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Tooth Surface Hardening Effect of Bioglass Containing Fluoride Coating on the White Coloured Spots present on Milk Teeth of Children with Childhood Caries in Comparison with Regularly used Fluoride Coating- A Clinical Study

Remineralization effect of bioactive glass fluoride varnish on white spot lesions in primary teeth of children with early childhood caries in comparison with conventional fluoride varnish a randomized controlled study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/08/071817
Enrollment
80
Registered
2024-08-02
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Health Condition 1: K026- Dental caries on smooth surface

Interventions

Intervention1: FluoroDip Bioactive Sodium fluoride containing dental varnish fortified with bioactive glass: 0.5 ml of varnish will be dispensed on glass dappen dish. Teeth will be air-dried, varnish

Sponsors

Manipal College of Dental Sciences Mangalore
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children with non-cavitated white spot lesions on the buccal and lingual surfaces of primary teeth with ICDAS score 1 (first visual change in enamel after air drying) and ICDAS score 2 (distinct visual change in enamel even when wet). Children exhibiting Franklâ??s definitely positive, positive and negative behaviour.

Exclusion criteria

Exclusion criteria: Children exhibiting Franklâ??s definitely negative behaviour. Children with systemic and mental illness. Tooth with cavitated lesions. Tooth nearing exfoliation time. Tooth with developmental defects. History of allergy to colophony base (resin).

Design outcomes

Primary

MeasureTime frame
The primary objective of this study will be to evaluate the extent of remineralization on the non-cavitated enamel white spot lesions on the primary teeth of children with ECC at 6 month and 1 year follow-up by bioactive glass fortified sodium fluoride varnish in comparison with conventional sodium fluoride varnish applied with an intensive application regimen (3 applications in two weeks), using laser fluorescence (DIAGNOdent).Timepoint: 6 month and 12 month follow up—

Secondary

MeasureTime frame
To assess the lesion activity status of the white spot lesions on the primary tooth surfaces of children with ECC using ICDAS-LAA classification at 6 month and 1 year follow-up after application of bioactive glass fortified sodium fluoride varnish in comparison with conventional sodium fluoride varnish. To assess the dental caries experience level of the children with ECC at 6 month and 1 year follow-up after application of bioactive glass fortified sodium fluoride varnish in comparison with conventional sodium fluoride varnish.Timepoint: 6 month and 12 month follow up—

Countries

India

Contacts

Public ContactDr Suprabha BS

Manipal College of Dental Sciences Mangalore

avneekalia@gmail.com9967987519

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026