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Effectiveness of silver fluoride with or without potassium iodide in arresting tooth caries in children with mild intellectual disability

Caries management using silver fluoride in children with mild intellectual disability: A Randomized Controlled Trial - Nil

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/109503
Enrollment
42
Registered
2026-04-27
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: F70- Mild intellectual disabilities

Interventions

Intervention1: Silver Fluoride: 21 teeth will be assessed using the International Caries Detection and Assessment System (ICDAS II). Eligible lesions will receive silver fluoride application, and outc

Sponsors

Dr Vrushali Kalagate
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Children aged 6 12 years. 2)Presence of primary or permanent tooth with carious lesion. 3)Carious lesions with an ICDAS II score above 3. 4)Children with special healthcare needs, with: Mild intellectual disability as specified by Unique Disability Id Card Intelligence Quotient in the range of 55-69. Parents/guardians willing to provide written informed consent and agree to comply with follow-up visits and the potential for tooth discoloration.

Exclusion criteria

Exclusion criteria: 1)Child with history of allergy or hypersensitivity to silver compounds or potassium iodide. 2)Teeth exhibiting signs of irreversible pulpitis, pulpal exposure, or symptoms suggestive of pulpal pathology. 3)Teeth expected to exfoliate within the next 6 months. 4)Medically compromised children.

Design outcomes

Primary

MeasureTime frame
Clinical effectiveness of silver fluoride with and without potassium iodide in caries management in children with mild intellectual disability.Timepoint: Follow-up evaluations will be conducted at 1, 3, 6, and 12 months after the application of silver fluoride, with and without potassium iodide.

Secondary

MeasureTime frame
Evaluate the integrity of the tooth restoration after caries arrest and to monitor for any further progressionTimepoint: Assessments will be conducted at 1, 3, 6, and 12 months following the placement of the restoration

Countries

India

Contacts

Public ContactDr Vrushali Kalagate

A B Shetty Memorial Institute of Dental Sciences

dramarshreeshetty@nitte.edu.in98453 53251

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026