| CTRI Number |
CTRI/2025/01/079575 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
18/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
A Clinical trial to study the effects of novel hydrophilic sealant and conventional sealant |
|
Scientific Title of Study
|
Development and Comparative evaluation of Novel Hydrophilic pit and fissure sealants added nanoparticles with Conventional Hydrophilic sealants for prevention of dental caries- An Experimental and Clinical 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 |
Jayashriprabakar |
| Designation |
Associate Professor |
| Affiliation |
Saveetha Dental College |
| Address |
Department of Public Health Dentistry.
Room No.22,
Saveetha dental college,No.162, Poonamallee High road, Velapanchavadi, thiruvallur district
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9841788803 |
| Fax |
|
| Email |
shrijaya2009@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Ganesh J |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College |
| Address |
Department of Pedodontics and Preventive Dentistry.
Room No.28,
Saveetha dental college,No.162, Poonamallee High road, Velapanchavadi, thiruvallur district
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9884293869 |
| Fax |
|
| Email |
helloganz@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jayashriprabakar |
| Designation |
Associate Professor |
| Affiliation |
Saveetha Dental College |
| Address |
Department of Public Health Dentistry.
Room No.22,
Saveetha dental college,No.162, Poonamallee High road, Velapanchavadi, thiruvallur district
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9841788803 |
| Fax |
|
| Email |
shrijaya2009@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRI clinic, No.19/2 ponnappa mudali street, vyasarpadi, chennai-600039,Tamilnadu,India. |
|
|
Primary Sponsor
|
| Name |
R Prabakar |
| Address |
SRI clinic, No.19/2 ponnappa mudali street, vyasarpadi, chennai-600039,Tamilnadu,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 |
| DrJayashri Prabakar |
SAVEETHA DENTAL COLLEGE |
DEPARTMENT OF PUBLIC HEALTH DENTISTRY, ROOM NUMBER: 22.
No.162, POONAMALLEE HIGH ROAD, VELAPANCHAVADI, CHENNAI-600077
Chennai
TAMIL NADU |
7904181675
shrijaya2009@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee- Saveetha Dental College |
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, (2) ICD-10 Condition: K025||Dental caries on pit and fissure surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Commercially available Hydrophilic sealant
|
hydrophilic sealants
Total duration- 5-10 minutes |
| Intervention |
Formulated Hydrophilic nano sealant
|
Calcium Fluoride nanoparticles, hydrophilic sealant.
Total duration- 5-10 minutes
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1.Bilateral mandibular first permanent molars which were fully erupted
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).
|
|
| ExclusionCriteria |
| Details |
Patients who were medically compromised, children with developmental defects/hypoplastic molars or caries affected teeth, teeth with restorations or partially retained sealant restorations, and partially erupted teeth were excluded |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| change of color around the sealant, sealant retention, marginal adaptation, roughness of sealant surface, and fissure caries development |
At Baseline, 1 month, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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 |
|
Date of First Enrollment (India)
|
30/01/2025 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Dental caries is a multifactorial disease caused by alteration in the composition of the bacterial biofilm, leading to an imbalance between the demineralization and remineralization processes and manifested by the formation of caries lesions in primary and permanent dentitions.The results of the studies conducted in developing countries revealed that more than 80% of caries lesions in primary and permanent teeth required restorative treatment.
There are two primary clinical preventive strategies for reducing the risk of dental caries: topical fluoride application and fissure sealant application. Topical fluoride application is a more effective method on smooth tooth surfaces, while pit and fissure sealants are used successfully on the occlusal tooth surface.
Three main types of materials are available as pit and fissure sealants: glass ionomer cements, compomers and resins. Though glass ionomer cements as well as resin modified glass ionomer cements exhibit excellent Fluoride release and cariostatic properties, it is not widely used in clinical practice owing to its poor retention rates.
Advanced moisture-tolerant resin-based sealant technology has been developed that performs well with and benefits from the persistent moisture in the mouth, allowing sealants to be placed on slightly moist teeth even during the early eruption. Some of the commercially available hydrophilic sealants are Embrace WetBond, Ultraseal XT hydro.
Furthermore , novel sealants incorporating nanotechnology have been developed and are gaining popularity in the field of dental research due to their physicochemical and biological properties, including biocompatibility, size, charge, large surface area, strength, solubility, chemical and surface reactivity, color, high stability, and thermal conductivity. As dentists are constantly faced with the challenges of existing pit and fissure sealants, there is a dire need to explore newer materials that can help overcome these drawbacks ultimately contributing to a healthy oral cavity.
Hence this study was undertaken with the aim of comparing the clinical effectiveness of a formulated hydrophilic nano sealant with a commercially available hydrophilic sealant.
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