FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/091035 [Registered on: 16/07/2025] Trial Registered Prospectively
Last Modified On: 16/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study Comparing Two types of sealants glass ionomer and resin based sealant in childrens back teeth.  
Scientific Title of Study   Comparative evaluation of high viscocity glass ionomer based sealant and resin based sealant on permanent molars in children: An invivo 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 SHILPASHREE S 
Designation  POST GRADUATE 
Affiliation  The Oxford Dental College Bangalore 
Address  The Oxford Dental College Department of Pediatric and Preventive Dentistry, 4th floor,Room no.8,Bommanahalli, Hongasandra, Bangalore.
Department of Pediatric and Preventive Dentistry, 4th floor,Room no.8,Hongasandra, Bangalore.
Bangalore
KARNATAKA
560068
India 
Phone  9741894139  
Fax    
Email  shilpasuresh6790@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR SHILPASHREE S 
Designation  POST GRADUATE 
Affiliation  The Oxford Dental College Bangalore 
Address  The Oxford Dental College Department of Pediatric and Preventive Dentistry, 4th floor,Room no.8,Bommanahalli, Hongasandra, Bangalore.
Department of Pediatric and Preventive Dentistry, 4th floor,Room no.8,Hongasandra, Bangalore.
Bangalore
KARNATAKA
560068
India 
Phone  9741894139  
Fax    
Email  shilpasuresh6790@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR SNEHARAJ N 
Designation  READER 
Affiliation  The Oxford Dental College Bangalore 
Address  The Oxford Dental College Department of Pediatric and Preventive Dentistry, 4th floor,Room no.8,Bommanahalli, Hongasandra, Bangalore.
The Oxford Dental College Department of Pediatric and Preventive Dentistry, 4th floor,Room no.8,Bommanahalli, Hongasandra, Bangalore.
Bangalore
KARNATAKA
560068
India 
Phone  7259784347  
Fax    
Email  dr.sneharaj.n@gmail.com  
 
Source of Monetary or Material Support  
The Oxford Dental College 
 
Primary Sponsor  
Name  Dr Shilpashree S 
Address  The Oxford Dental College Department of Pediatric and Preventive Dentistry, 4th floor,Room no.8,Bommanahalli, Hongasandra, Bangalore. 
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 SHILPASHREE S  The Oxford Dental College  The Oxford Dental College Department of Pediatric and Preventive Dentistry, 4th floor,Room no.8,Bommanahalli, Hongasandra, Bangalore.
Bangalore
KARNATAKA 
9741894139

shilpasuresh6790@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  ICDAS SCORE: 0,1,2,3 PIT AND FISSURES OF PERMANENT MOLARS AGE 6-12 YEARS 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  HIGH VISCOCITY GLASS IONOMER BASED SEALANT{IONOSTAR PLUS}  Material will be mixed as per manufacturers instructions and will be placed on the pit and fissure of permanent molars 
Comparator Agent  RESIN BASED SEALANT [HELIOSEAL F PLUS}  Material will be placed on the pit and fissures of permanent molars and cured as per manufacturers instructions 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1)Healthy cooperative children with fully erupted permanent molars between the age of 6 to 12 years.
2)Deep pits and fissures are present in these permanent molars ICDAS II code 00.
3)Initial occlusal carious lesions involving the pits and fissures of enamel ICDAS II code 01.
4)Incipient carious lesion involving enamel ICDAS II code 02 and 03.
 
 
ExclusionCriteria 
Details  • Children whose parents did not give consent for the study.
• Medically compromised children.
• Children with enamel hypoplasia or any developmental anomalies.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
to evaluate and compare the clinical effectiveness of high-viscosity glass ionomer-based and resin based sealants in terms of retention, marginal adaptation and caries prevention on permanent molars in children.  Baseline- 4weeks
followup- 1month, 3month, 6month and 12 month 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   N/A 
Date of First Enrollment (India)   29/07/2025 
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="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  

Sixty permanent molars from children aged 6-12 years, who visits The Department of Pediatric and Preventive Dentistry at The Oxford Dental College and meet the inclusion criteria, will be selected for the study. The selected children will be assigned to two groups, with 30 permanent molars in each group.

Group 1: High viscocity glass ionomer based sealant.

Group 2: Resin based sealant.

The split mouth design will be chosen for 30 patients to compare two sealants, the high viscocity glass ionomer sealant, (IonoStar® Plus, VOCO) will be applied on permanent molar in one quadrant and the resin based sealant (Helioseal® F Plus, Ivoclar vivadent) on the contralateral side of the permanent molar as per the manufacturer’s instructions.

Prior to the application of sealant, the scaling procedure will be carried out, followed by prophylaxis using slurry of pumice and a rotating brush to ensure removal of plaque and debris from the enamel surfaces and fissures. ICDAS II scores will be assessed. Tooth will be isolated using minidam technique as per the manufacturer’s instructions(DMG).

The glass ionomer sealant material [Group 1] is available as capsules. The sealant is applied on the occlusal surface of the teeth following manufacturer’s instructions. The capsule must only be activated directly before use and loaded immediately into a high frequency amalgamator and mixed for 10 seconds. Capsule is removed from the mixer without delay and inserted in the holder of an application device, apply the material directly into the cavity within 10 seconds of the end of mixing by compressing the lever on the applicator slowly and evenly. Sealant can be worked for at least 1minute, material will be prevented from moisture contamination and protective varnish will be applied after the contours have been finished.

Similarly, the occlusal surface of the teeth in the contralateral side will be etched with 37% phosphoric acid for 15-30 seconds, rinsed thoroughly with water, air-dried for 5 seconds until a chalky-white enamel surface will be visible, followed by the application of [Group 2] resin based sealant to the fissure pattern by distributing with dental probe, prevent air bubbles from getting incorporated. It is then light cured for 10-20 seconds.

An explorer will be used to check complete coverage of pit and fissures of first permanent molars. The set sealants should be checked for high points with an articulating paper and if present, will be reduced with a finishing bur.

Patient will be instructed not to eat for at least one hour after the procedure.

The follow up examinations will be conducted at first, third, sixth and twelve months. At each recall visit, Modified United States Public Health Service (USPHS)/Modified Ryge criteria will be used to check for the retention and marginal adaptation of sealants using Community Periodontal Index of Treatment Needs (CPITN) probe. In case of sealant loss, ICDAS II will be used to check for caries.

 
Close