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.
- Conditions
- Early Childhood Caries
- Registration Number
- CTRI/2015/05/005800
- Lead Sponsor
- PriyadarshiniHR
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 200
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Any incidence of dental caries 6months,12months,18months,24months,30months and 36 months
- Secondary Outcome Measures
Name Time Method number of teeth and surfaces developing caries 3 years
Trial Locations
- Locations (1)
Government Dental College and research Institute
🇮🇳Bangalore, KARNATAKA, India
Government Dental College and research Institute🇮🇳Bangalore, KARNATAKA, IndiaDrPriyadarshiniHRPrincipal investigator9886648784reachdocpriya@rediffmail.com