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Application of Silver Diamine fluoride as preventive agent for dental caries in children

Effectiveness Of Various Frequencies Of Application Of 38% Silver Diamine Fluoride (SDF)On cavitated Carious Lesion Of Primary Teeth of Pre-school children - SDFA

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/03/024265
Enrollment
480
Registered
2020-03-25
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

Health Condition 1: K029- Dental caries, unspecified

Interventions

Intervention1: Annual application of 38% SDF: 38% SDF will be applied at baseline only Intervention2: Biannual application of 38% SDF: 38% SDF will be applied at baseline and after 6 months. Control I

Sponsors

Amrita Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Parent of child understands importance of SDF treatment 2. Parents of child willing to accompany the child at regular interval for evaluation. 3. Child will be enrolled irrespective of special needs.

Exclusion criteria

Exclusion criteria: 1. Children with ulcerative gingivitis or stomatitis. 2. Developmental dental abnormalities such as enamel defects. 3. Cavitated teeth near to exfoliation. 4. Teeth with pulpal involvement. 5. Serious chronic medical condition such as congenital heart disease. 6. Any other significant disease or disorder which in the opinion of the investigator may either put the participants at risk because of participation in the trial or may influence the result of the trial or the participant ability to participate in the trial. 7. Any known silver allergy.

Design outcomes

Primary

MeasureTime frame
Arrested carious lesions - which is defined as 1. any teeth with treated carious lesions that are lost due to exfoliation will be referred as ARRESTED 2. teeth extracted due to caries progression will be referred as NOT ARRESTED. 3. caries progressed beyond dentin will be referred as NOT ARRESTED. 4. if the teeth is extracted due to fracture/trauma, will be EXCLUDED from the study.Timepoint: Baseline, 6 months, 12 months

Secondary

MeasureTime frame
NilTimepoint: Not applicable

Countries

India

Contacts

Public ContactDr Venkitachalam Ramanarayanan

Amrita School of Dentistry

indujadevan@gmail.com6238943620

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 15, 2026