| CTRI Number |
CTRI/2024/05/066694 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
03/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
To compare the clinical efficiency of conventional, nano silver reinforced, fluoride releasing pit and fissure sealants in children of age group 6-9 years |
|
Scientific Title of Study
|
An in vivo comparison of clinical efficacy of conventional, nano silver reinforced and fluoride releasing pit and fissure sealants in young permanent molars of children in the age group of 6-9 years |
| 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 DEVIPRIYA VEGESNA |
| Designation |
POST GRADUATE STUDENT, PEDODONTICS |
| Affiliation |
SRI SAI COLLEGE OF DENTAL SURGERY |
| Address |
SRI SAI COLLEGE OF DENTAL SURGERY,
DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY,
ROOM NO. 9,
1-2-64/1 AND 2
OPPOSITE SHIV SAGAR LAKE
KOTHREPALLY
VIKARABAD
TELANGANA
Hyderabad
TELANGANA
501102
India |
| Phone |
9603488888 |
| Fax |
|
| Email |
devipriyavegesna99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR CH SAMPATH REDDY |
| Designation |
HEAD OF THE DEPARTMENT |
| Affiliation |
SRI SAI COLLEGE OF DENTAL SURGERY |
| Address |
SRI SAI COLLEGE OF DENTAL SURGERY,
DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY,
ROOM NO. 9,
1-2-64/1 AND 2
OPPOSITE SHIV SAGAR LAKE
KOTHREPALLY
VIKARABAD
TELANGANA
Hyderabad
TELANGANA
501102
India |
| Phone |
9603488888 |
| Fax |
|
| Email |
sampathcheruku@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR CH SAMPATH REDDY |
| Designation |
HEAD OF THE DEPARTMENT |
| Affiliation |
SRI SAI COLLEGE OF DENTAL SURGERY |
| Address |
SRI SAI COLLEGE OF DENTAL SURGERY,
DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY,
ROOM NO. 9,
1-2-64/1 AND 2
OPPOSITE SHIV SAGAR LAKE
KOTHREPALLY
VIKARABAD
TELANGANA
Hyderabad
TELANGANA
501102
India |
| Phone |
9603488888 |
| Fax |
|
| Email |
sampathcheruku@yahoo.com |
|
|
Source of Monetary or Material Support
|
| SRI SAI COLLEGE OF DENTAL SURGERY,
DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY,
ROOM NO. 9,
1-2-64/1 AND 2
OPPOSITE SHIV SAGAR LAKE
KOTHREPALLY
VIKARABAD
TELANGANA
501102 |
|
|
Primary Sponsor
|
| Name |
DEVIPRIYA VEGESNA |
| Address |
SRI SAI COLLEGE OF DENTAL SURGERY,
DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY,
ROOM NO. 9
1-2-64/1 AND 2
OPPOSITE SHIV SAGAR LAKE
KOTHREPALLY
VIKARABAD
TELANGANA
501102 |
| 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 DEVIPRIYA VEGESNA |
SRI SAI COLLEGE OF DENTAL SURGERY |
SRI SAI COLLEGE OF DENTAL SURGERY,
DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY,
ROOM NO. 9,
1-2-64/1 AND 2
OPPOSITE SHIV SAGAR LAKE
KOTHREPALLY
VIKARABD
TELANGANA
501102
Hyderabad
TELANGANA |
9603488888
devipriyavegesna99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE 2023-24 |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CONVENTIONAL PIT AND FISSURE SEALANT |
CONVENTIONAL PIT AND FISSURE SEALANT APLLIED ON COMPLETELY ERUPTED YOUNG PERMANANT MOLARS WITH DEEP PITS AND FISSURES AND FOLLOWUP IS DONE AT 1 MONTH, 3 MONTH, 6 MONTH |
| Intervention |
FLUORIDE RELEASING PIT AND FISSURE SEALANT |
FLUORIDE RELEASING PIT AND FISSURE SEALANT APPLIED ON COMPLETELY ERUPTED YOUNG PERMANANT MOLARS WITH DEEP PITS AND FISSURES WITH FOLLOW UP AT 1 MONTH, 3 MONTH, 6 MONTH |
| Intervention |
NANO SILVER REINFORCED PIT AND FISSURE SEALANT |
NANO SILVER REINFORCED PIT AND FISSURE SEALANT APLLIED ON COMPLETELY ERUPTED YOUNG PERMANANT MOLARS WITH DEEP PITS AND FISSURES WITH FOLLOW UP AT 1 MONTH, 3 MONTH, 6 MONTH |
| Comparator Agent |
nil |
nil
|
| Comparator Agent |
NIL |
NIL |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Maxillary and mandibular first permanent molars with deep pits and fissures
The entire occlusal surface should be exposed, without the presence of operculum covering the tooth
Children whose parents gave consent
|
|
| ExclusionCriteria |
| Details |
Teeth with discoloration, restoration, cavitation or developmental defects
Partially erupted or erupting teeth are excluded
Children who are physically, mentally challenged or with gross orofacial defects or debilitating diseases.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare and evaluate the clinical efficacy of conventional, nano silver reinforced, fluoride releasing pit and fissure sealants by assessing retention, marginal adaptation, surface roughness, color change, fissure caries |
BASELINE, 4 WEEKS, 12 WEEKS, 24 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
05/08/2024 |
| 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="1"
Months="0"
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 - NO
|
|
Brief Summary
|
Pit and fissures of the occlusal surfaces of the posterior teeth are more prone to
caries development than the smooth surfaces due to their morphological
complexity, making dental hygiene more challenging leading to increased plaque
accumulation. The enamel in pits and fissures cannot receive the same
protection given by fluorides comparing to the enamel in the smooth surfaces. The
use of pit and fissure sealants provides a physical barrier that inhibits
microorganisms and food particles accumulation, preventing caries initiation,
and arresting caries progression. The management of occlusal caries on
permanent molars represents a significant challenge because the onset of
caries occurs soon after they erupt into the oral cavity. The effectiveness
of pit and fissure sealants relays on their long-term retention. This study
aims to compare the clinical performance of 3 different pit and fissure
sealants (different compositions). |