| CTRI Number |
CTRI/2024/11/076524 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
29/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the retention and marginal integrity of two pit and fissure sealants viz. moisture-tolerant and moisture-intolerant pit and fissure sealants, at 3 and 6 months, in permanent molars with deep pits and fissures susceptible to dental caries, in children aged 6 to 12 years. |
|
Scientific Title of Study
|
Comparative evaluation of retention of hydrophilic and hydrophobic pit and fissure sealants in permanent molars at 3 and 6 months - an in-vivo 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 Anand C Poal |
| Designation |
Post Graduate Student |
| Affiliation |
Maharishi Markandeshwar College of Dental Sciences and Research , Mullana, Ambala, Haryana |
| Address |
Department of Pediatric and Preventive Dentistry, Maharishi Markandeshwar College of Dental Sciences and Research, Maharishi Markandeshwar Deemed To Be University, Mullana, Ambala, Haryana.
Department of Pediatric and Preventive Dentistry, Maharishi Markandeshwar College of Dental Sciences and Research, Maharishi Markandeshwar Deemed To Be University, Mullana, Ambala, Haryana.
Ambala
HARYANA
133207
India |
| Phone |
9224233407 |
| Fax |
|
| Email |
anandpoal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. H. P. Suma Sogi |
| Designation |
Head of the Department, Department of Pediatric and Preventive Dentistry |
| Affiliation |
Maharishi Markandeshwar College of Dental Sciences and Research, Mullana, Ambala, Haryana. |
| Address |
Department of Pediatric and Preventive Dentistry, Maharishi Markandeshwar College of Dental Sciences and Research, Maharishi Markandeshwar Deemed To Be University, Mullana, Ambala, Haryana.
Maharishi Markandeshwar College of Dental Sciences and Research, Maharishi Markandeshwar Deemed To Be University, Mullana, Ambala, Haryana.
Ambala
HARYANA
133207
India |
| Phone |
8197793383 |
| Fax |
|
| Email |
hod.pedodontics@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anand C Poal |
| Designation |
Post Graduate Student |
| Affiliation |
Maharishi Markandeshwar College of Dental Sciences and Research, Mullana, Ambala, Haryana. |
| Address |
Department of Pediatric and Preventive Dentistry, Maharishi Markandeshwar College of Dental Sciences and Research, Maharishi Markandeshwar Deemed To Be University, Mullana, Ambala, Haryana.
Department of Pediatric and Preventive Dentistry, Maharishi Markandeshwar College of Dental Sciences and Research, Maharishi Markandeshwar Deemed To Be University, Mullana, Ambala, Haryana.
Ambala
HARYANA
133207
India |
| Phone |
9224233407 |
| Fax |
|
| Email |
anandpoal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatric and Preventive Dentistry, Maharishi Markandeshwar College of Dental Sciences and Research, Mullana, Ambala, Haryana |
|
|
Primary Sponsor
|
| Name |
Dr Anand C Poal |
| Address |
Department of Pediatric and Preventive Dentistry, Maharishi Markandeshwar College of Dental Sciences and Research, Mullana, Ambala, Haryana |
| 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 Anand C Poal |
Maharishi Markandeshwar College of Dental Sciences and Research, Mullana, Ambala, Haryana. |
Department of Pediatric and Preventive Dentistry, Maharishi Markandeshwar College of Dental Sciences and Research, Maharishi Markandeshwar Deemed To Be University, Mullana, Ambala, Haryana
Ambala
HARYANA |
9224233407
anandpoal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Maharishi Markandeshwar Institute of Medical Sciences and Research, Mullana, Ambala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K08||Other disorders of teeth and supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hydrophilic pit and fissure sealant |
Hydrophilic pit and fissure sealant is a moisture-resistant resin sealant and does not have bisphenol A-glycidyl methacrylate (bis-GMA).
Retention, marginal integrity and caries incidence to be checked at 3 and 6 months. |
| Comparator Agent |
Hydrophobic pit and fissure sealant |
Hydrophobic pit and fissure sealant is a conventional resin sealant based on bisphenol A-glycidyl methacrylate (bis-GMA).
Retention, marginal integrity and caries incidence to be checked at 3 and 6 months. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. 6 – 12 year old healthy children.
2. All fully erupted non carious permanent molars.
3. Contralateral molars.
4. No history of any fluoride application from last 6 months or sealant application on molars.
5. Children with high risk of caries.
6. Presence of bilateral maxillary and mandibular molars on both sides. |
|
| ExclusionCriteria |
| Details |
1. Children with hypoplastic teeth.
2. Uncooperative children. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Retention rates and marginal integrity of hydrophilic and hydrophobic pit and fissure sealants. |
3 and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Caries incidence after application of pit and fissure sealants. |
3 and 6 months. |
|
|
Target Sample Size
|
Total Sample Size="156"
Sample Size from India="156"
Final Enrollment numbers achieved (Total)= "48"
Final Enrollment numbers achieved (India)="48" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/11/2024 |
| Date of Study Completion (India) |
15/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
- 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 [anandpoal@gmail.com].
- For how long will this data be available start date provided 06-09-2025 and end date provided 06-09-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
- Hydrophilic sealants, which are materials that attract water, provide superior retention and marginal integrity, particularly in moisture-challenged clinical environments.
- Time is the most significant determinant of sealant degradation, affecting both retention and marginal integrity regardless of the type of material used.
- Mandibular teeth exhibited better long-term performance, likely due to favorable anatomical and functional factors, such as their position in the mouth and the way they interact with saliva and other oral fluids.
- Hydrophilic sealants, which are materials that attract water, demonstrated a more favourable pattern of degradation, characterized by partial retention rather than complete loss.
Overall, the present findings support existing evidence that hydrophilic sealants provide a distinct clinical advantage in moisture-challenged environments, particularly in pediatric patients. Their tendency toward partial retention rather than complete loss further supports their use as a preventive strategy when ideal isolation cannot be guaranteed.
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