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CTRI Number  CTRI/2024/07/071229 [Registered on: 24/07/2024] Trial Registered Prospectively
Last Modified On: 11/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clinical evaluation of retention of hydrophilic and hydrophobic pit and fissure sealants in primary molars-an in vivo study 
Scientific Title of Study   Clinical evaluation of retention of hydrophilic and hydrophobic pit and fissure sealants in primary molars-An in vivo 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  Neha Ola 
Designation  Post Graduate 
Affiliation  Surendera Dental College and Research Institute 
Address  Department of Pediatric and Preventive Dentistry Room no 6 Surendera Dental College and Research Institute His Highness Gardens Sri Ganganagar RAJASTHAN 335001

Ganganagar
RAJASTHAN
335001
India 
Phone  08529777680  
Fax    
Email  nehaola1234@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Suruchi Juneja Sukhija 
Designation  Professor and Head 
Affiliation  Surendera Dental College and Reseach Institue Sriganganagar Rajasthan 
Address  Department of paediatric and preventive dentistry room no. 6 A-block Surendera Dental College and Research Institute His Highness Gardens Sriganganagar Rajasthan 335001

Ganganagar
RAJASTHAN
335001
India 
Phone  9829365880  
Fax    
Email  drsuruchijuneja@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Neha Ola 
Designation  Post Graduate 
Affiliation  Surendera Dental College and Research Institute Sriganganagar Rajasthan 
Address  Surendera Dental College and Research Institute His Highness Gardens Sri Ganganagar RAJASTHAN 335001

Ganganagar
RAJASTHAN
335001
India 
Phone  08529777680  
Fax    
Email  nehaola1234@gmail.com  
 
Source of Monetary or Material Support  
self funded 
 
Primary Sponsor  
Name  Neha Ola 
Address  Surendera Dental College and Research Institute,His Highness Gardens, Sri ganganagar, Rajasthan,335001, India 
Type of Sponsor  Other [Self] 
 
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 Neha Ola  Surendera Dental College and Research Institute  Department of Pediatric and Preventive Dentistry room number 6 A Block
Ganganagar
RAJASTHAN 
08529777680

nehaola1234@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Surendera Dental College and Research Institute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Patient opting dental treatment 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Clinpro 3M ESPE USA  As conventional sealants are hydrophobic their major drawback is sensitivity to moisture, which ultimately leads to failure in retention of the sealant. This occurs because the tooth to be sealed are often partially erupted which precludes them to be properly isolated. Contamination with moisture can lead to poor retention. 
Intervention  UltraSeal XT Hydro ,Ultradent Germany  New moisture tolerant sealants are hydrophilic, allowing them to create a strong bond for better retention in moist conditions making them ideal for children. So, this study aims to compare retention and marginal integrity using Ultraseal XT Hydro against the comparator agent Clinpro. 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  7.00 Year(s)
Gender  Both 
Details  Non-cavitated deep pit and fissures in primary molars.
3 to 7 years healthy children with primary molars present bilaterally.
No sign of occlusal caries.
Stained or minimal decalcified appearance of pits and fissures in molars.
 
 
ExclusionCriteria 
Details  The occlusal surface of molars having shallow pit and fissures, which are self-cleansing in the oral cavity.
Unerupted/partially erupted on the contra lateral side.
Patients having any chronic medical diseases.
Patients receiving long term medication such as drugs affecting salivary flow.
Clinically detectable caries in molars.
Molars that cannot be isolated adequately.
Previously placed sealants or restorations on molar teeth.
Uncooperative children.
Hypo-calcification or developmental anomaly.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment    
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparison and Evaluation of Retention, Color match, Marginal discoloration, Secondary caries, Wear, Marginal adaptation, Postoperative sensitivity between Clinpro and Ultraseal XT hydro pit and fissure sealants  At 3,6 and 9 months interval 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison and Evaluation of Retention, Color match, Marginal discoloration, Secondary caries, Wear, Marginal adaptation, Postoperative sensitivity between Clinpro and Ultraseal XT hydro pit and fissure sealants  At 3,6 and 9 months interval 
 
Target Sample Size   Total Sample Size="55"
Sample Size from India="55" 
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 3 
Date of First Enrollment (India)   01/08/2024 
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="2"
Months="0"
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  

         Fissure sealants have been used in pediatric dentistry since 1960s to prevent dental caries, particularly in primary and permanent posterior teeth. They are recommended for individuals at high risk for caries, those with multiple carious lesions, and those with deep, narrow pits and fissures. Resin-based sealants are common and used with phosphoric acid for etching, but they require good moisture control to be effective. Numerous newer sealant materials have been developed since the first dental sealant, Nuva Seal, was introduced in 1971.

The resin-based sealant technology has also advanced to include a moisture tolerant chemistry. Traditional sealants are hydrophobic and the major drawback of these sealants is sensitivity to moisture, which ultimately leads to failure in the retention of the sealant. This occurs because the tooth to be sealed are partially erupted which precludes them to be properly isolated. Newer moisture-tolerant sealants are hydrophilic, allowing them to create a strong bond for better retention in moist conditions, making them ideal for children. Though there are numerous studies on the retention of different sealant materials, there are only very limited studies on the retention and evidence of caries after hydrophilic sealant placement in primary molars. So, the aim of my study is to clinically evaluate the retention of hydrophilic sealant against hydrophobic sealant.


 
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