| CTRI Number |
CTRI/2025/01/078852 [Registered on: 16/01/2025] Trial Registered Prospectively |
| Last Modified On: |
31/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of e-pit and fissure sealant with clinpro-f sealant for 6 months |
|
Scientific Title of Study
|
Comparative evaluation of resin based sealant & silver nanocrystals incorporated sealant on permanent molars in children A randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akhilesh |
| Designation |
Post graduate student |
| Affiliation |
The Oxford Dental College |
| Address |
Department of Pediatric & Preventive Dentistry, 4th floor, Room no 8
Bangalore
KARNATAKA
560068
India |
| Phone |
9880195409 |
| Fax |
|
| Email |
akhileshreddy11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Bharath Vardhana S |
| Designation |
Reader |
| Affiliation |
The Oxford Dental College |
| Address |
Department of Pediatric & Preventive Dentistry, 4th floor, Room no 8
Bangalore
KARNATAKA
560068
India |
| Phone |
9886588595 |
| Fax |
|
| Email |
bharath.dentist@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Akhilesh |
| Designation |
Post graduate student |
| Affiliation |
The Oxford Dental College |
| Address |
Department of Pediatric & Preventive Dentistry, 4th floor, Room no 8
Bangalore
KARNATAKA
560068
India |
| Phone |
9880195409 |
| Fax |
|
| Email |
akhileshreddy11@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Oxford Dental College
Department of Pediatric & Preventive Dentistry, 4th floor, Room no 8, Bommanahalli, NH 44, Bangalore
560068 |
|
|
Primary Sponsor
|
| Name |
Kidsedental |
| Address |
Kids-e-dental LLP Headquarters 411- Akruti Arcade JP road, Azad nagar, Opp A.H. Wadia school, Andheri west,Mumbai, India 400053 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Akhilesh N |
The Oxford Dental College |
Department of Pediatric & Preventive Dentistry, 4th floor, Room no 8
Bangalore
KARNATAKA |
9880195409
akhileshreddy11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy individual with occlusal pit and fissures
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Clinpro pit & fissure sealant |
Flouride based Pit and fissure sealant - 6 months |
| Intervention |
E-Pit & fissure sealant |
Silver nano particles incorporated sealant - 6 months |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy cooperative children with fully erupted permanent molars between the age of 6 to 9 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 |
• Uncooperative child.
• Children whose parents did not give consent for the study.
• Children with systemic disorders.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Retention of pit and fissure sealant |
1month, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| If retention is lost then secondary caries will be assessed using an explorer at 1,3 & 6 months |
1month, 3 months & 6 months |
|
|
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)
|
03/12/2025 |
| 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="0"
Months="6"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [akhileshreddy11@gmail.com].
- For how long will this data be available start date provided 16-05-2025 and end date provided 20-06-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Pit and fissure sealants have been widely used for more than four decades in preventing dental caries.1 The complex morphology of occlusal pits and fissures makes them an ideal site for retention of bacteria and food remnants. The most caries susceptible period of the first permanent molar is the long eruption phase as the enamel is immature during this period. Resin sealants that possess both low viscosity and excellent wetting properties have been recommended for dental use.2 Silver nanoparticles have recently been shown to possess bactericidal and bacteriostatic properties in various species of microorganisms.3 In dentistry, silver nanoparticles are used to improve the quality of the dental materials for a better treatment outcome.4 It is believed that the success of sealants is assessed by retention rate and caries prevention.5 Thus, the aim of the study is to evaluate and compare clinical efficacy of resin based sealant and silver nanocrystals incorporated sealant on permanent molars in children. |