Skip to content

A comparative clinical study on enamel remineralization of children using proanthocyanidin varnish and fluoride varnish

Comparative evaluation of effectiveness of non- fluoridated grape seed derived proanthocyanidin varnish and Fluoride varnish in remineralization of enamel caries of permanent teeth in children â?? A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/069792
Enrollment
56
Registered
2024-07-01
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Health Condition 1: K025- Dental caries on pit and fissure surface

Interventions

Intervention1: Proanthocyanidin(PAC) varnish: Formulated from Indegenous grape seed extract by maceration method. 20μg/mL Concentration of proanthocyanidin is used for the formulation. Application 3

Sponsors

Chettinad Dental College and Research Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Helathy Children aged 7-10 years. 2. Presence of early enamel caries (ICDAS II scores 1, 2, and 3) in occlusal surfaces of permanent molars on left and right quadrants. 3. Parental/guardian consent to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Children with systemic illnesses or children with special healhcare needs 2. Allergies to any of the study materials. 3. Tooth surfaces with proximal restorations; 4. Surfaces with evident proximal caries 5. Previous caries treatment on the selected teeth. 6. Use of fluoride supplements or professional fluoride treatments within the past six months

Design outcomes

Primary

MeasureTime frame
Change in ICDAS II scores from baseline to 9 months, comparing the effectiveness of fluoride varnish and PAC varnish application every 3 months.Timepoint: At 4 points Baseline 3 months 6 months 9 months

Secondary

MeasureTime frame
Change in (CIE) Lab color scores of digital photographs from baseline to 9 months.Timepoint: At 4 points Baseline 3 months 6 months 9 months

Countries

India

Contacts

Public ContactDr Daya Srinivasan

Chettinad Dental College and Research Institute

meena9thmay1997@gmail.com8637421819

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026