial in caries-prone pediatric patients. 
Intervention  Nano-silver reinforced pit and fissure sealants  Nano-silver reinforced pit and fissure sealants are resin-based materials incorporated with silver nanoparticles, which provide antibacterial action by inhibiting cariogenic bacteria. In addition to forming a physical barrier, they offer a dual benefit of sealing and caries prevention, making them promising for pediatric patients 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  Children aged 6-9 years with fully erupted permanent first molars having deep fissures at risk of caries, DMF score 0-3 , sound non cavitated grade 0, 1 or 2 caries according to ICDAS criteria, and no previous restoration or sealant on the tooth were included in the study. 
 
ExclusionCriteria 
Details  Medically compromised children including those with respiratory disease, mentally or physically challenged patients, children with hypoplastic permanent first molars or other developmental anomalies, children with any signs of dental caries, and uncooperative children 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare retention and cariostatic effect of Nano-silver reinforced, fluoride-releasing and resin-based pit and fissure sealants when applied to permanent first molars in 6–9-year-old children.  1 month, 3months , 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To analyze marginal discoloration, marginal integrity and surface roughness of Nano-silver reinforced, fluoride-releasing and resin-based pit and fissure sealants.  1 month, 3months , 6 months 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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 4 
Date of First Enrollment (India)   01/04/2026 
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="1"
Months="6"
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  

This randomized controlled trial will compare the retention and cariostatic effect of Nano silver reinforced fluoride releasing pit and fissure sealant with conventional sealant in six to nine year old children. Caries free permanent first molars with deep pits and fissures will be randomly allocated into two groups. Retention and caries development will be evaluated at scheduled follow up visits using standardized criteria.


 
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