Caries-preventive effectiveness of adding an antibacterial agent to fluoride varnish among 4-6-year-old children

Effectiveness of adding an antibacterial agent (Povidone iodine or Chlorhexidine) to fluoride varnish on caries prevention among 4â??6-year-old school children â?? A randomized controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/08/035936

Enrollment

660

Registered

2021-08-25

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: 1% Chlorhexidine and 5% sodium fluoride varnish application: Two-step application procedure Child will be comfortably seated on the portable dental chair in upright position. Plaque wil

Eligibility

Inclusion criteria

Inclusion criteria: • Children aged 4-6 years of age in government schools of Chandigarh UT • Children whose parent/guardian gives informed consent

Exclusion criteria

Exclusion criteria: • History of allergy to fluoride varnish, chlorhexidine and povidone iodine • Children with debilitating illness/disease • Children with ongoing orthodontic treatment

Design outcomes

Primary

Measure	Time frame
Caries incrementTimepoint: Baseline, 3 months, 6 months, 1 year and 2 years	—

Secondary

Measure	Time frame
Nutritional statusTimepoint: Baseline, 3 months, 6 months, 1 year and 2 years;oral microflora including Mutans streptococci and other salivary parametersTimepoint: Baseline, 1 year and 2 years.;Tooth remineralization and gingival bleeding scoresTimepoint: Baseline, 3 months, 6 months, 1 year and 2 years	—

Countries

India

Contacts

Public ContactArpit Gupta

Postgraduate Institute of Medical Education and Research

arpitg.in@gmail.com8826674284

Outcome results