| CTRI Number |
CTRI/2020/04/024826 [Registered on: 23/04/2020] Trial Registered Prospectively |
| Last Modified On: |
15/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparing and clinically Evaluating the Retention Of Pit and Fissure Sealant With SDF/KI Pre-treatment and Without SDF/KI Pre-treatment in 6-8Year Old Children |
|
Scientific Title of Study
|
Clinical Evaluation Of Retention Of Pit and Fissure Sealant With and Without SDF/KI Pre-treatment in 6-8Year Old Children – A Randomized Control Trial
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Karthika D |
| Designation |
Post Graduate Student |
| Affiliation |
Indira Gandhi Institute of Dental Sciences, Pondicherry |
| Address |
Department of Pediatric and Preventive Dentistry, Indira Gandhi Institute of Dental Science,
MGMCRI Campus, SBV,
Pondicherry-Cuddalore,ECRoad,
Pondicherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
09790616258 |
| Fax |
|
| Email |
mail2karthika.devaraj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prathima GS |
| Designation |
Professor and Head |
| Affiliation |
Indira Gandhi Institute of Dental Sciences, Pondicherry |
| Address |
Department of Pediatric and Preventive Dentistry,Indira Gandhi Institute of Dental Science,
MGMCRI Campus, SBV,
Pondicherry-Cuddalore,ECRoad,
Pondicherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9448405074 |
| Fax |
|
| Email |
gsprathima@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Karthika D |
| Designation |
Post Graduate Student |
| Affiliation |
Indira Gandhi Institute of Dental Sciences, Pondicherry |
| Address |
Department of Pediatric and Preventive Dentistry, Indira Gandhi Institute of Dental Science,
MGMCRI Campus, SBV,
Pondicherry-Cuddalore,ECRoad,
Pondicherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
09790616258 |
| Fax |
|
| Email |
mail2karthika.devaraj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institute of Dental Science,
MGMCRI CAMPUS, SBV
PONDICHERRY-CUDDALORE, ECROAD
PONDICHERRY |
|
|
Primary Sponsor
|
| Name |
Karthika D |
| Address |
Indira Gandhi Institute of Dental Science,
MGMCRI CAMPUS, SBV
PONDICHERRY-CUDDALORE, ECROAD
PONDICHERRY |
| Type of Sponsor |
Other [No sponsorship] |
|
|
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 |
| KARTHIKA D |
Indira Gandhi Institute of Dental Science |
Department of Pediatric and Preventive Dentistry,Indra Gandhi Institute Of Dental Science,
MGMCRI Campus, SBV
Pondicherry-Cuddalore, ECRoad
Pondicherry
Pondicherry
PONDICHERRY |
09790616258
mail2karthika.devaraj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE,IGIDS |
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 |
pretreated with SDF/KI
|
Pit & fissure sealant
(Ultraseal XT hydro)
pretreated with SDF/KI
|
| Comparator Agent |
without pretreatment with SDF/KI |
Pit & fissure sealant (Ultraseal XT hydro) without pretreatment with SDF/KI (placebo -tonic-liquid) |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1)Teeth indicated for pit and fissure sealants
2)ICDAS codes 0, 1 and 2
3)Absence of restorations or prior sealants on the teeth under study
4)Absence of cavitated carious lesions
|
|
| ExclusionCriteria |
| Details |
1)Children with special health care needs
2)Teeth with cavitated dentinal caries
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Better retention of pit and fissure sealant pre-treated with SDF/KI at baseline, after 3 months and 6 months follow up |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Prevention of Pit and Fissure caries and better retention of pit and fissure sealant pre-treated with and without SDF/KI |
After 3 months |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
01/06/2020 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Objective of the study is:
a) To
evaluate the retention ability of pit and fissure sealant (Ultraseal XT hydro)
with SDF/KI pre-treatment in 6-8year old children on primary second molars and
first permanent molars clinically at baseline, after 3 months and 6 months
follow up
b) To
evaluate the retention ability of pit and fissure sealant (Ultraseal XT hydro)
without pre-treatment with SDF/KI in 6-8year old children on primary second
molars and first permanent molars clinically at baseline, after 3months and 6
months follow up
c) To
compare the retention ability of pit and fissure sealant (Ultraseal XT hydro)
pre-treated with and without SDF/KI
RESEARCH
HYPOTHESIS
Pre-treatment with SDF/KI increases the
retention ability of Pit and fissure Sealant (Ultraseal XT hydro) at various
intervals of follow up |