| 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
|
|
|
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
|
|
|
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. | |