| CTRI Number |
CTRI/2026/03/105442 [Registered on: 05/03/2026] Trial Registered Prospectively |
| Last Modified On: |
03/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison Of Flowable Composite And Resin -Based Sealants |
|
Scientific Title of Study
|
Comparison Of Flowable Composite And Resin -Based Sealants: A Split Mouth Randomized Control 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 |
Ashwini kurli |
| Designation |
Postgraduate student |
| Affiliation |
Government College Of Dentistry, Indore |
| Address |
Room no.13, Department of public health dentistry
Government college of dentistry, Indore
Indore
MADHYA PRADESH
452001
India |
| Phone |
8217715740 |
| Fax |
|
| Email |
ashwinikurli1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Punet Gupta |
| Designation |
Reader |
| Affiliation |
Government College Of Dentistry, Indore |
| Address |
Room no.13, Deprtment of public health dentistry
Government college of dentistry, Indore
MADHYA PRADESH
452001
India |
| Phone |
8217715740 |
| Fax |
|
| Email |
ashwinikurli1999@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashwini kurli |
| Designation |
Postgraduate student |
| Affiliation |
Government College Of Dentistry, Indore |
| Address |
Room no.13, Department of public health dentistry,
Government College Of Dentistry, Indore
Indore
MADHYA PRADESH
452001
India |
| Phone |
8217715740 |
| Fax |
|
| Email |
ashwinikurli1999@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Government college of dentistry, Indore |
| Address |
1,Sardar patel marg,opp M.Y.H , Indore- 452001,M.P |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrPuneet Gupta |
GOVERNMENT COLLEGE OF DENTISTRY |
Room no.13, Department of public health dentistry
Indore
MADHYA PRADESH |
9752153020
drpuneetgupta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government college of dentistry, Indore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K025||Dental caries on pit and fissure surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Flowable Composite |
Used In Contralateral Side Of Children 6-9 Years |
| Comparator Agent |
Resin Based Sealants |
Used In Children 6-9 Years |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1.children with fully erupted caries free mandibular permanent molar with retentive pits and fissures
2.possible cotton roll isolation |
|
| ExclusionCriteria |
| Details |
1.known allergy to any of the resin used
2. children with any history of systematic problem
3.clinically detectable caries
4.previously placed sealants or restorations
5.bruxism
6. uncooperative patients |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| retention |
3 months, 6 months, 9 months and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
time of application, MARGINAL
INTEGRITY, MARGINAL
DISCOLOURATION, SECONDARY CARIES |
3 months, 6 months, 9 months, 12 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/03/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The aim of this study is to compare the clinical performance (retention parameters and caries prevention) of flowable composite and resin-based pit and fissure sealants in children aged 9-12 yrs over a period of 1 year. Objectives are to measure the time and ease of application of flowable composite and resin based fissure sealants at baseline and compare the two. To measure the clinical effectiveness in terms of caries prevention of flowable composite and resin based fissure sealants at 3, 6 and 12 months, and compare the two. To measure the retention in terms of marginal integrity and marginal discoloration of flowable composite and resin-based fissure sealants at 3,6, and 12 months and compare the two. |