| CTRI Number |
CTRI/2015/05/005800 [Registered on: 22/05/2015] Trial Registered Retrospectively |
| Last Modified On: |
16/05/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
A Randomized trial to evaluate the combined effect of health education and fluoride varnish application on prevention of Early Childhood Caries in 2 year old children. |
|
Scientific Title of Study
|
Impact of Regular Maternal Education Combined with Intervention on Development and progression of Early Childhood Caries in 2 year old Children in Bangalore City†|
| Trial Acronym |
None |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrPriyadarshiniHR |
| Designation |
Reader |
| Affiliation |
Dr.Syamala Reddy Dental college,Hospital and Research Center |
| Address |
Dept of Public Health Dentistry
Dr.Syamala Reddy Dental College Hospital and Research Center
111 SGR College Road Munnekolala
Marathahalli Post
Bangalore
Research Scholar, Dept of Public Health Dentistry, Government Dental College and Research Institute
Fort Bangalore-560002 affiliated to Rajiv Gandhi University of Health sciences, Bangalore.
Bangalore
KARNATAKA
560037
India |
| Phone |
9886648784 |
| Fax |
918040980572 |
| Email |
reachdocpriya@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSSHiremath |
| Designation |
Professor and Head |
| Affiliation |
Oxford Dental College and hospital |
| Address |
Dept of Public Health Dentistry Oxford Dental College and Hospital Bommanahalli Hosur road
Bangalore.
Bangalore
KARNATAKA
560068
India |
| Phone |
09448466913 |
| Fax |
|
| Email |
hiremath29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSSHiremath |
| Designation |
Professor and Head |
| Affiliation |
Oxford Dental College and hospital |
| Address |
Dept of Public Health Dentistry Oxford Dental College and Hospital Bommanahalli Hosur road
Bangalore.
Bangalore
KARNATAKA
560068
India |
| Phone |
09448466913 |
| Fax |
|
| Email |
hiremath29@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PriyadarshiniHR |
| Address |
Research scholar, Dept of Public Health Dentistry, Government Dental College and Research Institute Fort Bangalore 560002 |
| 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 |
| DrPriyadarshiniHR |
Government Dental College and research Institute |
Dept of Public Health Dentistry,1st floor,Government dental college hospital and research institute
Vanivilasa hospital complex
Fort
Bangalore 560002
Bangalore
KARNATAKA |
9886648784
reachdocpriya@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Dental College and Research Institute, Victoria Hospital complex,Fort,Bangalore 560002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Early Childhood Caries |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
sodium fluoride varnish only |
0.2 ml of 5% sodium fluoride varnish from VOCO company applied to teeth of children once in 6 months for 3 years |
| Intervention |
Health Education only |
oral health education given to mothers once in 6 months for 3 years |
| Comparator Agent |
passive control |
no intervention given. But free treatment given in case of caries development |
| Intervention |
Sodium Fluoride varnish and Health Education |
0.2 ml of 5% sodium fluoride varnish from VOCO company applied to teeth of children once in 6 months for 3 years and oral health education given to mothers once in 6 months for 3 years |
|
|
Inclusion Criteria
|
| Age From |
24.00 Month(s) |
| Age To |
36.00 Month(s) |
| Gender |
Both |
| Details |
Inclusion Criteria:
Children boys or girls who have completed 24 months but not 36 months of age having full complement of primary teeth
Children whose parents are permanent residents of Bangalore.
|
|
| ExclusionCriteria |
| Details |
Children with any form of dental caries or enamel defectsor hypoplasia or fluorosis
Children with chronic systemic diseases
Children on long term oral medication immunosuppressive therapy
Children undergoing Chemotherapy or Radiotherapy
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Any incidence of dental caries |
6months,12months,18months,24months,30months and 36 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| number of teeth and surfaces developing caries |
3 years |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
18/08/2009 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="4"
Months="3"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This prospective cluster randomised double blind trial with 4 arms intended to evaluate effectiveness of combined intervention with fluoride varnish application in children and health education to their mothers as against single intervention with either fluoride varnish or health education on development and progression of early childhood caries in 2 year old children. The four arms were Education arm in which mothers recieved health education once every 6 months for 3 years, Varnish arm in which children recieved 0.2 ml of sodium fluoride varnish application on teeth once in 6 months for 3 years, combined arm in which both education to mothers and varnish application for children was given and control arm in which no intervention was given. Children were assessed for caries development every 6 months for 3 years. Primary outcome was any caries incidence. Free treatment was given to all children in 4 arms who developed dental caries during course of the study. |