| CTRI Number |
CTRI/2024/07/071229 [Registered on: 24/07/2024] Trial Registered Prospectively |
| Last Modified On: |
11/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical evaluation of retention of hydrophilic and hydrophobic pit and fissure sealants in primary molars-an in vivo study |
|
Scientific Title of Study
|
Clinical evaluation of retention of hydrophilic and hydrophobic pit and fissure sealants in primary molars-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 |
Neha Ola |
| Designation |
Post Graduate |
| Affiliation |
Surendera Dental College and Research Institute |
| Address |
Department of Pediatric and Preventive Dentistry Room no 6 Surendera Dental College and Research Institute His Highness Gardens Sri Ganganagar RAJASTHAN 335001
Ganganagar RAJASTHAN 335001 India |
| Phone |
08529777680 |
| Fax |
|
| Email |
nehaola1234@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Suruchi Juneja Sukhija |
| Designation |
Professor and Head |
| Affiliation |
Surendera Dental College and Reseach Institue Sriganganagar Rajasthan |
| Address |
Department of paediatric and preventive dentistry room no. 6 A-block Surendera Dental College and Research Institute His Highness Gardens Sriganganagar Rajasthan 335001
Ganganagar RAJASTHAN 335001 India |
| Phone |
9829365880 |
| Fax |
|
| Email |
drsuruchijuneja@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Neha Ola |
| Designation |
Post Graduate |
| Affiliation |
Surendera Dental College and Research Institute Sriganganagar Rajasthan |
| Address |
Surendera Dental College and Research Institute His Highness Gardens Sri Ganganagar RAJASTHAN 335001
Ganganagar RAJASTHAN 335001 India |
| Phone |
08529777680 |
| Fax |
|
| Email |
nehaola1234@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Neha Ola |
| Address |
Surendera Dental College and Research Institute,His Highness Gardens, Sri ganganagar, Rajasthan,335001, India |
| 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 Neha Ola |
Surendera Dental College and Research Institute |
Department of Pediatric and Preventive Dentistry room number 6 A Block Ganganagar RAJASTHAN |
08529777680
nehaola1234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Surendera Dental College and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patient opting dental treatment |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Clinpro 3M ESPE USA |
As conventional sealants are hydrophobic their major drawback is sensitivity to moisture, which ultimately leads to failure in retention of the sealant. This occurs because the tooth to be sealed are often partially erupted which precludes them to be properly isolated. Contamination with moisture can lead to poor retention. |
| Intervention |
UltraSeal XT Hydro ,Ultradent Germany |
New moisture tolerant sealants are hydrophilic, allowing them to create a strong bond for better retention in moist conditions making them ideal for children. So, this study aims to compare retention and marginal integrity using Ultraseal XT Hydro against the comparator agent Clinpro. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
Non-cavitated deep pit and fissures in primary molars.
3 to 7 years healthy children with primary molars present bilaterally.
No sign of occlusal caries.
Stained or minimal decalcified appearance of pits and fissures in molars.
|
|
| ExclusionCriteria |
| Details |
The occlusal surface of molars having shallow pit and fissures, which are self-cleansing in the oral cavity.
Unerupted/partially erupted on the contra lateral side.
Patients having any chronic medical diseases.
Patients receiving long term medication such as drugs affecting salivary flow.
Clinically detectable caries in molars.
Molars that cannot be isolated adequately.
Previously placed sealants or restorations on molar teeth.
Uncooperative children.
Hypo-calcification or developmental anomaly.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison and Evaluation of Retention, Color match, Marginal discoloration, Secondary caries, Wear, Marginal adaptation, Postoperative sensitivity between Clinpro and Ultraseal XT hydro pit and fissure sealants |
At 3,6 and 9 months interval |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison and Evaluation of Retention, Color match, Marginal discoloration, Secondary caries, Wear, Marginal adaptation, Postoperative sensitivity between Clinpro and Ultraseal XT hydro pit and fissure sealants |
At 3,6 and 9 months interval |
|
|
Target Sample Size
|
Total Sample Size="55" Sample Size from India="55"
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 3 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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="2" 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
|
Fissure sealants have been used in
pediatric dentistry since 1960s to prevent dental caries, particularly in
primary and permanent posterior teeth. They are recommended for individuals at
high risk for caries, those with multiple carious lesions, and those with deep,
narrow pits and fissures. Resin-based sealants are common and used with
phosphoric acid for etching, but they require good moisture control to be
effective. Numerous newer sealant materials have been
developed since the first dental sealant, Nuva Seal, was introduced in 1971.
The
resin-based sealant technology has also advanced to include a moisture tolerant
chemistry. Traditional sealants are hydrophobic and the major drawback of these
sealants is sensitivity to moisture, which ultimately leads to failure in the
retention of the sealant. This occurs because the tooth to be sealed are
partially erupted which precludes them to be properly isolated. Newer
moisture-tolerant sealants are hydrophilic, allowing them to create a strong bond for
better retention in moist conditions, making them ideal for children. Though there are numerous
studies on the retention of different sealant materials, there are only very
limited studies on the retention and evidence of caries after hydrophilic
sealant placement in primary molars. So, the aim of my study is to clinically
evaluate the retention of hydrophilic sealant against hydrophobic sealant. |