| CTRI Number |
CTRI/2016/02/006659 [Registered on: 18/02/2016] Trial Registered Retrospectively |
| Last Modified On: |
17/02/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of fluoride varnish when applied on decayed tooth of children of age group 3-5 years |
|
Scientific Title of Study
|
EFFECT OF FLUORIDE VARNISH APPLICATION IN PRIMARY DENTITION AMONG PRESCHOOL CHILDREN IN DHARAN: A RANDOMIZED CONTROLLED TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Santosh |
| Designation |
Junior resident of Department of Public Health Dentistry,MDS |
| Affiliation |
BP koirala Institute of Health Sciences |
| Address |
BPKIHS, Dharan18
BPKIHS Dharan18
NA
Other |
| Phone |
9842082407 |
| Fax |
025520251 |
| Email |
ishrita11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Guide DrAshish Shrestha |
| Designation |
MDS Head of the department Additional Professor |
| Affiliation |
BP koirala Institute of Health Sciences |
| Address |
BPKIHS, Dharan18
BPKIHS Dharan18
NA
Other |
| Phone |
9842155112 |
| Fax |
025520251 |
| Email |
asreta2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
santosh |
| Designation |
Junior resident |
| Affiliation |
BP koirala Institute of Health Sciences |
| Address |
BPKIHS, Dharan18
BPKIHS Dharan18
NA
Other |
| Phone |
9842082407 |
| Fax |
025520251 |
| Email |
ishrita11@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Santosh Kumari Agrawal |
| Address |
BPKIHS Dharan18 |
| Type of Sponsor |
Other [Self Invested] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
|
| NIL |
NIL |
| Santosh |
bpkihs dharan 18 |
|
|
Countries of Recruitment
|
Nepal |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Santosh Kumari Agrawal |
Government schools of Dharan Nepal |
Dharan Nepal
|
977-9842082407
025520251
ishrita11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Review committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy children having one or more than one decayed/missing/filled tooth |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
placebo with out active agents fluoride varnish |
0.5 ml will be painted on 20 primary teeth three application for 9 months |
| Intervention |
slow relaese topic fluoride varnish/fluoritop SR and placebo |
Fluoride varnish 0.5 ml once will be painted (Topical) on primary 20 teeth for 9 months in every 3 months interval. total 3 application in 9 months |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Child has decayed/missing/filled surfaces high risk group
child has plaque on teeth |
|
| ExclusionCriteria |
| Details |
child has a history of allergic reaction that required hospitalization
Presence of fixed orthodontic application
Participation in any other clinical study
children under 3 years
uncooperative child
child donot willing to take part in study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome is caries progression by 9 months will be measure by the changes from baseline
secondary outcome is caries incidence as measure by the proportion of children developing any new dentine caries during the study |
after 9 momths |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| caries incidence as measure by the proportion of children developing any new dentine caries during the study |
9monts |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/01/2015 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Applicable |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomized parallel placebo controlled trial conducted to see the effectiveness of fluoride varnish on dental caries among school children of aged 2-5 years. The primary outcome is to see the caries progression by 9months and secondary outcome is to measure the caries incidence. |