| CTRI Number |
CTRI/2025/09/094927 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
16/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Evaluation of 3 Pit and Fissure Sealants |
|
Scientific Title of Study
|
Comparative Evaluation of 3 Pit And Fissure Sealants (PF Seal, Nanosilver Reinforced and Ultradent XT Hydro) in Permanent Molars Of Children (Age 7-12 Years) A 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 |
Dr Vidhi Gopalani |
| Designation |
PG Student |
| Affiliation |
Hitkarini Dental College and Hospital |
| Address |
10/14 South Civil Lines Pachpedhi
Room no 8
Ground floor
Department of Paediatric and preventive dentistry
Hitkarini dental college and Hospital
Jabalpur
Jabalpur
MADHYA PRADESH
482001
India |
| Phone |
09993611033 |
| Fax |
|
| Email |
drvidhigopalani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Debapriya Pradhan |
| Designation |
Head Of The Department |
| Affiliation |
Hitkarini Dental College And Hospital |
| Address |
A-401 Aakarsh Paradise Society Bilhari
Room no 8
Ground floor
Department of Paediatric and preventive dentistry
Hitkarini dental college and Hospital
Jabalpur
Jabalpur
MADHYA PRADESH
482020
India |
| Phone |
9619921096 |
| Fax |
|
| Email |
pradhandp@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Debapriya Pradhan |
| Designation |
Head Of The Department |
| Affiliation |
Hitkarini Dental College And Hospital |
| Address |
A-401 Aakarsh Paradise Society Bilhari
Room no 8
Ground floor
Department of Paediatric and preventive dentistry
Hitkarini dental college and Hospital
Jabalpur
Jabalpur
MADHYA PRADESH
482020
India |
| Phone |
9619921096 |
| Fax |
|
| Email |
pradhandp@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Room no 8
Ground floor
Department of Paediatric and preventive dentistry
Hitkarini dental college and Hospital
Jabalpur |
|
|
Primary Sponsor
|
| Name |
Dr Vidhi Gopalani |
| Address |
Hitkarini Dental College and Hospital Hitkarini Hills Dumna Road Jabalpur 482005 |
| 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 Vidhi Gopalani |
Hitkarini Dental College And Hospitals |
Room no 8
Ground floor
Department of Paediatric and preventive dentistry
Hitkarini dental college and Hospital
Jabalpur
Jabalpur
MADHYA PRADESH |
09993611033
drvidhigopalani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, (2) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nano Silver Reinforced |
Apply a thin layer of nano-silver reinforced pit and fissure sealant using an applicator tip/brush, ensuring it flows into the pits and fissures without overfilling; maintain a uniform minimal amount just sufficient to cover the fissure
and evaluate at baseline 3 months 6 months 12 months |
| Intervention |
PF Seal |
Apply a thin layer PF Seal pit and fissure sealant using an applicator tip/brush, ensuring it flows into the pits and fissures without overfilling; maintain a uniform minimal amount just sufficient to cover the fissure
and evaluate at baseline 3 months 6 months 12 months
|
| Intervention |
Ultradent XT Hydro |
Apply a thin layer of Ultradent XT Hydro pit and fissure sealant using an applicator tip/brush, ensuring it flows into the pits and fissures without overfilling; maintain a uniform minimal amount just sufficient to cover the fissure.
and evaluate at baseline 3 months 6 months 12 months |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Children of both genders aged 7–12 years with fully erupted permanent molars.
2.Parents who agreed to participate in the study.
3.Presence of sound proximal surfaces of the tooth
|
|
| ExclusionCriteria |
| Details |
1.Patients with bruxism, malocclusion, or allergies to dental resins or latex.
2.Parents who refused to participate in the study.
3.Wide self-cleansing pits and fissures.
4.Presence of proximal caries.
5.Deep caries requiring restoration or deep caries involving the pulp.
6.Children not cooperating for the treatment. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| colour , presence of caries and anatomic wear |
baseline, 3 months, 6 months, 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Marginal Integrity |
3 months, 6 months, 12 months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
29/09/2025 |
| 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="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
|
This study is randomised control trial, parallel group comparing and evaluating the efficacy of 3 pit and fissure sealants in terms of marginal integrity, colour, presence of caries and wear. There will be follow up scheduled after 3 months,6 months 12 months. |