A clinical trial to study the effects of Fluoride varnish in preventing dental caries in 3-4 years old children in Rohtak district, Haryana

Efficacy of fluoride varnish (5% sodium fluoride) in prevention of early childhood caries in 3-4 years old children in Rohtak district, Haryana â?? A 18 month prospective community based randomized controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2015/10/006288

Enrollment

500

Registered

2015-10-21

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: 5% Sodium Fluoride Varnish: 0.3- 0.5ml biannual application Control Intervention1: no treatment: no intervention in control group

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Net caries increment over the course of studyTimepoint: 18 months	—

Secondary

Measure	Time frame
Need for dental treatment, the cost of FV treatment, the acceptability of the preventive treatment and any side effectsTimepoint: 18 months	—

Countries

India

Contacts

Public ContactDr Mamta Ghanghas

Postgraduate Institute of Dental Sciences

bcmanju10@rediffmail.com09416929911

Outcome results