| CTRI Number |
CTRI/2015/10/006288 [Registered on: 21/10/2015] Trial Registered Retrospectively |
| Last Modified On: |
28/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects of Fluoride varnish in preventing dental caries in 3-4 years old children in Rohtak district, Haryana |
|
Scientific Title of Study
|
Efficacy of fluoride varnish (5% sodium fluoride) in prevention of early childhood caries in 3-4 years old children in Rohtak district, Haryana – A 18 month prospective community based 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 |
Dr Adarsh Kumar |
| Designation |
Associate Professor |
| Affiliation |
Postgraduate Institute of Dental Sciences |
| Address |
Postgraduate Institute of Dental Sciences
Rohtak
Haryana
Rohtak
HARYANA
124001
India |
| Phone |
09468110075 |
| Fax |
|
| Email |
adarshkumar1980@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjunath BC |
| Designation |
Senior Professor |
| Affiliation |
Postgraduate Institute of Dental Sciences |
| Address |
Postgraduate Institute of Dental Sciences
Rohtak
Haryana
Rohtak
HARYANA
124001
India |
| Phone |
09416929911 |
| Fax |
|
| Email |
bcmanju10@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mamta Ghanghas |
| Designation |
Postgraduate Student |
| Affiliation |
Postgraduate Institute of Dental Sciences |
| Address |
Postgraduate Institute of Dental Sciences
Rohtak
Haryana
Rohtak
HARYANA
124001
India |
| Phone |
09416880999 |
| Fax |
|
| Email |
mamtaghanghas@gmail.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute of Dental Sciences
Rohtak,
Haryana
124001 |
|
|
Primary Sponsor
|
| Name |
Postgraduate Institute of Dental Sciences |
| Address |
Postgraduate Institute of Dental Sciences
Rohtak
Haryana |
| Type of Sponsor |
Other [Government Dental College] |
|
|
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 Mamta Ghanghas |
Postgraduate Institute of Dental Sciences |
Room no. 13
Department of Public Health Dentistry
Postgraduate Institute of Dental Sciences
Rohtak 124001
Haryana
Rohtak
HARYANA |
09416880999
mamtaghanghas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee PGIDS Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Dental caries |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
5% Sodium Fluoride Varnish |
0.3- 0.5ml biannual application |
| Comparator Agent |
no treatment |
no intervention in control group |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
4.00 Year(s) |
| Gender |
Both |
| Details |
Children in age group of 3-4 years.
Children present on the day of examination.
Children with dental caries
Children whose parents have given informed consent for fluoride varnish application and follow up for 18 months.
Children who are permanent residents of that area
|
|
| ExclusionCriteria |
| Details |
Children of parents with poor compliance
Children absent on the day of examination
Un-cooperative child
Child with systemic diseases and under long term medication
Child with congenital and developmental anomalies
Child with allergy to fluoride varnish
Children with stomatitis, gingivitis and large open lesion
Children with reduced mouth opening
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Net caries increment over the course of study |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Need for dental treatment, the cost of FV treatment, the acceptability of the preventive treatment and any side effects |
18 months |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
Final Enrollment numbers achieved (Total)= "575"
Final Enrollment numbers achieved (India)="575" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/10/2015 |
| Date of Study Completion (India) |
25/09/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
still in progress |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This postgraduate thesis study was a randomized, single blind, parallel group trial studying effects of 5% Fluoride varnish on dental caries among 3-4 years old children in Rohtak district, Haryana.The primary outcome measure was net caries increment over the period of 6 months, in which it was observed that net caries increment was significantly lower in the intervention group (0.879 ± 3.270) compared to the control group (2.154 ± 3.051) and prevented fraction of 59.19% .Unadjusted odds ratio for caries incidence was 1.441 times higher in the control than in the experimental group. These results corroborate findings from other studies where fluoride varnish was efficacious in preventing dental caries in young children. |